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Study Objectives
If the treatment combining Motivation Enhancement, Reduction Counseling, Nicotine Replacement Therapy and Transtheoretical tailored interventions produces an increasing treatment trajectory, it will produce unprecedented impacts with unmotivated smokers specifically and population cessation generally. These recruitment and intervention strategies require limited resources from health care providers and could be readily disseminable to other health care systems for application with populations of smokers, especially unmotivated smokers who have been understudied and underserved.
Conditions: Cancer
Intervention / Treatment:
BEHAVIORAL: TTM Tailored, BEHAVIORAL: Motivational Enhancement Therapy, BEHAVIORAL: Integrated Treatment
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: SINGLE | Inclusion Criteria:
* smoker
Exclusion Criteria:
* pregnancy | 19,347 |
Study Objectives
Latina breast cancer survivors report lower quality of life (QOL) than non-Latina survivors. Lower QOL can lead to poorer functional and cancer-related survival outcomes. The friends and family of Latina cancer patients are also impacted by a loved one's diagnosis of breast cancer. Through strong community-academic partnerships, the investigators seek to improve the QOL of Latina survivors and their caregivers with a culturally-relevant intervention. In this project, the investigators plan to further develop and refine the intervention and then test it through a randomized controlled trial. First, the investigators will conduct in-depth qualitative interviews with 10 survivor-caregiver dyads (pairs) to see if the intervention fits for survivors and caregivers in different parts of the country. Then, the investigators will revise the intervention. Finally, the investigators will test the intervention in a randomized controlled trial. The investigators will invite 125 survivor-caregiver dyads to be a part of our study. Half will be asked to complete the intervention and half will be offered the usual services, such as support groups. The information learned from this study could help improve the quality of life in Latina breast cancer survivors and their caregivers. Physicians, survivors, and community groups can also benefit from this study because they will have more information about the needs of Latina breast cancer survivors. The investigators hope to use the information to help other types of survivors and caregivers in the future.
Conditions: Quality of Life, Breast Cancer
Intervention / Treatment:
BEHAVIORAL: Nueva Vida Intervention
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Survivors: Latina, has been diagnosed with breast cancer, speaks English or Spanish, has a Caregiver who is willing to participate.
* Caregivers: a primary caregiver for a Latina breast cancer survivor, speak English or Spanish
Exclusion Criteria:
1. Inability to understand spoken English and/or Spanish and/or
2. Cognitive impairment that precludes informed consent (determined by the PIs or Co-Investigators who are mental health professionals). | 29,436 |
Study Objectives
The purpose of this study is to assess the safety and tolerability of ascending single oral doses of bosutinib administered with multiple doses of ketoconazole and to provide the pharmacokinetic profile of bosutinib when administered with multiple doses of ketoconazole and with food in healthy adult subjects.
Conditions: Breast Cancer, Tumors, Leukemia
Intervention / Treatment:
DRUG: Bosutinib (SKI-606)
Location: Netherlands
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose:
Allocation: RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: DOUBLE | Inclusion criteria:
1. Men or women of nonchildbearing potential (WONCBP) aged 18 to 50 years inclusive on study day 1. WONCBP may be included if they are either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for ≥ 1 year (with follicle-stimulating hormone \[FSH\] ≥ 38 mIU/mL) and must have a negative serum pregnancy test result before administration of test article.
2. Body mass index (BMI) in the range of 18.0 to 30.0 kg/m2 and body weight ≥ 50 kg.
3. Healthy as determined by the investigator on the basis of screening evaluations.
Exclusion criteria:
1. Family history QT prolongation, syncope, seizure, or unexplained cardiac related death.
2. Presence or history of any disorder that may prevent the successful completion of the study.
3. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. | 11,082 |
Study Objectives
After a curative treatment by radiotherapy for localized prostate cancer, between 20% and 50% of patients may have a biological relapse as a progressive re -rise of PSA. After prostate brachytherapy with low flow, this rate is between 2% and 6%. Depending on risk factors initially present, some patients will have a micro metastatic disease at the time of re-rise, but others will have a true local recurrence purely intra-prostate. Local recurrence after radiotherapy is associated with a high incidence of distant metastatic relapse and poor overall survival. For these reasons, the possibility of offering a local treatment for this selected population of patients can have a major therapeutic interest and allow changing a situation often considered palliative to the possibility of a second curative treatment.
Currently, there is no consensus regarding the optimal management of patients with purely local recurrence after prostate irradiation at first intention. When an external radiotherapy or brachytherapy is performed as first choice in a patient with prostate cancer, several remedial treatments have been proposed, with controversial results the decision-making for clinicians and for difficult patients. These main therapeutic options remedial (surgery, cryotherapy and brachytherapy) have the potential for complications such as rectal injury, impotence or incontinence Brachytherapy is a new salvage treatment being evaluated in the United States (Phase II study of the Radiation Therapy Oncology Group No. 0526). Several retrospective trials have shown very encouraging results in terms of acute toxicity and biochemical control in the short term. Thus, a team from Mount Sinai in New York recently published for the first time 10 years retrospective results with this approach. In their experience after treatment failures with external beam radiotherapy or brachytherapy, a dose of 122 Gy was delivered over 90% of the prostate gland. Doing this they observed biochemical control rates and survival specific of 54 % and 96 %, respectively at 10 years, with an hormone treatment associated (median 6 months) in 84 % of cases. Four patients had grade 3 toxicity or higher (11%). To reduce the rate of late toxicities the team from the University Of California San Francisco (UCSF), tested focal brachytherapy guided by functional MRI (MRI spectroscopy) to re-treat local recurrence after initial brachytherapy as monotherapy or boost. By delivering 144 Gy on recidivism objectified on MRI, the authors observed that a minimal dose of 37Gy covered 90 % of the prostate gland to treat the risk of microscopic disease. Doing this, the rate of observed toxicities and biochemical control appeared encouraging, with a median follow-up of 2 years, since no grade 3 toxicity was observed and 74% of patients achieved a PSA nadir \<0.5 ng / mL without associated hormone. In case of external radiation or brachytherapy, several attempts proposed to associate an injection of hyaluronic acid gel to the prostate - rectum interface to spare healthy tissue irradiated and thus reduce the rate of radiation proctitis. The feasibility of implementing this gel has been demonstrated in patients with non- irradiated tissues. No inherent toxicity of the injection of hyaluronic acid gel has been described after prostate brachytherapy first line. The feasibility of this injection remains unproven to date on patients previously irradiated externally or by brachytherapy. We hypothesize that the risk of radiation proctitis and fistulas front prostate could be reduced using this technique in this indication.
We propose to carry out a French prospective multicenter phase II trial combining brachytherapy remedial with an injection of hyaluronic acid after surgery to reduce the risk of radiation proctitis and / or recto -urinary fistula in a patient population hyper- selected with a high probability of isolated local recurrence.
Conditions: Recurrent Prostate Cancer, Brachytherapy Remedial
Intervention / Treatment:
RADIATION: brachytherapy remedial
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. localized prostate adenocarcinoma who presented as baseline characteristics: PSA ≤ 20ng/ml (with a rate of increase \<2ng/ml/an in the 18 months preceding the biopsy diagnosis), Gleason score ≤ 7 and T1c to t2c.
2. Indication of brachytherapy remedial validated
3. Prior treatment of prostatic adenocarcinoma by radiotherapy or brachytherapy
4. Recurrence histologically proven by biopsy within ≥ 24 months after the end of the first radiotherapy or brachytherapy
5. Re-rise of PSA biochemical assays on three successive but with a PSA recurrence \<10ng/ml
6. Patient over 18 years
7. WHO status 0 or 1
8. Information informed and signed by the patient or his legal representative
Exclusion Criteria:
1. Volume Prostate\> 50 cm3
2. proctitis and / or radiation cystitis grade ≥ 2 at the time of inclusion
3. Initial rT3a-RT4 at the time of recurrence (clinical or MRI)
4. Gleason score ≥ 8 (if it can be established after central review) at the time of recurrence
5. lymph node and bone metastases
6. invaded the seminal vesicles (diagnosed by MRI or biopsy)
7. History of prostatectomy, TURP, or cryoablation Ablatherm ®
8. node lymphadenectomy for "restaging" before salvage treatment
9. IPSS\> 12
10. Getting Started with hormone therapy since the diagnosis of recurrence
11. History of cancer within 5 years prior to entry into the trial other than basal cell skin
12. Patient already included in another clinical trial with an experimental molecule,
13. Persons deprived of liberty or under supervision (including guardianship)
14. Inability to undergo medical monitoring test for geographical, social or psychological reasons.
15. Contraindications to performing an MRI (metal prosthetic material, claustrophobia, pacemaker ...)
16. Patient anticoagulant Plavix or under
17. History of inflammatory bowel disease such as ulcerative colitis or Crohn's disease
18. History of rectal surgery | 27,522 |
Study Objectives
The purpose of the study is to address the following hypotheses: (i) Anti-PD-L1 therapy with MEDI4736 administered concomitantly with weekly nab-paclitaxel followed by MEDI4736 concomitant with ddAC neoadjuvant chemotherapy will induce higher pathologic complete response (pCR) rate (\>55%) in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone. (ii) MEDI4736 can be safely co-administered at full dose with sequential with nab-paclitaxel (100mg/m2) and ddAC (60 mg/m2 and 600 mg/m2 respectively).
Conditions: Breast Neoplasms
Intervention / Treatment:
DRUG: MEDI4736
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Newly diagnosed histologically confirmed stage I-III, ER, PR and HER2 negative invasive breast cancer as defined by the ASCO CAP guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard NCCN practice guidelines.
2. Willing and able to provide written informed consent for voluntary participation in the trial.
3. Willing to undergo a baseline tumor core needle biopsy and blood draws for correlative science studies.
4. Eighteen years of age or older on the day of signing informed consent.
5. Female subjects must either be of non-reproductive potential or must have a negative urine or serum pregnancy test upon study entry.
6. Patients should have adequate organ function to tolerate chemotherapy, as defined by:
* peripheral granulocyte count of \> 1,500/mm3
* platelet count \> 100,000/mm3
* hemoglobin \>9 g/dL
* total bilirubin \< 1.5 x upper limit of normal (ULN)
* aspartate aminotransferase (AST) and alanine aminotransferase (ALT) each \< 1.5 x ULN
* serum creatinine \< 1.5 x ULN or serum creatinine clearance \< 50mL/min
* INR/PT/PTT each \< 1.5 x ULN
* TSH within normal limits
Exclusion Criteria:
1. Patients who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node.
2. Patients for whom anthracycline, paclitaxel or antibody therapies are contraindicated.
3. Patients with active autoimmune disease or documented autoimmune disease within 2 years. Patients with hypothyroidism that is clinically stable and have normal TSH levels with hormone replacement, or patients with vitiligo or psoriasis not requiring treatment remain eligible for the study.
4. Active or prior documented inflammatory bowel disease (Crohn's disease, ulcerative colitis).
5. Patients with known active hepatitis B or C or HIV infection or with history of tuberculosis. | 9,928 |
Study Objectives
Primary Objectives:
1. To identify the optimal dose and pharmacokinetics of RAD001 in combination with trastuzumab in a Phase I trial
2. To determine the efficacy of RAD001 plus trastuzumab in HER-2-overexpressing patients with resistance to trastuzumab-based therapy for metastatic breast cancer in a Phase II trial.
1. Trastuzumab resistance will be defined as the development of progressive disease after trastuzumab-based therapy for metastatic breast cancer. Patients who develop metastases while receiving adjuvant or neoadjuvant trastuzumab will be eligible.
2. Efficacy would be measured by the rate of objective response plus stable disease lasting 6 months (complete response (CR) + partial response (PR) + stable disease SD).
Secondary objectives:
1. To determine the pharmacokinetics of RAD001 in combination with trastuzumab. In the phase II portion of the study, pharmacokinetic studies will be optional.
2. To determine the nature and degree of toxicity of RAD001 in combination with trastuzumab in this cohort of patients
3. To determine expression levels of total and phosphorylated mTOR and p70S6K-T389-P as well as relevant downstream signaling components (e.g., S6, 4E-BP1) in pre- and post- treatment tumor samples.
4. To correlate biomarker expression with response to therapy.
Conditions: Breast Cancer, Neoplasm Metastasis
Intervention / Treatment:
DRUG: Trastuzumab, DRUG: RAD001
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. History of biopsy-proven HER-2-overexpressing breast cancer and radiographic evidence of metastatic disease. The HER-2 status can be determined either by immunohistochemistry (score, 3+) or by fluorescence in situ hybridization.
2. History of trastuzumab resistance, defined as the development of progressive disease after trastuzumab-based therapy for metastatic breast cancer. Patient may not have received more than 2 prior trastuzumab-based regimens and one lapatinib-based regimen (either as single agent or in combination with chemotherapy)for metastatic breast cancer. Patients who develop metastatic disease during or after adjuvant or neoadjuvant trastuzumab are eligible.
3. Performance status 0-2 (by Eastern Cooperative Oncology Group (ECOG) scale).
4. Absolute neutrophil count (ANC) 1500/µl or higher; Platelets 100,000/µl or higher; Hemoglobin 9.0 gm/dL or higher; Serum creatinine 2.0 mg/dL or lower; Total bilirubin 1.5 mg/dL or lower; Serum glutamic pyruvic transaminase (SGPT) up to 3\* upper limit of normal; Alkaline phosphatase up to 3\* upper limit of normal; Calcium 11.0 mg/dL or lower.
5. Age 18 years or older.
6. Patients must not be pregnant. A pregnancy test will be obtained if the patient is a woman of child-bearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).
7. Patients must have signed an informed consent document stating that they understand the investigational nature of the proposed treatment.
8. Patients must have measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST). Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension with longest diameter \>/= 20 mm using conventional techniques or \>/= 10 mm with spiral computed tomography (CT) scan.
9. Patients may not be receiving any other investigational agents, and must not have received investigational agents within 15 days of enrollment.
10. Left ventricular ejection fraction determined by echocardiogram or multigated acquisition (MUGA) (cardiac scan) must be 50% or higher.
Exclusion Criteria:
1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
2. Prior treatment with any investigational drug within the preceding 15 days
3. Chronic treatment with systemic steroids or another immunosuppressive agent
4. Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases, and patients diagnosed with brain mets or leptomeningeal disease (LMD) within 3 months.
5. Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
6. A known history of HIV seropositivity
7. Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
8. Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin)
9. Patients who have received prior treatment with an mTor inhibitor.
10. History of noncompliance to medical regimens.
11. Patients unwilling to or unable to comply with the protocol.
12. Patients who are receiving any other investigational agents
13. Patients exhibiting confusion, disorientation, or having a history of major psychiatric illness that may impair the understanding of the informed consent. | 4,890 |
Study Objectives
90Y Ibritumomab tiuxetan (zevalin) has demonstrated consistently high response rates in patients who have received previous treatment for lymphoma. More than two-thirds of the patients who achieve CR go on to experience durable remissions lasting for years. Despite these highly promising clinical results with radioimmunotherapy (RIT) in relapsed follicular lymphoma there is very little data using RIT in previously untreated follicular lymphoma. The objective of this trial is to evaluate the safety and efficacy of two fractions of Zevalin in patients with previously untreated follicular lymphoma in a Phase II study.
Conditions: Follicular Lymphoma
Intervention / Treatment:
DRUG: 90Y Ibritumomab tiuxetan, DRUG: Rituximab
Location: France, United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients must have a histologically confirmed CD20 +ve follicular lymphoma grades I to IIIa.
* Patients with at least one of the following symptoms requiring initiation of treatment: (as outlined by the modified BNLI/GELF criteria below)
* Nodal mass \> 7cm in its greater diameter
* B symptoms
* Elevated serum LDH or beta2-microglobulin
* involvement of at least 3 nodal sites (each with a diameter \> 3 cm)
* symptomatic splenic enlargement
* compressive syndrome
* Patients must have an ECOG performance status less than or equal to 2 and an anticipated survival of at least 6 months.
* Patients must have an absolute granulocyte count of above 1,500/mm3, and a platelet count of above 100,000/mm3 post 4 weeks of unlabelled Rituximab. A hemoglobin \>= 8.0 g/dl
* Patients must have adequate renal function (defined as calculated creatinine clearance \> 30 ml/mn), hepatic function (defined as total bilirubin \<1.5 times upper limit of normal), and hepatic transaminases (defined as AST \<5 times upper limit of normal)
* Patients must have given informed consent prior to study entry.
Exclusion Criteria:
* Patients with a mean of \>20% of the intratrabecular marrow space involved with lymphoma on bone marrow biopsy following induction Rituximab therapy.
* Transformed follicular lymphoma and discordant lymphoma
* Patients with active obstructive hydronephrosis.
* Patients with initial disease bulk greater than 10cm.
* Patients with evidence of active infection requiring i.v. antibiotics at the time of study entry.
* Patients with congestive heart failure stage III or IV of NYHA classification, myocardial infraction or unstable angina within 6 months or other serious illness that would preclude evaluation.
* Patients with left VEF \< 40%
* Patients with large pleural or peritoneal effusions.
* Patients with known HIV infection or active HBV (HbsAg positivity) or HCV infection.
* Known Hypersensitivity to murine antibodies or proteins
* Patients who are pregnant or breast-feeding. Male and female patients must agree to use effective contraception for 12 months following 90Y-ibritumomab tiuxetan antibody therapy.
* Patients with prior malignancy other than lymphoma, except for adequately-treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years. | 16,954 |
Study Objectives
The study aimed to pilot the viability of a full scale randomised comparison of 2 steroid doses in malignant spinal cord compression, to establish safety of high dose dexamethasone in this setting in Australia, to test web registration and randomisation and to compare different functional outcome measures.
Conditions: Spinal Cord Compression From Neoplasm Metastasis
Intervention / Treatment:
DRUG: Dexamethasone
Location: Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Malignant spinal cord compression with at least one of pain, weakness, sensory disturbance or sphincter disturbance
* Histology not required if prior biopsy proven malignancy
* Any stage
* Age \>16 years
* ECOG 1-3 prior to cord compression event
* Minimum power 1 of 5 point scale Must not be paraplegic
* Minimum expected survival 2 months
* Relevant minimum lab values
* Patients capable of childbearing using adequate contraception
* Written informed consent
Exclusion Criteria:
* Prior radiotherapy to within vertebral±one level affected by cord compression
* Prior treatment for spinal cord compression at the current level
* Histology is lymphoma or myeloma
* Power less than 1 of 5
* More than 12 hours after initiation of dexamethasone\>4mg/24hr
* Pre-existing co-morbid conditions - peptic ulceration or cardiac failure
* Allergy to study medications
* Multilevel cord compression or meningeal carcinomatosis
* Pregnant or lactating | 5,640 |
Study Objectives
Non-small cell lung cancer patients may have brain metastases at diagnosis. Patients with brain metastasis may contribute as poor prognosis factors. This trial aims to explore the efficacy and the safety of immune checkpoint inhibitors in non small cell lung cancer patients with initial brain metastasis.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DRUG: immune therapy
Location: China
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* 1.Diagnosed with advanced non-small cell lung cancer 2.Patients with brain metastasis 3. Treated with ICIs
Exclusion Criteria:
* 1.Patients with a clear driver mutation that can be targeted for first-line treatment | 15,597 |
Study Objectives
This randomized phase II trial studies OPT-821 and vaccine therapy to see how well they work compared with OPT-821 alone in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer that has decreased or disappeared, but the cancer may still be in the body. Biological therapies, such as OPT-821, may stimulate the immune system in different ways and stop tumor cells from growing. Vaccines may help the body build an effective immune response to kill tumor cells. It is not yet known whether OPT-821 is more effective with or without vaccine therapy in treating patients with ovarian epithelial cancer, fallopian tube cancer, or peritoneal cancer.
Conditions: Stage IA Fallopian Tube Cancer, Stage IA Ovarian Cancer, Stage IB Fallopian Tube Cancer, Stage IB Ovarian Cancer, Stage IC Fallopian Tube Cancer, Stage IC Ovarian Cancer, Stage IIA Fallopian Tube Cancer, Stage IIA Ovarian Cancer, Stage IIB Fallopian Tube Cancer, Stage IIB Ovarian Cancer, Stage IIC Fallopian Tube Cancer, Stage IIC Ovarian Cancer, Stage IIIA Fallopian Tube Cancer, Stage IIIA Ovarian Cancer, Stage IIIA Primary Peritoneal Cancer, Stage IIIB Fallopian Tube Cancer, Stage IIIB Ovarian Cancer, Stage IIIB Primary Peritoneal Cancer, Stage IIIC Fallopian Tube Cancer, Stage IIIC Ovarian Cancer, Stage IIIC Primary Peritoneal Cancer, Stage IV Fallopian Tube Cancer, Stage IV Ovarian Cancer, Stage IV Primary Peritoneal Cancer
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, BIOLOGICAL: Polyvalent Antigen-KLH Conjugate Vaccine, BIOLOGICAL: Saponin-based Immunoadjuvant OBI-821
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* Patients with histologically documented epithelial carcinoma arising in the ovary, fallopian tube, or peritoneum, of any stage or grade at diagnosis; all patients must have had cytoreductive surgery and chemotherapy with at least one platinum-based chemotherapy regimen as part of primary treatment
* Patients who recurred on or after initial therapy, and are now in a second or third complete clinical remission and who are within four months of their last treatment are eligible; complete clinical remission is defined as serum cancer antigen (CA)-125 within institutional normal limits, negative physical examination, and no definite evidence of disease by computed tomography (CT) of the abdomen and pelvis; lymph nodes and/or soft tissue abnormalities =\< 1.0 cm are often present in the pelvis and will not be considered definite evidence of disease; eligibility is determined by anatomical imaging only (ie. magnetic resonance imaging \[MRI\] or CT); a positive positron emission tomography (PET) image (if performed) will not exclude a patient if other criteria are met and anatomical imaging is negative
* Absolute neutrophil count (ANC) greater than or equal to 1,000/mm\^3, equivalent to Common Toxicity Criteria for Adverse Events (CTCAE version \[v\]4.0) grade 1
* Platelets greater than or equal to 100,000/mm\^3
* Serum creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v4.0 grade 1
* Bilirubin less than or equal to 2.5 x ULN
* Serum glutamic oxaloacetic transaminase (SGOT), serum glutamate pyruvate transaminse (SGPT) less than or equal to 2.5 x ULN
* Alkaline phosphatase less than or equal to 2.5 x ULN
* Patients must have a Gynecological Oncology Group (GOG) performance status of 0, 1, or 2
* Patients who have signed the informed consent document and signed the authorization permitting release of personal health information
* Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and must be practicing an effective form of birth control; nursing mothers are excluded
Exclusion Criteria:
* With the exception of non-melanoma skin cancer, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 5 years or whose previous cancer treatment contraindicates this protocol therapy are excluded
* Patients whose circumstances at the time of entry onto the protocol would not permit completion of study or required follow up
* Patients who have an allergy to shellfish | 43,729 |
Study Objectives
Nivolumab is an approved treatment option for patients with previously treated advanced NSCLC, based on the survival benefit shown versus docetaxel in randomized phase III trials in second line. However, the profile of treatment and even patient outcomes are often different in routine clinical practice than in a clinical trial setting. Furthermore, the financial impact of an approved therapy is often largely unknown. This study will record the efficacy and tolerability of Nivolumab in previously treated patients with NSCLC and describe the treatment patterns and economic impact in real-world settings in Greece.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients with a diagnosis of advanced Squamous or Non-Squamous NSCLC (histologically or cytologically confirmed), who had relapsed after 1 prior platinum-based systemic treatment and who received treatment with nivolumab
* nivolumab treatment received in participating HeCOG centres between October 2015 and November 2019
* Alive patients must have signed and dated the study approved written informed consent form in accordance with regulatory and institutional guidelines, obtained before any protocol-related procedures that are not part of normal patient care.
Exclusion Criteria:
* Alive patients who do not want to sign and date the study approved written informed consent form
* Patients that participated in any other clinical trial prior or after nivolumab treatment | 5,292 |
Study Objectives
Since there is a limited amount of evidence on the feasibility and outcomes on the use of hand massage in patients undergoing cancer treatment, the purpose of this study is to evaluate the feasibility and outcomes of hand massage therapy in cancer patients undergoing chemotherapy, and to measure its influence on their symptoms.
Conditions: Cancer
Intervention / Treatment:
BEHAVIORAL: Caring Hand Massage
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Patients age 18 - 80
2. Patient receiving treatment on Mayo Clinic's Chemotherapy Outpatient Clinic
3. Able to speak English and complete surveys
4. Able to read, understand and sign inform consent.
Exclusion Criteria:
1. Patient has rash, sores, wounds, incision or other skin conditions on hands
2. Unable to give consent or complete the surveys
3. Already having received previous hand massage
4. Pregnant women. (As verbalized by participant) | 31,178 |
Study Objectives
The purpose of this research study is to determine if armodafinil is safe and effective in treating fatigue in patients with malignant gliomas undergoing treatment with radiotherapy plus temodar. Armodafinil is a wakefulness-promoting agent that has been FDA approved for the treatment of excessive daytime sleepiness for a variety of disorders. Armodafinil may also help to reduce radiation-induced fatigue in brain tumor patients.
Conditions: Malignant Glioma
Intervention / Treatment:
DRUG: Armodafinil, OTHER: Placebo
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* 18 years of age or older
* Histologically confirmed malignant glioma including anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic oligoastrocytoma (WHO grade III/IV), glioblastoma multiforme (WHO grade IV) or gliosarcoma. Patients with a grade II astrocytoma, mixed oligo-astrocytoma or oligodendroglioma who are being treated with irradiation are also eligible
* Scheduled to receive irradiation to a total dose of 50-60 Gy. Patients receiving hyperfractionated radiotherapy are also eligible
* KPS of 70% or greater
* Electrolytes within normal institutional limits: BUN and Creatinine \< 2.5 x ULN: AST, ALT, Bilirubin \< 2.5 x ULN
* Able to swallow medication
Exclusion Criteria:
* History of recent cardiac arrhythmia or unstable angina
* Has taken a psychostimulant or a monoamine oxidase inhibitor on a regular basis within the past 30 days
* Clinically significant untreated sleep apnea
* A history of clinically significant cardiac disease, including a history of recent myocardial infarction, history of unstable angina, history of left ventricular hypertrophy, or a history of ischemic ECG changes, chest pain, arrhythmia, or other clinically significant manifestations of mitral valve prolapse in association with use of CNS stimulants (e.g. caffeine, amphetamines, methylphenidate)
* Uncontrolled hypertension, alcohol or drug abuse, severe headaches, glaucoma, narcolepsy, clinically significant untreated sleep apnea, psychotic disorder or Tourette's syndrome
* Patients taking warfarin for anticoagulation are eligible, but monitoring of prothrombin times is suggested as a precaution
* Hemoglobin level of less then 11 g/dl
* Laboratory evidence of hypothyroidism with an elevated TSH concentration in the blood greater than 5.0 mlU/L
* Current treatment or history of psychotic disorder, bipolar disorder, or anxiety disorder
* Patients with a score of \> 28 on the Beck depression inventory consistent with severe depression
* Known hypersensitivity to armodafinil or related compounds
* Patients who have been receiving MAO inhibitors during the past 14 days | 24,517 |
Study Objectives
The purpose of this study is to evaluate the safety and immune response of different doses of RNF43-721 emulsified with Montanide ISA 51 in combination with S-1/CPT-11 chemotherapy.
Conditions: Colorectal Cancer
Intervention / Treatment:
BIOLOGICAL: RNF43-721
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* ECOG performance status 0-1
* Life expectancy \> 3 months
* HLA A24 positive
* Histologically diagnosed as colorectal cancer with measurable lesion
* Laboratory values as follows:WBC\>3000/mm3, Hb\>10mg/dl, Plt\>75000/mm3, Creatinine\<1.2mg/dl, T. bil.\<1.5mg/dl, AST, ALT\<3x normal limits
* Able and willing to give valid written informed consent
Exclusion Criteria:
* Active other malignancy
* Active infection
* Immune deficiency
* Current treatment with steroids and immunosuppressive agents
* Pregnancy and breast feeding
* Inability oral intake
* Psychic disease
* Hepatitis B, C virus
* HIV infection | 31,239 |
Study Objectives
This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).
Conditions: B-cell Lymphomas (Phase 1), Advanced Solid Tumors (Phase 1), Diffuse Large B-cell Lymphoma (Phase 2), Follicular Lymphoma (Phase 2), Transformed Follicular Lymphoma, Primary Mediastinal Large B-Cell Lymphoma
Intervention / Treatment:
DRUG: Tazemetostat, DRUG: Prednisolone, DRUG: Tazemetostat
Location: Taiwan, Ukraine, Poland, Germany, United States, Canada, Australia, France, United Kingdom, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Phase 1: Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Phase 2: ECOG performance status of 0 to 2.
2. Life expectancy of at least 3 months before starting tazemetostat.
3. Voluntary agreement to provide written informed consent and willing to adhere to all protocol requirements
4. Subjects with Hepatitis B or C are eligible on the condition that subjects have adequate liver function and are hepatitis B surface antigen negative and/or have undetectable hepatitis C virus (HCV) RNA.
5. Adequate renal and liver function
6. Phase 1: Males or females aged ≥ 16 years at time of informed consent. Phase 2: Males or females aged ≥ 18 years at the time of informed consent .
7. Females must not be lactating or pregnant at screening or baseline as documented by a negative pregnancy test All females will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrheic, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least 1 month before dose). Females of childbearing potential must not have had unprotected sexual intercourse within 30 days prior to study entry and must agree to use a highly effective method of contraception, from the last menstrual period prior to randomization, during Treatment Cycles, and for 6 months after the last final dose of study drug; any male partner must use a condom.
8. Male subjects must have had a successful vasectomy (with confirmed azoospermia) or they and their female partner must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception and use a condom throughout the study period and for 3 months after study drug discontinuation). Nonvasectomized male subjects must also agree to refrain from donating sperm from first dose of tazemetostat until 3 months following the last dose of tazemetostat
9. Phase 1 only: Histologically and/or cytologically confirmed advanced or metastatic solid tumor or B-cell lymphomas that have progressed after treatment with approved therapies or for which there are no standard therapies available.
10. Phase 2, Groups 1-6 only: Subjects must satisfy all of the following criteria:
1. Have histologically confirmed DLBCL (including primary mediastinal B-cell lymphoma), with relapsed or refractory disease following at least 2 lines of prior standard therapy, including alkylator/anthracycline (unless anthracycline-based chemotherapy is contraindicated)/anti-CD20-based therapy (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone \[R-CHOP\] or equivalent) AND must be considered unable to benefit from intensification treatment with autologous hematopoietic stem cell transplantation (ASCT) as defined by meeting at least 1 of the following criteria:
* Relapsed following, or refractory to, previous ASCT
* Did not achieve at least a partial response to a standard salvage regimen (eg, rituximab, ifosfamide, carboplatin, and etoposide phosphate \[R-ICE\] or rituximab, dexamethasone, cytarabine, and cisplatin \[R-DHAP\])
* Ineligible for intensification treatment due to age or significant comorbidity
* Ineligible for intensification treatment due to failure to mobilize an acceptable number of hematopoietic stem cells
* Refused intensification treatment and/or ASCT or
2. Have histologically confirmed Follicular Lymphoma (FL), all grades. Subjects may have relapsed/refractory disease following at least 2 standard prior systemic treatment regimens where at least 1 anti-CD20-based regimen was used. Subjects with prior radiotherapy will be included; however, radiotherapy alone will not be considered a systemic treatment regimen.
3. Have provided sufficient archival tumor tissue that has been successfully tested for EZH2 mutation status and cell of origin (DLBCL only)
4. Have measurable disease as defined by International Working Group-Non-Hodgkin's Lymphoma (IWG-NHL)
Exclusion Criteria:
1. Prior exposure to tazemetostat or other inhibitor(s) of EZH2.
2. Subjects with leptomeningeal metastases or brain metastases or history of previously treated brain metastases.
3. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 4.03 criteria) and any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
4. Has a prior history of T-cell lymphoblastic lymphoma(T-LBL) or T-cell lymphoblastic leukemia (T-ALL).
5. Subjects taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. Johns Wort) 6. Subjects unwilling to remove Seville oranges, grapefruit juice and grapefruit from their diet.
6. Any unstable or unresolved prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) toxicities at time of enrollment.
7. Major surgery within 4 weeks before the first dose of study drug. .
8. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of tazemetostat.
9. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months of the first dose of study drug; or cardiac ventricular arrhythmia.
10. Venous thrombosis or pulmonary embolism within the last 3 months before starting tazemetostat.
11. Active infection requiring systemic therapy.
12. Immunocompromised patients, including patients known to be infected with human immunodeficiency virus (HIV).
13. Any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in this study.
14. Females who are pregnant or breastfeeding.
15. Phase 2 only: Subjects with noncutaneous malignancies other than B-cell lymphomas. Exception: Subjects with another malignancy who have been disease-free for 5 years, or subjects with a history of a completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. | 45,032 |
Study Objectives
This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably
Conditions: Arthralgia, Musculoskeletal Complications, Pain, Recurrent Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Intervention / Treatment:
DRUG: letrozole, DIETARY_SUPPLEMENT: calcium carbonate, OTHER: laboratory biomarker analysis, DIETARY_SUPPLEMENT: calcium citrate, DIETARY_SUPPLEMENT: calcium glucarate, DRUG: calcium gluconate, DIETARY_SUPPLEMENT: cholecalciferol, PROCEDURE: assessment of therapy complications, PROCEDURE: musculoskeletal complications management/prevention
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: SUPPORTIVE_CARE
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients must have a histologically confirmed diagnosis of Stage I, II or III breast carcinoma
* Patients must be prescribed letrozole for adjuvant breast cancer treatment
* Prior adjuvant tamoxifen is permitted
* Patients must be postmenopausal; for study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or have a persistently postmenopausal estradiol in the past 6 months without menses, and clinically in menopause at the judgment of the treating physician, or age 60 or older with a prior hysterectomy without oophorectomy, or age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab
Exclusion Criteria:
* Diagnosis of Stage IV breast carcinoma
* Pre-existing myalgias, arthralgias and/or joint stiffness \>= Grade 1, as defined using CTEP CTC identified during baseline physical exam
* Inability to understand or cooperate with study procedures
* Receipt of investigational drug within 30 days before study entry
* Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome
* Unwillingness to give informed consent
* Unwillingness to participate or inability to comply with the protocol for the duration of the study
* Patients with serum calcium \>= 14 mg/dL
* Patients with renal dysfunction defined as glomerular filtration rate \<10ml/min calculated using Cockroft-Gault equation | 36,475 |
Study Objectives
The purpose of this study is to see if dynamic contrast enhanced (DCE) MRI imaging makes it possible to distinguish benign conditions of the breast from malignant tumors and provide better information than can be obtained with regular MRI. DCE MRI uses a new way of collecting and analyzing the images or pictures which provides doctors extra information not available with standard imaging methods. This includes information about the blood vessels of different breast diseases. Pictures produced this way look just like the regular MRI pictures. The DCE MRI adds another imaging sequence (another scan) to the MRI examination ordered by your physician to evaluate your breast lesion, thus increasing the exam time (extra 10 min). The information gained from doing the new test, the DCE MRI, will not be used in your treatment and will not affect the type of care you receive for your breast lesions.
Conditions: Breast Cancer
Intervention / Treatment:
OTHER: perform dynamic contrast enhanced (DCE) MRI
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
· scheduled for breast MRI interventional procedure for a known breast lesion.
Exclusion Criteria:
* patients who would be normally excluded from undergoing an MRI examination patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field.
* patients who are unable to cooperate for an MRI, and/or have known reaction to gadolinium contrast agent. | 16,467 |
Study Objectives
The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.
Conditions: NSCLC
Intervention / Treatment:
DRUG: Sequential Gefitinib With Pemetrexed/Platinum, DRUG: Pemetrexed/Platinum
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. 18\~70 years
2. Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
3. Presence of at least one index lesion measurable by CT scan or MRI
4. Ecog0-1
5. Expected life time longer than 12 weeks
6. Normal laboratory values:
* leucocyte ≥ 4×109/L
* neutrophil ≥ 1.5×109/L
* platelet ≥ 100×109/L
* Hemoglobin ≥ 10g/L
* ALT and
* AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)
7. Signed written informed consent
Exclusion Criteria:
* Patients have used drugs according to protocol
* Patients were allergic to pemetrexed or cisplatin
* Patients received radiotherapy or other biological treatment 4 weeks before the trial
* Uncontrolled hydrothorax or hydropericardium
* neuropathy toxicity ≥ CTC 3
* Severe symptomatic heart disease
* Active upper gastrointestinal ulcer or digestive disfunction
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception | 9,682 |
Study Objectives
The aim of this study is to demonstrate the effectiveness of three and four-staged invitation procedures compared to two-staged procedures by combining pre-notifications and reminders. The RCT will be nested into the Danish colorectal cancer screening programme in the Central Denmark Region including men and women aged 50-74 years. Participants will consecutively be randomized into four arms in a 1:1 ratio. Intervention arm 1 will receive a pre-notification approximately ten days prior to intervention, invitation and one reminder (three-staged intervention), Intervention arm 2 will receive invitation, one reminder after 45 days and a second reminder three months after invitation (three-staged invitation procedure), Intervention arm 3 will receive pre-notification, invitation, reminder after 45 days and reminder after three months (four-staged invitation procedure). Finally, the forth arm will be a control group receiving usual care which invitation and one reminder 45 days after invitation (two-staged invitation procedure). Both pre-notifications and reminders are sent using digital mail.
The main out-come will be participation within 6 months after invitation.
Conditions: Colorectal Neoplasms
Intervention / Treatment:
PROCEDURE: Invitation procedure
Location: Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Invited for colorectal cancer screening
Exclusion Criteria:
- | 9,831 |
Study Objectives
To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have never been treated with an EGFR-TKI
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
DRUG: afatinib
Location: Poland, Austria, Hungary, Portugal, Greece, Israel, Australia, Spain, Czechia, Russian Federation, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria:
Patients with:
* locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)
* Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's testing methodology.
* Adequate organ function, defined as all of the following:
1. Absolute Neutrophil Count (ANC) \> 1500/mm3. (ANC \>1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor).
2. Platelet count \>75,000/mm3
3. Serum creatinine \< 1.5 times of the upper limit of normal
4. Total Bilirubin \< 1.5 times upper limit of (institutional) normal (Patients with Gilbert's syndrome total bilirubin must be \<4 times institutional upper limit of normal).
5. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) \< three times the upper limit of (institutional) normal (ULN) (if related to liver metastases \< five times ULN).
* Eastern Cooperative Oncology Group (ECOG) score between 0 - 2
* written informed consent by patient or guardian prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law.
Exclusion criteria:
Patients who or with:
* prior treatment with an EGFR tyrosine kinase inhibitor (TKI)
* anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted)
* radiotherapy within 14 days prior to drug administration, except as follows:
1. Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
2. Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling.
* previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured.
* known pre-existing interstitial lung disease
* meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had Stable Disease (SD) for at least 4 weeks on stable doses of medication) | 918 |
Study Objectives
Patients aged ≥75 year scheduled for CRC surgery were studied (104 cases) and variables associated with major postoperative complications / mortality were evaluated. The importance of this report is that MPI-score resulted strongly associated with major complications and it was a primary component of an individual prediction model.
Conditions: Colorectal Cancer, Fragility, Elderly
Intervention / Treatment:
PROCEDURE: surgery
Location: Italy
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
All CRC patients aged ≥75 years, who were scheduled for elective surgery and able to express their consent to treatment, were considered.
Exclusion Criteria: emergency surgery; patients aged \<75 years; patients unable to sign informed consent. | 12,492 |
Study Objectives
The purpose of this study is to determine whether the new colonoscope that provides both a traditional and a retrograde view (bending 180 degrees to look behind itself) of the colon can detect more polyps than a standard colonoscope that only provides a forward-facing view. The investigators wish to effectively demonstrate the utility of the new colonoscope (Pentax Retroview Colonoscope) as the objective of this study is to determine polyp and adenoma detection rates in human subjects undergoing colonoscopy for polyp surveillance.
Conditions: Colonoscopy
Intervention / Treatment:
DEVICE: Conventional Pediatric Colonoscope, DEVICE: Short-Turn Radius Colonoscope
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Ability to provide Informed Consent
* Age \> 40
* Surveillance Colonoscopy (History of Adenomas)
Exclusion Criteria:
* Poor or Fair Bowel Prep
* Difficult First Insertion
* Familial Polyposis
* Inflammatory Bowel Disease
* Pregnancy
* Active GI Bleeding
* Prior colonic or rectal resection
* Conserved Sattus
* Colonoscopy less than 3 years ago
* Screening Colonoscopy
* Colonoscopy done to evaluate systems like abdominal pain, diarrhea, constipation, change in bowel habits | 25,098 |
Study Objectives
This is a Phase 1 open-label, multicenter study to evaluate biomarkers for ZN-c5 in subjects with breast cancer
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: ZN-c5
Location: Australia, United States, Bosnia and Herzegovina
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Signed and dated ICF
2. Age ≥ 18 years of age, either gender
3. Females must be postmenopausal as defined by at least one of the following:
1. Age ≥ 60 years;
2. Age \< 60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle stimulating hormone levels within the local laboratory's normal reference range for postmenopausal females;
3. Documented bilateral oophorectomy
4. Histologically or cytologically confirmed diagnosis of adenocarcinoma of the breast
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
6. Adequate organ function defined as follows:
1. Hematologic: Platelets ≥ 100 × 109/L; Hemoglobin ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1.5 × 109/L (without platelet transfusion or any hematopoietic growth factors within previous 7 days of the hematologic laboratory values obtained at the Screening Visit)
2. Hepatic: Aspartate aminotransferase (AST) / Alanine aminotransferase (ALT)
≤ 2.5 × upper limit of normal (ULN); Total or conjugated bilirubin ≤ 1.5 × ULN
3. Renal: Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 60 mL/min
Exclusion Criteria:
1. Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of central venous access, percutaneous feeding tube, or biopsy) within 28 days of the first administration of study drug
2. Treatment with another investigational drug or other intervention within 28 days before the first administration of study drug
3. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medication, including any unresolved nausea, vomiting, or diarrhea that is CTCAE v.5.0 Grade \> 1
4. Myocardial infarction, symptomatic congestive heart failure (New York Heart Association Classification \> Class II), unstable angina, or serious uncontrolled cardiac arrhythmia within the last 6 months of study Day 1
5. Uncontrolled inter-current illness
6. History or evidence of clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion | 10,079 |
Study Objectives
This study is for people with solid tumors cancer for which the standard chemotherapy drugs have not worked. The purpose of this research is to evaluate the side effects of Xeloda (also called capecitabine) in combination with a new anticancer agent called Gleevec (also called imatinib mesylate). Xeloda is an anticancer drug, and can be taken by mouth. The active ingredient is a well-studied cancer drug called 5-FU. Xeloda is approved by the FDA for the treatment of colon cancer. Gleevec is approved in the US for the treatment of patients with a leukemia called CML (increase of white blood cells) after failure of standard therapy. It is also approved by the FDA for patients with Gastrointestinal Stromal Tumors (a rare tumor in the digestive tract).
This study will test how much Gleevec we can safely give with Xeloda. Xeloda will be given at the recommended dose for colorectal cancer and Gleevec will be given in increasing amounts.
Conditions: Colon Cancer, Colorectal Cancer
Intervention / Treatment:
DRUG: capecitabine, imatinib mesylate
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically or cytologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective.
* SWOG performance status 0-2.
* ANC greater than 1500, platelets greater than 100,000.
* Total bilirubin less than 2 x upper limit of normal, or less than 3 x upper limit of normal in patients with liver metastasis. Transaminase (AST and/or ALT) less than 2 x upper limit of normal or less than 3 x upper limit of normal in patients with liver metastasis.
* Serum creatinine less than 1.25 x institutional upper limit of normal.
* Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing.
Exclusion Criteria:
* Patient has received any other investigational agent- within 28 days of first day of study drug dosing.
* Patient with another primary malignancy except if the other primary malignancy is neither currently clinically significant nor requiring active intervention.
* Patient has another severe and/or life-threatening medical disease.
* Patient has an acute or known chronic liver disease (e.g., chronic active hepatitis, cirrhosis).
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
* Patient has received chemotherapy within 4 weeks (6 weeks for nitrosourea, mitomycin-C or any antibody therapy) prior to study entry unless urgent enrollment needed and approved by Novartis.
* Patient had a major surgery within 2 weeks prior to study entry.
* Patients with symptomatic brain metastasis.
* Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (e.g. congestive heart failure, myocardial infarction within 6 months of study)
* Medical, social or psychological factors interfering with compliance.
* Patients under therapeutic coumadin therapy.
* Patients under routine systemic corticosteroid therapy. | 28,372 |
Study Objectives
A program for patients with non small cell lung cancer who may benefit from Iressa, but cannot enter another clinical trial due to them not being eligible, or for whom no trials are available.
Conditions: Carcinoma, Non-small-cell Lung, Metastases, Neoplasm
Intervention / Treatment:
DRUG: ZD1839 (Gefitinib)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria
For inclusion in this trial, patients must fulfill all of the following criteria:
* previous documented histologically or cytologically confirmed non-small cell lung cancer;
* locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV)patients who have received at least one course of standard systemic chemotherapy or radiation therapy or are ineligible for chemotherapy or radiotherapy or are ineligible or not a candidate for enrollment on another ZD1839 trial or who, in the Investigator's opinion, are not medically suitable for chemotherapy.
* age 18 years or older;
* written informed consent to participate in the trial.
Exclusion Criteria
Any of the following will exclude a patient from entering the trial:
* receiving concurrent radiotherapy, chemotherapy, or other systemic anti-cancer medication or any other investigational agent. \* Non-cytotoxic or hormonal therapies for the adjuvant treatment of cancer or for previously treated cancers may be allowed per AstraZeneca permission;
* patients eligible for or previously enrolled on a ZD1839 blinded clinical trial protocol. Patients eligible for or previously enrolled on an open-label or unblinded ZD1839 clinical trial may be considered for acceptance into the Expanded Access Program with AstraZeneca permission;
* having other active malignancies;
* incomplete healing from previous oncologic or other major surgery;
* evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial;
* pregnancy or breast feeding (women of child-bearing potential). | 17,054 |
Study Objectives
RATIONALE: Estrogen may cause the growth of prostate cancer cells. Hormone therapy using fulvestrant may fight prostate cancer by blocking the use of estrogen by the tumor cells.
PURPOSE: This phase II trial is studying how well fulvestrant works in treating patients with advanced prostate cancer.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: fulvestrant
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Advanced disease
* Must have androgen-independent prostate cancer meeting the following criteria:
* Evidence of rising prostate-specific antigen (PSA) level and absolute value ≥ 5 ng/mL based on 2 measurements taken ≥ 2 weeks apart (measurements must be done after androgen deprivation \[orchiectomy or luteinizing hormone-release hormone (LHRH) analogue\] and antiandrogen withdrawal)
* Rising PSA required for ≥ 28 days after antiandrogen or progestational therapy for prostate cancer (≥ 42 days after bicalutamide or nilutamide)
* Testosterone \< 50 ng/mL (unless surgically castrated)
* Measurable or evaluable disease
* PSA elevation constitutes evaluable disease
PATIENT CHARACTERISTICS:
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* WBC \> 3,000/mm\^3
* Neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 8 g/dL (transfusion or epoetin alfa allowed)
* No bleeding diathesis (e.g., disseminated intravascular coagulation or clotting factor deficiency)
Hepatic
* Bilirubin normal
* Gilbert's disease with bilirubin ≤ 3 times upper limit of normal (ULN) allowed in the absence of other etiology (e.g., hemolysis-reticulocyte count \< 5%) and liver function tests normal
* SGOT and/or SGPT ≤ 2 times ULN
* INR \< 1.6
Renal
* Creatinine \< 2.5 mg/dL
Cardiovascular
* No unstable cardiac disease requiring medication
* No new onset crescendo or rest angina
* Stable exertional angina allowed
Other
* Fertile patients must use effective barrier contraception during and for 3 months after completion of study treatment
* No other active malignancy within the past 2 years except nonmelanoma skin cancer or superficial bladder cancer
* No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures
* No other serious illness or medical condition
* No active infection
* No known hypersensitivity to active or inactive excipients of fulvestrant (e.g., castor oil or mannitol)
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Prior retinoids, vaccines, and cytokines are not considered cytotoxic and are allowed
Chemotherapy
* No more than 1 prior cytotoxic chemotherapy regimen
* More than 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)
* No concurrent chemotherapy
Endocrine therapy
* See Disease Characteristics
* Prior glucocorticoids, antiandrogens, progestational agents, estrogens, and LHRH analogues are not considered cytotoxic and are allowed
* At least 4 weeks since prior flutamide (6 weeks for bicalutamide or nilutamide)
* Concurrent megestrol acetate allowed at a stable dose of ≤ 40 mg/day
* Concurrent androgen deprivation using LHRH analogues allowed but must continue during study treatment or orchiectomy is required to maintain castrate levels of testosterone
Radiotherapy
* More than 3 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* See Disease Characteristics
* See Endocrine therapy
Other
* Recovered from all prior therapy
* Prior cholecalciferol analogues, ketoconazole, aminoglutethimide, peroxisome-proliferation-activated receptor-gamma agonists or antagonists, or PC-SPES are not considered cytotoxic and are allowed
* No prior long-term anticoagulation therapy (antiplatelet therapy allowed)
* More than 4 weeks since prior investigational drugs
* No other concurrent anticancer therapy (e.g., PC-SPES)
* No concurrent bisphosphonates unless receiving a stable dose at study entry
* No concurrent therapy that may alter androgen metabolism or androgen levels
* No concurrent full anticoagulation | 43,532 |
Study Objectives
The combination of oxaliplatin, 5-FU, leucovorin, and capecitabine is hypothesized to retain and potentially improve upon the activity of the FOLFOX regimens. Additionally, the use of an oral rather than an infusional 5-fu regimen represents a clear advantage in terms of both patient convenience and lack of associated catheter-related complications.
Conditions: Metastatic Colorectal Cancer
Intervention / Treatment:
DRUG: chemotherapy (capecitabine, oxaliplatin, 5-FU, leucovorin)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* no prior treatment for metastatic disease
* PS 0-2
* measurable disease
Exclusion Criteria:
* neuropathy \> or equal to grade 2
* concomitant radiation therapy or other systemic cancer therapies
* brain mets | 10,850 |
Study Objectives
This study is a retrospective real-world study. In this study, we plan to collect the clinical data of LASCCHN patients who received chemoradiotherapy combined with or without nimotuzumab .
Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma
Intervention / Treatment:
DRUG: nimotuzumab
Location: China
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Age ≥18 years old, no gender limitation;
* Histopathologically or cytologically proved to be phase III-IVb of head and neck squamous cell carcinomas (including oral cancer, oropharynx cancer, hypopharynx cancer, larynx cancer, but except for nasopharyngeal carcinoma).
* Patients who received chemoradiotherapy combined with or without nimotuzumab from January 2015 to December 2018;
* Patients in the study group received nimotuzumab, while patients in the control group did not receive nimotuzumab. And patients in the control group were collected 3 times as many cases as the study group in each center. If the number of patients in the control group were less than 3 times of the study group, all cases were collected.
Exclusion Criteria:
* Complicated with primary malignancies other than head and neck tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
* Patients received other targeted therapy, immunotherapy, or Traditional Chinese medicine with anti-tumor effect, along with the application of nimotuzumab;
* Lack of critical evaluation information. | 16,510 |
Study Objectives
This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.
Conditions: Stage IV Nasopharyngeal Carcinoma
Intervention / Treatment:
DRUG: cisplatin and 5-Fu combined with nimotuzumab
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologic diagnosis of nasopharyngeal carcinoma
* Distance metastasis at least 6 months after radical treatment
* Not suitable for local treatment, e.g. surgery, TACE
* At least one measurable lesion
* Estimate survival \>3months
* Range from 18～70 years old
* PS 0\~1
* WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
* ALT or AST \< 2.5×ULN、bilirubin \< 1.5×ULN
* 0Serum creatinine \< 1.5×ULN
Exclusion Criteria:
* Central nervous system metastases
* Suitable for local treatment
* Second malignancy within 5 years
* Precious therapy with an investigational agent
* Uncontrolled seizure disorder or other serious neurologic disease
* ≥ Grade Ш allergic reaction to any drug including in this study
* Clinically significant cardiac or respiratory disease
* Creatinine clearance \< 30ml/min
* Drug or alcohol addition
* Do not have full capacity for civil acts
* Severe complication, active infection
* Concurrent immunotherapy or hormone therapy for other diseases
* Pregnancy or lactation | 27,714 |
Study Objectives
Anatomical resection with systematic lymph-node dissection is currently the standard of care for the treatment of early stage non-small cell lung cancer. The use of minimally invasive approaches has increased greatly over the last two decades \[either video-assisted thoracoscopic surgery (VATS) or robotic-assisted thoracoscopic surgery (RATS)\], as they provide the patient with better outcomes than open thoracotomy. Minimally invasive VATS lobectomy for a standard case is generally a straightforward procedure for a well-trained surgical team, although concomitant preoperative pathologies or intraoperative findings/adverse events may result in technical difficulties, leading to intraoperative conversion, commonly by thoracotomy.
The investigators aimed to assess long-term outcomes in a consecutive cohort of patients treated by anatomical pulmonary resection either using VATS, VATS requiring intraoperative conversion to thoracotomy, or upfront open thoracotomy for lung-cancer surgery.
Conditions: Video-assisted Thoracoscopic Surgery, Lung Cancer, Lobectomy, Survival, Surgery
Intervention / Treatment:
PROCEDURE: anatomical resection
Location: France
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* All consecutive patients treated by anatomical lobar pulmonary resection (lobectomy, bilobectomy) or anatomical sublobar pulmonary resection (segmentectomy) for non-small cell lung cancer (NSCLC), either by VATS (eventually with intraoperative conversion) or upfront thoracotomy.
Exclusion Criteria:
* patients with non-anatomical pulmonary resection (wedge resection)
* patients with a histology other than NSCLC (benign or metastatic from another primitive cancer), stage IV NSCLC disease,
* patients with multiple primary NSCLC (synchronous or metachronous)
* patients with incomplete resection (R+)
* patient for whom a VATS approach was never considered | 4,410 |
Study Objectives
This multi-center, multi-arm trial is evaluating the safety and efficacy of tagraxofusp, a CD123-targeted therapy, in patients with either chronic myelomonocytic leukemia (CMML) or myelofibrosis (MF). There are two CMML cohorts, one enrolling patients with CMML (CMML-1 or CMML-2) who are refractory/resistant or intolerant to hypomethylating agents (HMA), hydroxyurea (HU), or intensive chemotherapy; and one enrolling treatment-naive patients with CMML (CMML-1 or CMML-2) with molecular features associated with poor prognosis. The MF cohort will enroll patients who are resistant/refractory or intolerant to approved JAK therapy (JAK1/JAK2 or JAK2).
Conditions: Myelofibrosis, Chronic Myelomonocytic Leukemia
Intervention / Treatment:
DRUG: SL-401
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Abbreviated Inclusion Criteria:
All Patients (Stages 2 and 3A):
1. The patient is ≥18 years old.
2. The patient has a life expectancy of \>6 months.
3. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
4. The patient has adequate baseline organ function, including cardiac, renal, and hepatic function:
* Left ventricular ejection fraction (LVEF) ≥ institutional lower limit of normal as measured by multigated acquisition scan (MUGA) or 2-dimensional (2-D) echocardiogram (ECHO) within 28 days prior to start of therapy and no clinically significant abnormalities on a 12-lead electrocardiogram (ECG)
* Serum creatinine ≤1.5 mg/dL
* Serum albumin ≥3.2 g/dL (or ≥32 g/L) in the absence of receipt of (IV) albumin within the previous 72 hours
* Bilirubin ≤1.5 mg/dL
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN)
* Creatine phosphokinase (CPK) ≤2.5 times the ULN
* Absolute neutrophil count (ANC) ≥0.5 × 10⁹/L
Additional Abbreviated Inclusion Criteria Specific to Patients with MF (Stage 2):
1. Patient meets the 2016 WHO diagnostic criteria for MF and has an IPSS/DIPSS/DIPSS-plus intermediate-2 or high-risk disease. Patients with IPSS/DIPSS/DIPSS-plus low or intermediate-1 risk disease who have at least one of the following symptoms are also eligible: MF-related anemia (Hb \<10 g/dL), splenomegaly (palpable size \>10 cm), leukocytosis (WBC \>25 × 10⁹/L), marked thrombocytosis (platelet count \>1000 × 10⁹/L), or constitutional symptoms (weight loss \>10%, during prior 6 months or fever \[\>37.5ºC or drenching night sweats for \>6 weeks\]), as recommended by the ELN/IWG 2018 criteria.
2. Patient is approved JAK therapy (JAK1/JAK2 or JAK2) resistant/refractory or intolerant, in accordance with the ELN/IWG 2018 criteria, and at least 4 weeks have elapsed between the last dose of any MF-directed drug treatments; excluding HU, and study enrollment (first dose). HU can be continued until 2 weeks prior to study enrollment.
3. Patient is not eligible for an immediate allo-SCT.
Additional Abbreviated Inclusion Criteria Specific to Patients with CMML (Stage 3A):
1. Patient has a 2016 WHO-defined diagnosis of CMML (persistent monocytosis ≥1 × 10⁹/L for at least 3 months, with other causes excluded, and monocytes ≥10% of WBC in peripheral blood, no criteria and no previous history of CML, ET, PV, and acute promyelocytic leukemia; if eosinophilic, neither PDGFRA, PDGFRB, FGFR1 rearrangements nor PCM1-JAK2 translocation; \<20% blasts in peripheral blood and bone marrow aspirate; \>1 following criteria - dysplasia in \>1 myeloid lineage, acquired clonal cytogenetic or molecular abnormality in hematopoietic cells).
2. Patient has 2016 WHO-defined CMML-1 (2-4% blasts in peripheral blood and/or 5-9% blasts in bone marrow) and CMML-2 (5-19% blasts in peripheral blood and/or 10-19% blasts in bone marrow, and/or presence of Auer rods).
3. Patient is refractory/resistant/intolerant to HMAs, or HU, or intensive chemotherapy OR patient is classified as high-risk based on the presence of morphological features, as described by the 2016 WHO prognostic system, and the clinical and molecular features described in molecularly-integrated prognostic systems, such as the GFM, MMM, and the CMML specific prognostic model (CPSS-Mol), and thus is not expected to benefit from HMAs.
4. Patient is ineligible for an immediate allo-SCT.
Abbreviated Exclusion Criteria:
All Patients (Stages 2 and 3A):
1. Persistent clinically significant toxicities Grade ≥2 from previous therapies not readily controlled by supportive measures (excluding alopecia, nausea, and fatigue).
2. Treatment with any disease-related therapy, including radiation therapy or investigational agent, within 14 days of study entry.
3. Allogeneic SCT within 3 months of study entry.
4. Previous treatment with tagraxofusp or known hypersensitivity to any components of the drug product.
5. Active malignancy and/or cancer history (excluding myeloproliferative disorders and concomitant myeloid malignancies as specified in the inclusion criteria) that can confound the assessment of the study endpoints. Patients with a past cancer history (within 2 years of entry) and/or ongoing active malignancy or substantial potential for recurrence must be discussed with the Sponsor before study entry. Patients with the following neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including superficial bladder cancer), cervical intraepithelial neoplasia, or organ-confined prostate cancer with no evidence of progressive disease.
6. Clinically significant cardiovascular disease, pulmonary disease, or known active or suspected disease involvement of the central nervous system (CNS).
7. Receiving immunosuppressive therapy, with the exception of corticosteroids as specified in the inclusion criteria and tacrolimus, for treatment or prophylaxis of graft-versus-host disease (GVHD).
8. Uncontrolled intercurrent illness.
9. Patient is pregnant or breast feeding.
10. Patient has known human immunodeficiency virus (HIV), Hepatitis B or Hepatitis C.
11. Patient is oxygen-dependent.
Additional Exclusion Criteria Specific to Patients with MF and CMML (Stages 2 and 3A) apply. | 39,052 |
Study Objectives
The main objective of the study is to validate a methodology with Psychometric tool to measure levels of patients social fragility.
This tool will be dematerialized on a tablet. The answers will be then processed by a decision support algorithm, which automatically send an alert to detection of social fragility of the patient to the nurse navigators.
Conditions: Cancer
Intervention / Treatment:
OTHER: Questionnaire and interview
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* All new patients enter ICLN for a diagnosis of cancer
* Patients who can read French or patients who can not read French, but accepting the translation by a close friend or family
* Patient having signed a free and informed consent
Exclusion Criteria:
* Refusal of participation, major patients protected under guardianship.
* Patient can not read French without possibility of translation by a close friend or family | 37,281 |
Study Objectives
This phase II trial is studying how well combination chemotherapy, radiation therapy, and/or surgery work in treating patients with high-risk kidney tumors. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Conditions: Childhood Renal Cell Carcinoma, Clear Cell Renal Cell Carcinoma, Clear Cell Sarcoma of the Kidney, Papillary Renal Cell Carcinoma, Rhabdoid Tumor of the Kidney, Stage I Renal Cell Cancer, Stage I Renal Wilms Tumor, Stage II Renal Cell Cancer, Stage II Renal Wilms Tumor, Stage III Renal Cell Cancer, Stage III Renal Wilms Tumor, Stage IV Renal Cell Cancer, Stage IV Renal Wilms Tumor
Intervention / Treatment:
DRUG: Doxorubicin Hydrochloride, DRUG: Irinotecan Hydrochloride, PROCEDURE: Conventional Surgery, DRUG: Cyclophosphamide, DRUG: Etoposide, DRUG: Carboplatin, BIOLOGICAL: Dactinomycin, DRUG: Vincristine Sulfate, RADIATION: Radiation Therapy, OTHER: Laboratory Biomarker Analysis
Location: New Zealand, United States, Canada, Australia, Puerto Rico
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Newly diagnosed disease of 1 of the following histologic types:
* Focal anaplastic Wilms' tumor
* Diffuse anaplastic Wilms' tumor
* Clear cell sarcoma of the kidney
* Malignant rhabdoid tumor (renal or extrarenal)
* Renal cell carcinoma
* Clear cell
* Papillary
* Renal medullary
* Oncocytoid
* Sarcomatoid
* Chromophobe
* Translocation
* Collecting duct
* Carcinoma associated with neuroblastoma
* Renal cell carcinoma unclassified
* Specimens/materials must be submitted for central review by Day 7
* Patients must begin protocol therapy on AREN0321 by Day 14 after surgery or biopsy (surgery/biopsy is Day 0), unless medically contraindicated
* Karnofsky performance status (PS) must be \>= 50 for patients \> 16 years if age and Lansky PS must be \>= 50 for patients =\< 16 years of age
* Patients must not have received systemic chemotherapy or radiation therapy prior to treatment on this study UNLESS they were enrolled on the AREN0532 or AREN0533 studies and received prenephrectomy chemotherapy for what was originally presumed to be favorable histology Wilms tumor; additionally, patients with pediatric RCC who previously received chemotherapy for another type of malignancy (not the RCC) or non-malignant condition may enroll on the study
* Total bilirubin =\< 1.5 times upper limit of normal (ULN) for age
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\] or serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase \[ ALT\]) \< 2.5 times ULN for age
* Shortening fraction of \>= 27% by echocardiogram OR ejection fraction of \>= 50% by radionuclide angiogram
* Female patients of childbearing age must have a negative pregnancy test
* Female patients who are lactating must agree to stop breast-feeding
* Sexually active patients of childbearing potential must agree to use effective contraception
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met | 41,783 |
Study Objectives
Colorectal cancer (CRC) is the most common cancer for men and the second most common for women. Several studies have shown that gut microbiome may play a role in triggering intestinal inflammation that leads to the development of CRC. Gut microbiome is the collection of microorganisms that inhabit the gut. Therefore, manipulation of the gut microbiome via administration of probiotics may potentially improve the health and nutritional status in patients with CRC. The aims of this study are to investigate the role of probiotic functional foods in reducing CRC-related inflammatory markers and symptom alleviation.Participants will be needed to complete an information details form which includes information on age, medical history, background details and diet. Participants are required to consume the investigational product twice daily for six months. Blood samples will be collected prior to surgery and at 6th months post product consumption. These blood samples will be processed and analysed.
Conditions: Colorectal Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Probiotic, OTHER: Placebo
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* 18 years and above.
* Diagnosed with colorectal cancer
* Planned for colorectal resection
Exclusion Criteria:
* Received antibiotics 2 weeks prior to recruitment
* Consumed pro/pre/symbiotic product 2 weeks prior to recruitment,
* Patients with recurrent colorectal cancer
* Advanced metastasis
* Nursing or pregnant women | 44,079 |
Study Objectives
The objectives of this study are to assess the safety, tolerability, pharmacokinetics and efficacy of VAL401 in the treatment of patients with locally advanced or metastatic non-small cell lung adenocarcinoma.
Conditions: Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
Intervention / Treatment:
DRUG: VAL401
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Pathologically confirmed diagnosis of Stage IIIB or Stage IV adenocarcinoma of the lung. Patients with mixed histology will be eligible if adenocarcinoma is the predominant histology.
* Measurable disease according to RECIST version 1.1.
* Prior chemotherapy for relapsed or metastatic non small cell lung cancer.
* Life expectancy of at least 3 months.
* Negative human chorionic gonadotropin (hCG) test in women of childbearing potential (defined as women ≤ 50 years of age or history of amenorrhea for ≤ 12 months prior to study screening). Sexually active male and female patients of childbearing potential must agree to use an effective method of birth control e.g. barrier methods with spermicides, oral or parenteral contraceptives and/or intrauterine devices, during the entire duration of the study and for 1 month after the final administration of VAL401. Note that female patients may be surgically sterile (with appropriate documentation in the patient's medical records).
* Ability to give written, informed consent prior to any study-specific screening procedures with the understanding that the consent may be withdrawn by the patient at any time without prejudice.
* Patient is capable of understanding the protocol requirements, is willing and able to comply with the study protocol procedures, and has signed the informed consent document.
Exclusion Criteria:
* Radiotherapy or surgery (other than biopsy) within 4 weeks prior to Cycle 1 Day 1.
* Any chemotherapy regimens (including investigational agents) with delayed toxicity with 6 weeks of Cycle 1 Day 1, or received any chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks prior to Cycle 1 Day 1. Palliative treatment regimens, and other concomitant drugs regimens are permitted with stable toxicity, and recording of all concomitant medications (including herbal).
* Pregnant or lactating female patients.
* Active hepatitis B or C or other active liver disease (other than malignancy).
* Any active, clinically significant, viral, bacterial, or systemic fungal infection within 2 weeks prior to Cycle 1 Day 1; other than cytomegalovirus which may be present providing any required concomitant anti-viral treatment is recorded appropriately.
* Known human immunodeficiency virus positivity.
* History of clinically significant cardiac condition, including ischemic cardiac event, myocardial infarction or unstable cardiac disease with 3 months prior to Cycle 1 Day 1.
* Active brain metastases (defined as stable for \<4 weeks and/or symptomatic and/or requiring treatment with anticonvulsants or steroids and/or leptomeningeal disease).
* Any known contraindications to Risperidone or patients who would not be eligible to receive the treatment as defined in the Special Warnings and Precautions section of the local label for Risperidone.
* Any medical history that in the Investigator's opinion would jeopardise compliance with the protocol. | 18,611 |
Study Objectives
Today about 80% childhood cancer patients become long-time survivors. In spite of the high cure rates the diagnosis cancer is associated with a variety of disease and treatment-related psychological and physical impairments mostly present into adulthood. So the attention has to focus on the improvement of these problems such as motor limitation, dysfunction of the cardiovascular system, reduced muscle strength, overweight, osteoporosis and diminished quality of life (Qol). Although exercisel intervention studies in this field are generally scarce, the results of these studies are promising. Up to now studies during the acute phase of treatment are missing almost completely. The aim of this feasibility study is to evaluate the potential benefits of a modular exercise intervention program for childhood cancer patients startunf in parallel with treatment and longlasting for one year. Across two years cancer patients of the Children's Hospital of the University Clinic of Heidelberg aged 5-21 years, free of any contraindications for physical activity will be recruited. All participants are asked to complete a physical assessment battery (strength, endurance and balance capacity, posture control, functional mobility, range of motion) and additionally two questionnaires concerning Qol and motivation, at baseline and every three months following one year
Conditions: Childhood Cancer
Intervention / Treatment:
BEHAVIORAL: Multimodal Exercise Intervention
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: NON_RANDOMIZED
Interventional Model: FACTORIAL
Masking: NONE | Inclusion Criteria:
* pediatric cancer diagnosis (primary leukemia, brain tumors and bone tumors
* date of diagnosis not longer than 8 weeks ago
Exclusion Criteria:
* severe cardiac impairment
* bone metastasis inducing skeletal fragility
* other orthopedic diseases or any other circumstance that would impede ability to give informed consent or adherence to study requirements. | 22,665 |
Study Objectives
It is Randomized Controlled Trial, in which investigators will estimate the impact of the use of immunonutrition support compared to standard nutritional support in the preoperative period in patients with colorectal cancer.
Conditions: Colon Cancer, Nutrition Aspect of Cancer
Intervention / Treatment:
DIETARY_SUPPLEMENT: Immunonutrition, DIETARY_SUPPLEMENT: Standard Oral Nutritional Support
Location: Poland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Diagnosis of colon cancer during preoperative colonoscopy confirmed by histopathological examination.
Exclusion Criteria:
* emergency/urgent operation
* active infection
* inflammatory bowel diseases in history
* other systemic immune disorders
* the necessity of preoperative neoadjuvant treatment (radiotherapy or chemotherapy)
* metastatic disease, or local infiltration of cancer which was described as T4 stage in preoperative CT scan
* patients who were not able to intake at least 85% of administrated ONS doses | 27,692 |
Study Objectives
This is a prevalence study evaluating lower urinary tract, prolapse, bowel, and sexual symptoms in women with a colorectal disorder who are planning to undergo surgery.
The purpose of this study is to identify the number of women who complain of lower urinary tract and bowel problems, including frequency, urgency, urinary incontinence, fecal incontinence, pain with intercourse, and other sexual problems prior to undergoing surgical management for a colorectal disorder.
Conditions: Lower Urinary Tract Symptoms, Colorectal Disorders
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Female subjects with a diagnosis of a colorectal disorder, including rectal prolapse, inflammatory bowel disease such as Crohn's disease, Ulcerative Colitis, and colorectal malignancies planning to undergo surgery
* Females have English as a primary language
Exclusion Criteria:
* Subjects less than 18 years of age
* Subjects unable to give informed consent or complete the validated questionnaires | 12,200 |
Study Objectives
This is an open-label Phase 1b/2 multicenter study of rebastinib (DCC-2036) in combination with paclitaxel designed to evaluate the safety, tolerability, and pharmacokinetics (PK) in patients with advanced or metastatic solid tumors.
Conditions: Locally Advanced or Metastatic Solid Tumor
Intervention / Treatment:
DRUG: rebastinib, DRUG: Paclitaxel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion Criteria:
1. Male or female patients ≥18 years of age at the time of informed consent.
2. Part 1 Histologically confirmed diagnosis of a locally advanced or metastatic solid tumor for which paclitaxel is considered appropriate treatment.
3. Part 2
* Triple-negative and Stage IV inflammatory breast cancer.
* Recurrent ovarian cancer.
* Recurrent, metastatic or high-risk endometrial cancer.
* Advanced (stage III or IV), or recurrent gynecological carcinosarcoma
* Homologous or heterologous type carcinosarcoma (malignant mixed Mullerian tumor \[MMMT\] allowed
4. ECOG PS of ≤2.
5. Able to provide an archival tumor tissue sample
6. Adequate organ function and bone marrow reserve
7. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment.
8. Patient must provide signed consent to participate in the study and is willing to comply with study-specific procedures.
Exclusion Criteria:
1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.
2. Not recovered from prior-treatment toxicities to Grade ≤1.
3. Peripheral neuropathy of any etiology \>Grade 1.
4. Concurrent malignancy.
5. Known active CNS metastases.
6. Use of systemic corticosteroids.
7. Known retinal neovascularization, macular edema or macular degeneration.
8. History or presence of clinically relevant cardiovascular abnormalities.
9. QTcF \>450 ms in males or \>470 ms in females.
10. Left ventricular ejection fraction (LVEF) \<50% at screening.
11. Arterial thrombotic or embolic events.
12. Venous thrombotic event.
13. Active infection ≥Grade 3.
14. HIV or HCV infection only if taking medications excluded per protocol, active HBV, or active HCV infection.
15. Use of proton pump inhibitors.
16. If female, the patient is pregnant or lactating.
17. Major surgery 4 weeks prior to the first dose of study drug
18. Malabsorption syndrome or other illness which could affect oral absorption.
19. Known allergy or hypersensitivity to any component of rebastinib or any of its excipients.
20. Any other clinically significant comorbidities | 41,329 |
Study Objectives
Women with polycystic ovary syndrome (PCOS) appear to have an increased frequency of sleep problems. The aim of this study was to explore the effect of auricular point acupressure (APA) pressure on sleep quality in women with PCOS.
Conditions: Polycystic Ovary Syndrome
Intervention / Treatment:
OTHER: Auricular point acupressure (APA)
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Subjects were included if they
1. were aged between 18-40 years old;
2. met the clinical diagnostic criteria of Western and Chinese medicine for PCOS with sleep disorders;
3. were evaluated by the Pittsburgh Sleep Quality Index Scale (PSQI) and had a score ≥ 7 points;
4. did not participate in other clinical trials.
Subjects were excluded if they
1. had a serious organic condition such as cardiovascular, cerebrovascular, liver, or kidney disease;
2. had acute gynecological inflammation, gynecological tumors, or reproductive system malformations;
3. had severe anxiety, depression, or other mental illnesses;
4. were pregnant;
5. had used sleeping and sedative drugs in the past month;
6. were allergic to ear point tape;
7. had local rupture of the skin at the selected ear point;
8. refused to fill out questionnaires and sign informed consent forms. | 5,523 |
Study Objectives
This trial is to study the efficacy of nab-PC vs. GC and evaluate toxicity of nab-PC in advanced squamous cell cancer of lung. The correlation between the efficacy of nab-PC and some biomarkers is also to be evaluated.
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
DRUG: Albumin paclitaxel plus carboplatin, DRUG: Gemcitabine plus carboplatin
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Previously untreated, histological documented stage IIIB (not amenable for radical regional therapy) or stage IV squamous cell carcinoma of lung. At least one measurable lesion as defined by RECIST criteria.
* At least 18 years of age.
* ECOG PS 0\~1
* Patients have no previously malignant tumor history except cured cervical carcinoma in situ, basal cell carcinoma or superficial bladder cancer. Patients are also eligible if they have received a chemotherapy regimen as neoadjuvant or adjuvant chemotherapy and the disease recurred over 12 months since the finishing of neoadjuvant or adjuvant chemotherapy.
* neutrophil ≥ 1.5 x 109 /L, Hemoglobin \> 90 g/L, Platelet count \> 100x109/L.
* Total bilirubin ≤ 1.5 x upper limit of normal. ALT and AST \< 2.5 x upper limit of normal without liver metastasis, ALT and AST \< 5 x upper limit of normal with liver metastasis. Serum creatinine \< 1.5 x upper limit of normal.
* Urine pregnancy test is negative for woman.
* Estimated life expectancy is at least 3 months.
* Patient comply with the clinical trial protocal.
* Informed consent must be signed.
Exclusion Criteria:
* Patients who are currently undergoing other anti-tumor therapy.
* Patients who was enrolled in any other clinical trial within 4 weeks of study entry.
* Any physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of any study medication or render the subject at high risk from treatment.
* Central nervous system (CNS) tumor or metastatic tumor.
* Serious mental disorder.
* Serious dysgnosia.
* Other serious comorbidity.
* Alcohol or drug dependence.
* Previously allergic to drugs used in the study. | 26,307 |
Study Objectives
Tumors are heterogeneous with varying response to chemotherapeutic agents. We hypothesize that tumors that are sensitive to a particular chemotherapeutic agent have a distinctive tumor protein profile compared to those that are resistant. We further hypothesize that since tumor is continuously perfused by serum, serum protein profile can be used as a surrogate marker of tumor protein profile. The primary objective of this study is to identify a serum protein profile that predicts gemcitabine/carboplatin sensitivity or resistance in breast cancer patients with prior exposure to anthracyclines and taxanes. Secondary objectives are to establish the serum protein profile of breast cancer patients who have had prior exposure to anthracyclines and taxanes, and to study the pharmacogenetics of gemcitabine toxicity by correlating germline genotype of transporters and drug metabolizing enzymes with plasma and intracellular gemcitabine pharmacokinetics.
Conditions: Metastatic Breast Cancer
Intervention / Treatment:
DRUG: gemcitabine, carboplatin
Location: Singapore
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Female, age \>= 18 years.
* Histologic or cytologic diagnosis of breast carcinoma.
* Stage IV breast cancer with prior exposure to anthracyclines and taxanes, either in the neoadjuvant, adjuvant or metastatic setting.
* Presence of at least one uni-dimensionally measurable, non-CNS indicator lesion defined by radiologic study or physical examination
* For patients with previous radiotherapy, the indicator lesion(s) must not be within the previous radiation field. The last dose of radiotherapy should be at least 3 weeks prior to study entry. The total radiotherapy received should not be more than 30% of the bone marrow.
* Karnofsky performance status of 70 or higher.
* Estimated life expectancy of at least 12 weeks.
* Adequate organ function including the following:
- Bone marrow: White blood cells (WBC) \>= 3.5 x 109/L Absolute neutrophil (segmented and bands) count (ANC) \>= 1.5 x 109/L Platelets \>= 100 x 109/L Haemoglobin \>= 9g/dL
- Hepatic: Bilirubin \<= 1.5 x upper limit of normal (ULN), ALT or AST \<= 2.5x ULN, (or \<5 X with liver metastases) Alkaline phosphatase \<= 2.5x ULN.
- Renal: Creatinine clearance \>30ml/minute, based on the Cockcroft formula
* Signed informed consent from patient or legal representative.
* Patients with reproductive potential must use an approved contraceptive method if appropriate (eg, intrauterine device, birth control pills, or barrier device) during and for three months after the study. Females with childbearing potential must have a negative serum pregnancy test within 7 days prior to study enrollment.
Exclusion Criteria:
* Treatment within the last 30 days with any investigational drug.
* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
* Pregnancy.
* Breast feeding.
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Symptomatic brain metastasis. | 5,638 |
Study Objectives
RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for their growth.
PURPOSE: Phase I trial to study the effectiveness of BCX-1777 in treating patients who have refractory cancer.
Conditions: Cancer
Intervention / Treatment:
DRUG: forodesine hydrochloride
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following:
* Hematologic malignancy that is refractory to at least 1 prior curative treatment
* Non-hematologic tumor that is refractory to at least 2 prior therapies, with or without measurable disease, including the following:
* Gastrointestinal adenocarcinoma of 1 of the following sites:
* Pancreatic
* Biliary
* Gastric
* Colorectal
* Esophageal
* Melanoma
* Ovarian cancer
* Astrocytoma brain tumor
* Not immediately eligible for any other treatment that would be potentially curative or life-prolonging, in the opinion of the investigator
* Patients who may be candidates for future bone marrow transplantation are eligible
* No brain metastases (other than astrocytomas)
* No clinically significant pleural effusion
* No complete tumor obstruction (e.g., bronchus, ureter, or bowel)
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 50-100%
Life expectancy
* Not specified
Hematopoietic
* WBC at least 3,500/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count greater than 50,000/mm\^3
* Hematocrit stable without the need for transfusion (epoetin alfa support allowed)
Hepatic
* Bilirubin less than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome)
* SGOT and SGPT less than 2 times ULN
* No active hepatitis B or C
Renal
* Creatinine clearance at least 50 mL/min
Cardiovascular
* No American Heart Association class III or IV cardiac disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No active systemic infection requiring IV antibiotics
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Concurrent corticosteroids allowed provided the patient is on a stable regimen
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Recovered from prior therapy
* No grade 2-4 toxicity
* More than 3 weeks since prior antineoplastic and/or investigational therapy
* No other concurrent systemic antineoplastic or investigational therapy | 18,911 |
Study Objectives
We hypothesize that combination of tegafur/uracil(UFUR) and thalidomide, both of which have been shown to be active in some HCC patients,may be a highly useful regimen for the treatment of advanced HCC. There are several rationales underlying this combination. First, anti-angiogenesis therapy may improve the efficacy of chemotherapy by normalizing the abnormal vasculature in tumors, and thus improving the delivery of chemotherapeutic agents to the tumor cells. Second, chemotherapeutic drugs given in a low-dose, un interrupted, and protracted way can induce anti-tumor effect through the anti-angiogenesis activity (so-called"metronomic chemotherapy"). The efficacy of metronomic chemotherapy can be suppressed by VEGF/VEGFR signaling pathways and thus can bo further potentiated by agents blocking those survival signals of endothelial cell. In this regard, tegafur/uracil appears to be a good candidate for metronomic chemotherapy because tegafur/uracil and its metabolites bave already been shown to inhibit angiogenesis in several pre-clinical models.
Conditions: Hepatocellular Carcinoma
Intervention / Treatment:
DRUG: Thalidomide, DRUG: Tegafur/Uracil
Location: Taiwan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically confirmed HCC or HBC/HCV carrier with hepatic tumor of α-FP\>400 Stage IV dis. By AJCC KPS\>70% Age\>18 Liver function reserves:Child-Pugh Class A, ALT\<5xUNL, Bil-T\<1.5xUNL WBC\>4000 or ANC\>1500, PLT\>75K, Cr\<1.5xUNL Previous local therapy completed 6wks
Exclusion Criteria:
* Concurrent corticosteroids Previous exposure to C/T, Thalidomide CNS metastasis Concomitant illness: active infection, \>NCIG2 neuropathy, Hx of seizures Organ transplantation | 40,425 |
Study Objectives
The aims of this protocol are:
1. To study the safety and tolerability of the combination of etanercept and gemcitabine in patients with advanced pancreatic cancer:
2. To estimate the anti-tumor effect as measured by the proportion of patients free of disease-progression at six months after treatment initiation.
Conditions: Pancreatic Neoplasms, Adenocarcinoma
Intervention / Treatment:
DRUG: Gemcitabine, DRUG: Etanercept
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Must have pathological diagnosis recurring or metastatic Pancreatic Adenocarcinoma
* No prior chemotherapy, immunology treatments or hormonal treatments
* Measurable disease
* Must be \>18 years old
* ONLY CONTROL ARM IS OPEN TO ACCRUAL
Inclusion Criteria:
* Pregnant and nursing mothers.
* Psychiatric disorders that would interfere with consent ability.
* Patients with known brain or leptomeningeal disease.
* Patients with history of myocardial infarction with in six previous months.
* Any concurrent illness that would constitute a hazard to participation in study.
* Known sensitivity to gemcitabine or etanercept.
* Prior treatment with etanercept. | 6,742 |
Study Objectives
This is a clinical trial examining the safety, pharmacokinetics, pharmacodynamics and efficacy of IV NPI-0052 (a proteasome inhibitor) in combination with oral vorinostat (Zolinza; a HDAC inhibitor) in patients with non-small cell lung cancer, pancreatic cancer, melanoma or lymphoma. Proteasome inhibitors block the breakdown of proteins by cells and HDAC inhibitors block modification of proteins regulating gene expression in cells. Both of these actions preferentially affect cancer cells, and the combination of the two has been seen to have a greater effect in laboratory studies.
Conditions: Non-Small Cell Lung Cancer, Pancreatic Cancer, Melanoma, Lymphoma, Multiple Myeloma
Intervention / Treatment:
DRUG: NPI-0052 (marizomib) + vorinostat
Location: Australia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: OTHER
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Karnofsky Performance Status (KPS) at 70% or more.
2. Non-small cell lung cancer, pancreatic adenocarcinoma, melanoma or lymphoma for which a standard, approved therapy is not available. Patients must have lesions that are evaluable by RECIST criteria.
3. All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to CTCAE (v. 3.0) Grade 1 or less(except for hemoglobin).
4. Adequate bone marrow, renal, liver function.
5. Signed informed consent.
Exclusion Criteria:
1. Recent administration of chemotherapy, biological, immunotherapy or investigational agent, major surgery, or radiotherapy.
2. Intrathecal therapy.
3. Known brain metastases.
4. Significant cardiac disease.
5. Prior treatment with vorinostat or NPI-0052, or other HDACi (including valproic acid) or proteasome inhibitors.
6. Known allergy to any component of vorinostat. Prior hypersensitivity reaction of CTCAE Grade \> 3 to therapy containing propylene glycol or ethanol.
7. Pregnant or breast-feeding women.
8. Concurrent, active secondary malignancy for which the patient is receiving therapy.
9. Significant active infection. | 19,771 |
Study Objectives
The purpose of this study is to determine wether a complementary therapy consisting of a combined medication of selenium, milk thistle, goldenrod and bromelain and a consultation concerning nutrition and physical activity can reduce side effects of a chemotherapy in breast cancer patients.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: two complex naturopathic add-on therapies, leaflet 5-a-day
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Indication for chemotherapy for breast cancer for at least 3 cycles
Exclusion Criteria:
* Prior chemotherapy within 12 months
* use of herbal or nutritional supplements or other complementary or alternative medications ≥ 7 days prior to start of chemotherapy and during the trial
* allergy to study medication
* Selenium intoxication
* Current use of cumarins or other medication influencing the coagulation system
* Edema in case of impaired cardial or renal function
* Other severe medical condition
* Psychiatric or central neurological disorders
* Regular fluid intake \< 2000 ml per day | 8,590 |
Study Objectives
In comparison with transrectal prostate biopsy, transperineal prostate biopsy has the advantage of better sampling from the anterior area, low risk of infection, and no rectal bleeding. The main problems associated with the transperineal method are pain control and additional general or spinal anesthesia. Three types of anesthesia have been reported for transperineal prostate biopsy: (1) spinal anesthesia; (2) general anesthesia; and (3) local anesthesia. From the viewpoint of patient selection (general anesthesia is contraindicated in some patients) and medical cost, local anesthesia is the most suitable choice for prostate biopsy. Periprostatic block is the standard method of local anesthesia for this procedure. However, periprostatic block is insufficient for transperineal prostate biopsy due to high pain sensitivity in this region. A number of new methods to eliminate pain have been reported, including (1) periapical triangle (PAT) block, (2) paraprostatic plus sexual nerve block, and (3) periprostatic block plus pudendal block.However, there is no anatomical basis for some of these methods, and there have been no randomized controlled trials to evaluate their effectiveness, and some methods are technically difficult to learn. In the previous perineal nerve autopsy, we found that there are two branches leading into the prostate and anterior lateral prostatic tissue, which is the main site of puncture pain. There is a fixed position where the two branches appear. Therefore, this anatomical position block may be a useful site for local anesthesia. We named this location the 'transperineal prostate biopsy local anesthesia switch' (abbreviated as TPA switch). In order to validate its effect, we organized this clinical trail.
Conditions: Prostate Biopsy, Local Anesthesia
Intervention / Treatment:
PROCEDURE: local anesthesia of trnasperineal prostate biopsy
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE | Inclusion Criteria:
* 1. ready to be performed transperineal prostate biopsy; 2. fully understand the protocol and aggree to undergo prostate biopsy with local anesthesia which might be elder methods or new experimental method.
Exclusion Criteria:
* 1.do not have the history of anaphylaxis or local anesthetic intoxation； 2. cardiac dysfunction or coagulation dysfunction; 3. Rectal disease which can not allowed to plug the ultrasound probe in; 4.do not fully understand our protocol; 5. do not aggree our protocol. | 31,758 |
Study Objectives
RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have obstructive esophageal tumors.
Conditions: Esophageal Cancer
Intervention / Treatment:
DRUG: HPPH
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: | DISEASE CHARACTERISTICS:
* Histologically confirmed esophageal cancer
* Stages T1-T3, any N, any M
* Tumor partially or completely obstructing the esophagus
* Primary or recurrent tumor meeting 1 of the following criteria for treatment:
* Patient is too debilitated for or refused conventional therapy
* Recurred after or failed to respond to chemotherapy, radiotherapy, or surgery
* Deemed most appropriately treated by photodynamic therapy (PDT) in the opinion of the physician
* Persistent symptomatic disease required in patients who received prior radiotherapy, chemotherapy, or PDT with photofrin or HPPH
* Prior PDT with HPPH allowed only if tumor is evident outside of the original treatment site
* No tracheal or bronchial involvement by bronchoscopy
* No T4 lesions involving the aorta, lung, or pericardium by CT scan, MRI, or endoscopic ultrasonography
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* WBC at least 2,000/mm\^3
* Platelet count at least 50,000/mm\^3
Hepatic
* Bilirubin no greater than 3.0 mg/dL
* Alkaline phosphatase no greater than 3 times upper limit of normal (ULN)
* SGOT no greater than 3 times ULN
* PT no greater than 1.5 times ULN
Renal
* Creatinine no greater than 3.0 mg/dL
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No contraindications to endoscopy
* No porphyria
* No hypersensitivity to porphyrins
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* More than 4 weeks since prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* More than 4 weeks since prior radiotherapy
* No concurrent radiotherapy
Surgery
* Not specified
Other
* No concurrent photosensitizing agents (e.g., tetracyclines, sulfonamides, phenothiazines, sulfonylureas, hypoglycemic agents, thiazide diuretics, and griseofulvin) | 22,535 |
Study Objectives
The purpose of this study is to evaluate the safety and efficacy of NOX A12 alone and in combination with a background therapy of bortezomib and dexamethasone (VD) chemotherapy in previously treated patients with multiple myeloma (MM).
Conditions: Multiple Myeloma
Intervention / Treatment:
DRUG: NOX-A12
Location: Austria, Germany, Italy, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Male or female, aged ≥ 18 years.
2. Diagnosis of relapsed multiple myeloma for which bortezomib/dexamethasone would be given as standard of care.
3. Bortezomib-naïve or bortezomib-sensitive patient (i.e. best response of PR or better, sustained for at least 6 months), who did not receive bortezomib during the last line of therapy for MM prior to this study.
4. Progressive disease according to International Myeloma Working Group criteria.
5. Pre-study WHO Performance Status ≤ 2 and modified CIRS score of less than 7.
6. Signed and dated, written informed consent.
7. Men and women of reproductive potential must agree to follow accepted contraception methods during treatment and for 3 months after completion of treatment.
8. Acceptable liver function: Bilirubin ≤ 1.5 x upper limit of normal (ULN).
9. Acceptable hematology and hemostasis status: Platelet count ≥ 75 x 109/L, ANC \> 0.75x109/L.
10. Acceptable renal function: Serum creatinine ≤1.5 ULN and/or calculated creatinine clearance ≥ 50 mL/min (calculated according to Cockroft \& Gault formula).
11. No clinically significant abnormalities of liver volume, liver hemodynamics or elasticity, measured by abdominal ultrasound.
Exclusion Criteria:
1. The patient has a history of, or is clinically suspicious for, cancer-related Central Nervous System disease.
2. Prior allogeneic stem cell transplant (alloSCT) or patients who are considered to be candidates for alloSCT as assessed by their treating physician.
3. Patient has a history of other active malignancies within 3 years prior to study entry, with the exception of: adequately treated in situ carcinoma of the cervix uteri; basal or squamous cell carcinoma of the skin; in situ carcinoma of the bladder; previous malignancy confined and surgically resected with curative intent.
4. The patient exhibits evidence of other clinically significant uncontrolled condition(s) including, but not limited to: uncontrolled systemic infection (viral, bacterial, or fungal); diagnosis of fever and neutropenia within 1 week prior to study drug administration.
5. Female patient is pregnant or breast-feeding.
6. Known infection with HIV, active Hepatitis B or Hepatitis C.
7. The patient has a history of prior toxicity from bortezomib or dexamethasone that resulted in permanent discontinuation of respective treatments.
8. Clinical evidence of a current significant (grade 2 or higher) or progressive neuropathy.
9. Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to study drug administration.
10. Uncontrolled hypertension (defined as systolic blood pressure \[BP\] \> 160 mm Hg or diastolic BP \> 100 mm Hg).
11. Myocardial infarction or unstable angina within the past 6 months prior to study drug administration. Heart failure of New York Heart Association functional Class III or IV prior to study drug administration.
12. Evidence of bleeding diathesis (greater than normal risk of bleeding) or coagulopathy (in the absence of therapeutic anticoagulation).
13. Systemic illnesses or other severe concurrent disease or alcoholism, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and efficacy of the investigational treatments.
14. Known or suspected of not being able to comply with the trial protocol.
15. Having been previously enrolled in this clinical trial. | 37,653 |
Study Objectives
RATIONALE: PI-88 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I/II trial to study the effectiveness of PI-88 in treating patients who have an advanced malignancy (cancer) or stage IV melanoma.
Conditions: Melanoma (Skin), Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: PI-88
Location: Australia, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
Phase I
* Histologically or cytologically confirmed malignancy
* No other effective treatment available OR failed prior therapy
* No prior or concurrent symptomatic or known CNS involvement or brain or meningeal metastases
Phase II
* Diagnosis of stage IV melanoma
* Metastatic disease must be measurable
* No other effective treatment available OR failed prior therapy
* Asymptomatic brain metastases allowed provided patient is off steroids
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2 OR
* Karnofsky 70-100%
Life expectancy
* At least 3 months
Hematopoietic
* Neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Negative serotonin release assay test for anti-heparin antibodies
* No other abnormal bleeding tendency
* No history of heparin-induced thrombocytopenia
* No history of immune-mediated thrombocytopenia
* No history of thrombolytic thrombocytopenic purpura
* No history of other platelet disease
Hepatic
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* AST and ALT no greater than 2 times ULN (5 times ULN if liver metastases are present)
* PTT normal (20-34 sec)
* PT less than 1.5 times ULN
Renal
* Creatinine clearance greater than 60 mL/min OR
* Glomerular filtration rate greater than 60 mL/min
Cardiovascular
* No myocardial infarction within the past 3 months
* No stroke within the past 3 months
* No congestive heart failure within the past 3 months
Gastrointestinal
* No history of acute or chronic gastrointestinal bleeding within the past 2 years
* No inflammatory bowel disease
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
* No AIDS-related illness
* No serious infection within the past 4 weeks
* No history of alcohol, drug, or other substance abuse
* No history of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents (e.g., heparin)
* No risk of bleeding due to open wounds or planned surgery
* No clinically significant nonmalignant disease
* No uncontrolled infection
Inclusion Criteria
* Current diagnosis of metastatic melanoma, where other effective therapy was not available or had failed.
* Measurable disease. Metastatic lesions had to have been measurable by MRI or CT, and cutaneous lesions by physical examination.
* Biopsiable Lesion Group only: Must have had at least one biopsiable lesion that was bi-dimensionally measurable and previously unirradiated.
* Age≥ 18 years.
* Have voluntarily given written informed consent to participate in this study.
* Performance status: ECOG 0 - 2 (Karnofsky 70 -100%).
* Life expectancy of at least 3 months.
* Neutrophil count \> 1.5 x 109/L (1,500/mm3).
* Platelet count \> 100 x 109/L (100,000/mm3).
* APTT normal (20 - 34 sec).
* PT \<1.5 x ULN.
* Calculated creatinine clearance, using the Cockcroft-Gault formula, \>60 mL/min. If just below 60 mL/min, then GFR\>60 mL/min as determined by EDTA or DTPA scan.
* Bilirubin \<1.5 x ULN.
* AST and ALT up to 2 x ULN; except in the presence of liver metastases; up to 5 x ULN.
Exclusion Criteria
* Current symptomatic central nervous system involvement, or active brain or meningeal metastases.
* Concomitant use of aspirin (\> 100 mg/day), non-steroidal anti-inflammatory drugs (with the exception of COX-2 inhibitors), heparin, low molecular weight heparin or warfarin (\> 1 mg/day) which was ongoing or anticipated during the study period. Low-dose aspirin (100 mg/day or less) or low-dose warfarin (1 mg/day or less) was permitted.
* Heparin or low molecular weight heparin within the previous 2 weeks.
* Chemotherapy, investigational therapy or hormonal therapy in the previous 4 weeks.
* Radiotherapy to a major bone marrow bearing area such as pelvis, femoral heads, lumbar-sacral spine, within the previous 4 weeks. Radiotherapy to other sites within the previous 2 weeks.
* History of allergy and/or hypersensitivity to anti-coagulants/thrombolytic agents, especially heparin.
* History of heparin-induced thrombocytopenia, immune mediated thrombocytopenia, thrombotic thrombocytopenic purpura and/or other platelet diseases, or laboratory evidence of anti-heparin antibodies.
* Myocardial infarction, stroke or congestive heart failure within the previous 3 months
* History of acute or chronic gastrointestinal bleeding within the previous two years, inflammatory bowel disease, any other abnormal bleeding tendency, or patients at risk of bleeding due to open wounds or planned surgery.
* Uncontrolled infection or serious infection within the previous 4 weeks.
* Clinically significant non-malignant disease.
* Known AIDS-related illness or HIV positive.
* Women who were pregnant, breast feeding, or of childbearing potential in whom pregnancy could not be excluded.
* History of abuse of alcohol, drugs or other substances.
* Not recovered from major surgery if conducted prior to the study.
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* More than 4 weeks since prior chemotherapy
Endocrine therapy
* More than 4 weeks since prior hormonal therapy
Radiotherapy
* More than 2 weeks since prior radiotherapy
* More than 4 weeks since prior radiotherapy to a major bone-marrow bearing area (e.g., pelvis, femoral heads, or lumbar-sacral spine)
* Concurrent palliative radiotherapy allowed
Surgery
* Recovered from prior major surgery
* No concurrent surgery
Other
* More than 2 weeks since prior heparin or low-molecular weight heparin
* More than 4 weeks since other prior investigational therapy
* No other concurrent investigational drugs
* No other concurrent antineoplastic therapy
* No concurrent aspirin or aspirin-containing medications
* No concurrent nonsteroidal anti-inflammatory drugs
* Concurrent cyclooxygenase-2 inhibitors allowed
* No concurrent heparin or low-molecular weight heparin
* No concurrent warfarin or warfarin-containing medications
* No other concurrent anticoagulant medications | 5,179 |
Study Objectives
This phase I trial studies the side effects of 68GA-PSMA-11 PET imaging in patients with prostate cancer that has come back (recurrent). Gallium (68Ga) is a radiotracer that binds to a molecule, PSMA, that is found in abundance on most prostate cancer cells. PSMA is short for 'prostate specific membrane antigen'. Diagnostic procedures, such as 68GA-PSMA-11 PET imaging, may help measure a patient's response to earlier treatment, and may help plan the best treatment for prostate cancer.
Conditions: Biochemically Recurrent Prostate Carcinoma
Intervention / Treatment:
DRUG: Gallium Ga 68-labeled PSMA-11, PROCEDURE: Positron Emission Tomography
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Biochemical recurrent prostate cancer
* Karnofsky performance status of \>= 50
* The effects of 68Ga-PSMA-11 on the developing fetus are unknown. For this reason, subjects must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation when having sex with a pregnant female or with a female partner of childbearing potential
* Co-enrollment on IRB 18517
* Documented informed consent of the patient. All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
* Patients should not have any uncontrolled illness including ongoing or active infection
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to 68Ga-PSMA-11
* Use of another concomitant investigational therapy (with the exception of the investigational treatment given in IRB 18517) for prostate cancer within 7 days of scheduled 68Ga-PSMA-11 PET scan
* Unable to tolerate PET scan (i.e. if the patient is claustrophobic or unable to lie still for 30-60 minutes)
* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study | 344 |
Study Objectives
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict a patient's response to treatment.
PURPOSE: This laboratory study is looking at DNA in tissue samples from women with breast cancer to see if it can predict treatment outcome.
Conditions: Breast Cancer
Intervention / Treatment:
GENETIC: mutation analysis, GENETIC: polymorphism analysis, OTHER: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer
* Node-negative breast cancer
* Enrolled on clinical trial SWOG-8897
* Archived tissue from patients with normal lymph nodes in the low-risk group receiving no treatment and those in the intermediate group receiving treatment
* Hormone receptor status known
PATIENT CHARACTERISTICS:
* Female
* Pre- or post-menopausal
PRIOR CONCURRENT THERAPY:
* Not specified | 6,702 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of aminopterin in treating patients who have refractory leukemia.
Conditions: Leukemia
Intervention / Treatment:
DRUG: aminopterin, DRUG: leucovorin calcium
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS: Histologically proven acute leukemia of any histologic type that is refractory to known effective therapy
PATIENT CHARACTERISTICS: Age: Any age Performance status: Karnofsky 50-100% Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL ALT no greater than 5 times upper limit of normal Renal: Creatinine normal for age Cardiovascular: No unstable angina No uncontrolled arrhythmia Pulmonary: No third space effusion Other: No severe uncontrolled infection Adequate nutritional status At least third percentile for weight Normal total serum protein Normal albumin/globulin ratio No serious concurrent physical or mental illness Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 months since prior bone marrow transplantation Recovered from prior biologic therapy No concurrent anticancer biologic therapy Chemotherapy: Recovered from prior chemotherapy No concurrent anticancer chemotherapy Endocrine therapy: Recovered from prior endocrine therapy No concurrent anticancer endocrine therapy No concurrent dexamethasone or other steroids as antiemetic agents Radiotherapy: No concurrent anticancer radiotherapy Surgery: Not specified Other: No concurrent dairy products for 2-4 hours before, during, or 2-4 hours after study drug No concurrent trimethoprim-sulfamethoxazole or dapsone as prophylaxis for Pneumocystis infection No concurrent multivitamins containing folic acid | 44,640 |
Study Objectives
GAND-emesis is a multinational, randomized, double-blind, placebo-controlled, parallel-group study to investigate the efficacy and tolerability of a neurokinin1 receptor antagonist (fosaprepitant dimeglumine) in combination with an antiemetic (anti-nausea-and-vomiting) control regimen (palonosetron and dexamethasone) in patients with a gynaecological cancer diagnosis, who are scheduled to receive radiotherapy and weekly chemotherapy.
The study aims at investigating if a three-drug antiemetic regimen is superior to a two-drug regimen (standard treatment) in preventing nausea and vomiting in patients receiving radiotherapy and weekly chemotherapy. A pilot study demonstrated that approximately 50% of patients will experience nausea and vomiting when offered a two-drug antiemetic regimen, and it is expected that addition of a third drug (a neurokinin1 receptor antagonist) can increase the proportion of patients with no vomiting in the course of combined chemo-radiotherapy.
Conditions: Nausea, Vomiting, Genital Neoplasms, Female
Intervention / Treatment:
DRUG: Fosaprepitant dimeglumine, DRUG: Placebo
Location: Germany, Australia, Norway, Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria: (abbreviated)
1. The patient has a diagnosis cervical cancer.
2. The patient understands the nature and purpose of this study and the study procedures and has signed informed consent.
3. The patient is aged \> 18 years.
4. The patient must be both chemo- and radiotherapy (RT) naïve. NB: previously low voltage RT or electron RT for non-melanoma skin cancers is allowed.
5. The patient is scheduled to receive fractionated radiotherapy and concomitant weekly cisplatin at a dose of ≥ 40 mg/m2 for at least five weeks.
6. Brachy therapy is scheduled to be initiated after the third cycle of weekly cisplatin, and preferentially after the fifth week of treatment.
7. Chemotherapy with an emetic risk potential of minimal or mild (up to 30%) is allowed on days 1-4 (see ref. 14).
8. The patient has a WHO Performance Status of ≤ 2.
Exclusion Criteria: (abbreviated)
1. The patient has a current malignant diagnosis other than cervical cancer, with exception of non-melanoma skin cancers.
2. The patient is aged \< 18 years.
3. The patient is scheduled to receive less than five weeks of fractionated radiotherapy and concomitant weekly cisplatin.
4. Brachy therapy is planned to be initiated before the third cycle of weekly cisplatin.
5. The patient has been previously treated with radiotherapy, and/or chemotherapy, with exception of treatment with low voltage RT or electron RT for non-melanoma skin cancers .
6. The patient has a WHO Performance Status of \> 2. | 41,452 |
Study Objectives
The investigators prospectively evaluated in this study the efficacy and safety profiles of afatinib as 3rd or 4th line treatment after prior failure to systemic chemotherapy and first-generation EGFR-TKI under a Boehringer Ingelheim sponsored Compassionate Use Program (CUP), with comparison of our historical cohort who received erlotinib after previous failure to systemic chemotherapy and first-generation EGFR-TKI.
Conditions: Lung Cancer
Intervention / Treatment:
DRUG: Afatinib, DRUG: Erlotinib
Location: Hong Kong
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Patients with stage IV epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer who were previously responsive to one line of EGFR tyrosine kinase inhibitor and at least one line of systemic chemotherapy
* Adequate hematological function (ANC \>=1.5 x 10\^9/l, Hb \>=9.0 x 10\^9/l, plt \>=100 x 10\^9/l)
* Adequate renal function (with estimated creatinine clearance \>=50ml/min as determined by Cockcroft-Gault formula)
* Adequate liver function (ALT/AST \<2.5 x upper normal limit or ALT/AST \<5 x upper normal limit in the presence of liver metastasis)
* Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
* Evaluable target lesions according to RECIST 1.1 for tumour response assessment
* Patients able to give written consent
Exclusion Criteria:
* Symptomatic brain metastases requiring steroids/surgery/radiation therapy within 4 weeks of commencement of study medication
* Significant cardiovascular abnormalities
* Significant psychiatric disorders
* Patients who have documented history of interstitial lung disease | 22,688 |
Study Objectives
The purpose of the study is to find out the highest dose of vandetanib that can be safely given with repeat radiation therapy.
This study drug has been designed to block certain chemical pathways that stimulate tumor to grow. The study drug has been shown to slow the growth of a number of types of cancers.
This will be a dose escalation study. A dose escalation study means that successive groups of patients will receive higher doses of the study drug. There are three dose levels. The dose of the study drug received will depend on the stage the study has reached at the time a patient decides to participate.
In addition to taking the study drug patients will also receive radiation therapy to the brain tumor for 3 days.
Hypothesis The objective of this study is to determine the maximally tolerated dose (MTD) of VANDETANIB given with 36 Gy hypofractionated stereotactic radiotherapy. The MTD will be dose of VANDETANIB at which no patients develop acute grade 5 toxicity and less than 30% of patients develop acute (within 30 days of radiation therapy) or delayed (at least 30 days after radiation completed) dose limiting toxicities.
Conditions: Malignant Gliomas
Intervention / Treatment:
DRUG: Vandetanib, RADIATION: Fractionated Stereotactic Radiotherapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients with histopathologically confirmed malignant gliomas that recurred after surgical resection and conventional radiation therapy
* Tumor is not located in the eloquent part of the brain and not touching the brainstem, optic chiasm or optic nerve so that these critical structures will not receive full dose of re-irradiation
* Recurrent tumor is not surgically resectable or patient is not medically operable
* Age \> 18 years.
* Radiographical evidence of local recurrence on brain MRI, with or without histopathological confirmation.
* Estimated survival of at least 3 months
* Zubrod Performance Scale of 0-2
* Hgb greater than 10 gm/dl, absolute neutrophil count greater than 1500/ul, platelets greater than 100,000/ul, blood urea nitrogen (BUN) less than 25 mg/dl, Bilirubin less than 2.0 mg/dl, serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than 2 x normal range
* Less than or equal to 3 recurrent tumors, and combined largest diameter of all tumors less than or equal to 6 cm
* Single recurrent tumor less than or equal to 6 cm in the largest diameter
Exclusion Criteria:
* Prior therapy with any anti-Epidermal growth factor receptor(EGFR) and/or anti-VEGFR therapies
* Recurrent tumor greater than 6 cm in the largest diameter
* Recurrent tumor located in the brainstem.
* Prior radiation therapy to the brain within 2 months.
* Evidence of severe or uncontrolled systemic disease or any concurrent condition (such as severe cognitive impairment)
* pregnant and breast-feeding women will be excluded
* Treated on any other clinical protocols or with a non-approved or investigational drug within 30 days before Day 1 of study treatment.
* Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
* Clinically significant cardiac event
* History of arrhythmia. Atrial fibrillation, controlled on medication is not excluded.
* Previous history of corrected electrocardiogram QT interval (QTc)prolongation as a result from other medication that required discontinuation of that medication.
* Congenital long QT syndrome, or 1st degree relative with unexplained sudden death under 40 years of age
* Presence of left bundle branch block QTc with Bazett's correction that is unmeasurable, or 480 msec on screening ECG. If a patient has QTc 480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be less than 480 msec in order for the patient to be eligible for the study.
* Concomitant medication that may cause QTc prolongation, induce Torsades de Pointes or induce cytochrome P450 3A4 (CYP3A4) function Hypertension not controlled by medical therapy (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg)
* Active diarrhea that may affect the ability of the patient to absorb the VANDETANIB.
* Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy
* Clinical and/or radiographic evidence of bleeding in the recurrent brain tumor.
* Patients currently on enzyme inducing anticonvulsants. However, patients are eligible if the enzyme inducing anticonvulsants can be discontinued or switched to non- enzyme inducing anticonvulsants one week before study entry. Non-enzyme inducing anticonvulsants cannot be those which may cause QTc prolongation, induce Torsades de Pointes or induce CYP3A4 function
* Laboratory results:
* Serum bilirubin greater than 1.5 x the upper limit of reference range (ULRR)
* Serum creatinine greater than 1.5 x ULRR or creatinine clearance less than 50 mL/minute (calculated by Cockcroft-Gault formula)
* Potassium, less than 4.0 mmol/L despite supplementation; serum calcium (ionized or adjusted for albumin,) or magnesium out of normal range despite supplementation
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 X ULRR | 28,586 |
Study Objectives
This clinical trial studies how well yttrium-90 (Y90) glass microspheres positron emission tomography (PET)/computed tomography (CT) works in imaging patients with liver tumors . Images produced by PET/CT may provide better information about the distribution of particles, such as Y90 glass microspheres, delivered for selective internal radiation therapy (SIRT) as compared to regular medical care images useing technetium Tc-99m albumin-aggregated single photon emission computed tomography (SPECT)/CT images.
Conditions: Primary Malignant Liver Neoplasm
Intervention / Treatment:
PROCEDURE: Computed Tomography (CT), PROCEDURE: Positron Emission Tomography (PET), DEVICE: 90-Yttrium (Y-90) Glass Microspheres, DIAGNOSTIC_TEST: Technetium 99mTc albumin aggregated (99mTc-MAA), PROCEDURE: Single-photon emission computerized tomography (SPECT) scan
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patient provides written informed consent
* Patient is referred for 90Y SIRT radioembolization of liver tumor(s)
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (approximately 30 minutes total for digital PET/CT)
Exclusion Criteria:
* Patient is pregnant or nursing | 21,549 |
Study Objectives
RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Exemestane may be effective in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density.
PURPOSE: Randomized clinical trial to study the effectiveness of exemestane in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density in postmenopausal women who are at increased risk for breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: exemestane, DRUG: Placebo
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE | DISEASE CHARACTERISTICS:
* Radiologically confirmed density occupying at least 25% of the breast tissue on baseline mammogram\*
* Grade 2, 3, 4, 5, or 6 (Boyd classification)
* Participants with different grades between the 2 breasts should be classified according to a higher grade NOTE: \*Performed within 6 months before study entry
* Bone mineral density T-score of either posterior-anterior spine or hip (femoral neck) must be no greater than 2.0 standard deviations below the mean value of peak bone mass in young normal women as determined by DEXA scan within the past 6 months
* No concurrent breast cancer
* No prior invasive breast cancer or ductal carcinoma in situ
* No breast implants
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* Postmenopausal
Sex
* Female
Menopausal status
* Postmenopausal, defined as 1 of the following:
* Over 50 years of age with no spontaneous menses for at least 1 year
* 50 years of age and under with no menses (e.g., spontaneous or secondary to hysterectomy) within the past year AND a follicle-stimulating hormone level within institution postmenopausal range
* Bilateral oophorectomy
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* No cardiovascular disease
* No history of myocardial infarction
* No history of stroke
* No uncontrolled high blood pressure
Other
* No uncontrolled metabolic or endocrine disease
* No malabsorption syndrome
* No known hypersensitivity to exemestane or its excipients
* No other malignancy within the past 5 years except curatively treated squamous cell or basal cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior immunotherapy
* No concurrent immunotherapy
Chemotherapy
* No prior chemotherapy
* No concurrent chemotherapy
Endocrine therapy
* More than 3 months since prior exogenous estrogen and/or progesterone/progestin therapy
* More than 6 months since prior selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene)
* No concurrent selective estrogen-receptor modulators (e.g., tamoxifen, toremifene, or raloxifene)
* No concurrent steroids
* Vaginal estrogens allowed (e.g., Estring® or Vagifem®)
* No concurrent compounded creams
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* More than 4 weeks since prior investigational agents
* No other concurrent medications that would preclude study endpoints
* No concurrent over-the-counter products or supplements considered to have an estrogenic effect, including any of the following:
* Ginseng
* Ginkgo biloba
* Black cohosh
* Dong quai
* Fortified soy supplements (e.g., phytoestrogen preparations) | 26,969 |
Study Objectives
ITALUNG is a RCT for the evaluation of the efficacy of lung cancer screening with low-dose Computer Tomography (LDCT) , carried out in three screening centers in Florence, Pisa and Pistoia districts of the Tuscany region of Italy.
3106 high risk subjects (age 55-69, smokers or ex-smokers) were recruited and randomized to the Active arm (Baseline + 3 annually repeated LDCT screening) or to the Passive arm, followed up in usual care (no screening reccomended ) All subjects were invited, if smokers, to consider smoking cessation practice. Follow-up for cause specific mortality and overall mortality and for lung cancer incidence was performed (actually at 9.3 years since randomization) . Blood and sputum samples were stored from the Active arm in a Biobank, with 1304 subjects enrolled in the Italung Biomarker study.
Conditions: Lung Cancer
Intervention / Treatment:
DEVICE: Low Dose Computed Tomography
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Resident in the catchment area, in the list of GP's
* Current smoker
* Ex-smoker (\<8years)
Exclusion Criteria:
* Non smoker
* Ex-smoker (=\>8years) | 35,122 |
Study Objectives
The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patients (n=800) will be randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to measure shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will conduct medical chart review to track receipt of colon cancer screening within 6 months. The statistician will test whether patients in the intervention arm report more shared decision making, less decisional conflict, higher intention to follow through on screening and have higher screening rates compared to those in the control arm.
Conditions: Colon Cancer
Intervention / Treatment:
BEHAVIORAL: Shared Decision Making
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Adults, age 45-75
* Had screening or surveillance colonoscopy delayed or cancelled from March-June 2020
Exclusion Criteria:
* Diagnostic colonoscopy
* High risk for colorectal cancer as indicated by 1 year follow up schedule
* Prior history of colon cancer
* Unable to read or write in English or Spanish
* Have already scheduled or completed a colonoscopy since restrictions were lifted | 19,858 |
Study Objectives
This is an open-label, 2 part study of pazopanib and/or MK 3475 in treatment naïve subjects with advanced RCC. Part 1 consists of a Phase I dose escalation of pazopanib + MK 3475 followed by an expansion cohort to determine the maximum tolerated regimen and the recommended Phase II dose. Part 2 is a randomized 3-arm Phase II study to evaluate the clinical efficacy and safety of pazopanib + MK 3475 as compared to single-agent pazopanib and single-agent MK 3475. The objectives of this Phase I/II study are to test the safety and tolerability of pazopanib in combination with MK 3475, and study the clinical efficacy of pazopanib in combination with MK 3475 in subjects with advanced RCC as compared with single-agent pazopanib and single-agent MK 3475.
Following the Urgent Safety Measure (USM) released on February 09, 2017, the phase II (Part 2) portion of this study will not commence.
Conditions: Carcinoma, Renal Cell
Intervention / Treatment:
DRUG: Pazopanib, DRUG: MK-3475
Location: United States, United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Signed written informed consent before performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up
* Diagnosis of locally advanced or metastatic RCC that is predominantly clear cell histology
* Must have measurable disease
* Subject has received no prior systemic therapy
* A woman is eligible to participate in the study if she is of Non-childbearing potential, has a negative serum pregnancy test within 7 days of the first dose of study treatment, not lactating, and agrees to use adequate contraception during the study until at least 120 days after the last dose of investigational product
* Eastern Cooperative Oncology Group performance status 0 or 1
* Adequate organ function as defined in the protocol
* Left ventricular ejection fraction \>= lower limit of normal as assessed by echocardiogram or multigated acquisition scan
* In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Exclusion Criteria:
* Subject has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
* Subject is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of the first dose of study treatment
* Subject is expected to require any other form of systemic or localized antineoplastic therapy while on study
* Subject is on any systemic steroid therapy, within one week before the planned date for first dose of study treatment. Subject is on any other form of immunosuppressive medication
* Subject has a history of a malignancy (other than the disease under treatment in the study) within 5 years before first study treatment administration
* Central nervous system metastasis
* Unable to swallow and retain orally administered medication
* Subject has interstitial lung disease or a history of pneumonitis
* Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis, or other Gastrointestinal conditions with increased risk of perforation; history of abdominal fistula, GI perforation, or intra-abdominal abscess within 4 weeks before beginning study treatment
* Known history of HIV infection or a known history of or is positive for Hepatitis B or Hepatitis C
* Presence of active infection requiring systemic therapy
* Corrected QT interval duration prolongation
* History of any one or more of the following cardiac conditions within the past 6 months: Cardiac angioplasty or stenting; Myocardial infarction; Unstable angina; History of Class III or IV congestive heart failure according to New York Heart Association classification
* History of cerebrovascular accident within the past 6 months
* Poorly controlled hypertension
* History of untreated deep venous thrombosis
* Presence of any non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Recent hemoptysis
* Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage
* Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures
* Previous severe hypersensitivity reaction to another Monoclonal antibody. Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the excipients in pazopanib tablets
* Has taken any prohibited medications that are listed in the protocol within 14 days of the first dose of study treatment. Subject has received or will receive a live vaccine within 30 days before the first administration of study treatment | 29,857 |
Study Objectives
To examine the safety and efficacy of telomerase peptide vaccination ( stimulation of the immune system) in patients with NSCLC after having been treated with conventional therapy with radiotherapy and docetaxel as a radiosensitizer.
Conditions: Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
BIOLOGICAL: GV 1001 Telomerase peptide
Location: Norway
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients with inoperable NSCLC, disease stage IIIA and stage IIIB, who has received concurrent chemoradiotherapy( typically docetaxel 20 mg/m2 and 3D radiotherapy, 2Gy x 30 within the last 4 weeks.
* No sign of brain metastasis( excluded by MRI of the brain)
* Male or female above the age of 18 years.
* Normal lab. values | 27,092 |
Study Objectives
XRD-0394 is a novel, potent, oral, small molecule dual inhibitor of ataxia telangiectasia mutated kinase (ATM) and deoxyribonucleic acid (DNA)-dependent protein kinase (DNA-PK) that has selectivity compared with other phosphatidylinositol 3-kinase-related kinase (PIKK) family enzymes. This is a first-time-in-human study, which means that it is the first time the study drug is being used in humans. The purpose of the study is to evaluate the safety and tolerability of single doses of XRD-0394 administered with palliative radiotherapy (RT) to subjects with metastatic, locally advanced, or recurrent cancer. The pharmacokinetic (PK) profile and pharmacodynamic (PD) effects of single-dose XRD-0394 administered in combination with palliative RT will also be characterized.
Conditions: Metastasis, Locally Advanced Solid Tumor, Recurrent Cancer
Intervention / Treatment:
DRUG: XRD-0394, RADIATION: Palliative radiotherapy
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Inclusion Criteria:
* Histologically confirmed diagnosis of cancer with clear evidence of metastasis on imaging. Subjects with locally advanced or recurrent (non-metastatic) cancer for whom palliative RT is indicated may also be enrolled.
* Scheduled to receive palliative RT delivered as 4 Gray × 5 daily fractions at the discretion of the treating radiation oncologist. The radiation plan should be designed to optimally limit the radiation dose delivered to normal tissues using conformal treatment plans and protocol-specified limits.
* One or more of the following sites of metastasis:
* Skin
* Subcutaneous or soft tissue
* Any other site that will allow the radiation dose to normal structures to remain within protocol-specified dosing limits.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
* Male or female subjects at least 18 years of age who are willing and able to provide written informed consent.
* Other protocol-defined criteria may apply
Exclusion Criteria:
* Prior radiotherapy to the same region within the last 6 months.
* Subjects who are currently receiving palliative RT for brain metastases. Subjects who have brain metastases may participate in this trial, if they are receiving palliative RT for cancer in a location other than the brain.
* For subjects with cancers involving the spinal cord, the length of the spinal cord requiring palliative treatment must be 10 cm or less.
* Subjects with bone marrow impairment as evidenced by hemoglobin \<8.0 g/dL, neutrophil count \<0.7 × 10\^9/L, or platelets \<80 × 10\^9/L .
* History of difficulty swallowing, malabsorption or other chronic gastrointestinal disease or condition that may hamper compliance and/or absorption of XRD-0394, use of percutaneous endoscopic gastrostomy (PEG) tubes.
* Significant cardiac conduction abnormalities, including a history of long corrected QT (QTc) interval syndrome and/or pacemaker, or impaired cardiovascular function such as New York Heart Association classification \>2.
* Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other anticancer therapy within 14 days of first XRD-0394 dose. These treatments should also be held for a minimum of 14 days after completion of RT.
* Subjects receiving bleomycin within 30 days of the first dose of XRD-0394.
* Subjects receiving treatment with any drug that is a strong inhibitor or inducer of cytochrome P450 (CYP) 3A4 enzyme activity or an inhibitor of breast cancer resistance protein (BCRP) within 14 days or 5 half-lives prior to screening (whichever is longer). In particular,
* Glucocorticoids are inducers of CYP3A4. Therefore, dexamethasone, prednisone, or other glucocorticoids should not be administered within 14 days or 5 half-lives prior to screening (whichever is longer) and should only be initiated after the course of palliative RT is complete (and at least 24 hours after the administration of XRD-0394).
* Gefitinib and imatinib are inhibitors of BCRP. Therefore, these agents should not be administered within 14 days or 5 half-lives prior to screening (whichever is longer) and should be held for a minimum of 14 days after completion of RT.
* Participation in another investigational study of an unapproved drug or device or treatment with another ATM, DNA-PK, or ataxia-telangiectasia and Rad3-related (ATR) inhibitor within 28 days of the first dose of XRD-0394.
* Subjects who are pregnant or breast-feeding.
* Subjects with a QTc interval \>450 msec (calculated using Fridericia's QT correction formula) at screening. | 24,470 |
Study Objectives
This trial studies how the Three-Factor Eating Questionnaire works in measuring eating behavior in adolescent and young adult survivors of central nervous system (CNS) tumors. The Three-Factor Eating Questionnaire is comprised of three factors, including cognitive restraint, uncontrolled eating, and emotion eating. The Eating Questionnaire - Ecological Momentary Assessment method measures a patient's recent experiences and behavior, such as eating behavior, as they continue their daily living. Giving the Three-Factor Eating Questionnaire and the Eating Questionnaire - Ecological Momentary Assessment may help researchers measure eating behaviors more effectively in adolescent and young adult survivors of CNS tumors.
Conditions: Cancer Survivor
Intervention / Treatment:
OTHER: Nutritional Assessment, OTHER: Questionnaire Administration, OTHER: Questionnaire Administration
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Adolescent or young adult (AYA) who has survived a primary CNS tumor
* Has been off therapy without relapse for at least 6 months
* Able to speak, write, and read in English
* Has access to the internet
* Has telephone access
* Currently lives in the United States
Exclusion Criteria:
* Is in foster care
* Is experiencing severe cognitive impairments that do not allow them to engage in basic conversations (excluding individuals who may experience severe cognitive impairments because participants will need to provide assent \[if \< 18 years old\] or consent \[if \>= 18 years old\] and will need to have the ability to independently complete the TFEQ-R18v2, Multifactor screener, and EQ-EMA. Through the phone screening conducted by the M D Anderson Cancer Center \[MDACC\] graduate research assistant \[GRA\], a person is determined to not be severely cognitive impaired if the participant is able to respond to basic questions such as their age, whether or not they have internet access, and telephone.)
* Is incarcerated at the time of enrollment | 33,918 |
Study Objectives
Phase I trial to study the effectiveness of irofulven in treating children with recurrent or refractory solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells so they stop growing or die.
Conditions: Unspecified Childhood Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: irofulven
Location: Canada, Australia, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically or cytologically proven recurrent or refractory solid tumors
* No leukemia
* Patients with brain tumors are not eligible until the first 2 patients at each dose level are evaluable for toxicity
PATIENT CHARACTERISTICS:
* Age: 21 and under
* Performance status: Karnofsky 50-100% Lansky play scale 50-100% (for infants)
* Life expectancy: At least 8 weeks
* Absolute neutrophil count at least 1,000/mm3
* Hemoglobin at least 9 g/dL
* Platelet count at least 75,000/mm3
* Bilirubin less than 1.5 mg/dL
* SGPT less than 5 times upper limit of normal
* Creatinine normal for age OR GFR at least 70 mL/min
* Cardiac shortening fraction at least 27% OR institutional normal OR cardiac ejection fraction greater than 50% OR institutional normal
* Neurologic deficits in patients with CNS tumors must be stable for at least 2 weeks
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after the study
* No uncontrolled infection
PRIOR CONCURRENT THERAPY:
* At least 1 week since prior growth factor therapy and recovered
* At least 6 months since prior bone marrow transplantation and no evidence of graft versus host disease
* At least 2 weeks since prior myelosuppressive chemotherapy and recovered
* At least 6 weeks since prior nitrosourea and recovered
* At least 2 weeks on stable dexamethasone for patients with CNS tumors
* No concurrent chemotherapy
* At least 2 weeks since prior palliative radiotherapy (small port)
* At least 6 months since prior substantial bone marrow radiation
* At least 6 months since total abdominal, pelvic, chest, mantle, and Y ports radiotherapy
* No other concurrent anticancer therapy or investigational agents | 34,973 |
Study Objectives
Rapamune (generic name: Sirolimus®) is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has not been approved at this time for the treatment of cancer. Herceptin is a new form of chemotherapy that has been approved by the Food and Drug Administration for the treatment of breast cancer.
This study is designed to evaluate the effect and safety of combining Rapamune and Herceptin on breast cancer. Rapamune and Herceptin are being combined because results from our laboratory studies suggest that the combination of the two drugs is superior to either drug used alone. Results from laboratory studies performed at other institutions suggest that adding Rapamune to Herceptin may also reverse the resistance to Herceptin. Although there has been extensive experience using Herceptin alone and Rapamune alone in human subjects, the combination of Herceptin and Rapamune has not been previously evaluated. In addition, we hope to better understand how these treatments work against an individual woman's tumor by analyzing tissue samples before, and during treatment.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Rapamycin, DRUG: Trastuzumab
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically confirmed HER2 overexpressing (IHC 3+ and/or FISH +) metastatic breast cancer with measurable disease. Patients with either HER2 3+ positive tumors by immunohistochemistry (Dako Herceptest®) or gene amplification (\> 2 copies) by fluorescence in-situ hybridation (FISH) are eligible.
* Progression following at least 8 weeks of standard doses of Herceptin or a Herceptin containing regimen.
* Off Herceptin for a minimum of 2 weeks.
* Patients must have measurable disease as defined by RECIST guidelines (the lesion that will be biopsied on study cannot be the only measurable lesion).
* Life expectancy \> 3 months
* Age ≥18 years
* ECOG performance status ≤2
* Adequate bone marrow function as indicated by the following:
* ANC ≥1500/µL
* Platelets ≥100,000/µL
* Hemoglobin ≥9 g/dL
* Adequate liver function, as indicated by bilirubin ≤1.5 x ULN, AST or ALT \<2x ULN.
* Adequate renal function, as indicated by creatinine \<1.5 x upper limit of normal (ULN)
* Ability to understand and the willingness to sign a written informed consent.
* Adequate birth control: Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and must have a negative serum or urine pregnancy test within 1 week prior to beginning treatment on this trial. Pregnant and nursing patients are excluded because the effects of the combination of Rapamycin on a fetus or nursing child are unknown. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Fasting serum cholesterol \<350 mg/d L and triglycerides \< 400 mg/ d L.
* Biopsy is required but patients or physicians may opt out of this part of the trial if sufficient justification is provided. Justification must be provided to the PI in writing indicating excessive physical risk or psychological trauma if biopsy is undertaken.
Exclusion Criteria:
* Active infection or treatment for systemic infections within 14 days of enrollment
* Patients with active brain metastases requiring treatment, inclusive but not limited to surgery, radiation, and corticosteroids (patients with asymptomatic non- progressing brain metastasis who have completed treatment ≥30 days before enrollment and without evidence of progression on a post treatment MRI may be considered for the study).
* Pregnant or lactating women
* Prior chemotherapy within the last 4 weeks (last 6 weeks for nitrosureas/mitomycin)
* Prior radiation therapy within the last 4 weeks; prior radiation therapy to indicator lesion (unless objective disease recurrence or progression within the radiation portal has been documented since completion of radiation).
* Prior therapy with rapamycin, rapamycin analogs, or experimental agents targeting mTOR.
* Concomitant malignancies or previous malignancies within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
* Ejection fraction \<50% or below the lower limit of the institutional normal range, whichever is lower
* Hypersensitivity to trial medications
* Patients may not be receiving any other investigational agents within 30 days before enrollment.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women are excluded from this study because the investigational agents may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued if the mother is treated.
* HIV-positive patients are ineligible because these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy and the potential pharmacokinetic interaction between antiretroviral therapy and the investigational agents.
* Use of all herbal and alternative medications within 4 weeks. All herbal and alternative medications should be discontinued while on study, these include but not limited to: Hydrastis canadensis (goldenseal) - Uncaria tomentosa (cat's claw) - Echinacea angustifolia roots - trifolium pratense (wild cherry) - matricaria chamomila (chamomile) - Glycyrrhiza glabra (licorice) - dillapiol - naringenim.
* Use of any of these medications within 4 weeks; cyclosporine, diltiazen, ketoconazole, rifampin, fluconazole, delavirdine, nicardipine, pioglitazone, and sulfonamides, erythromycin, clarithromycin, itraconazole, erythromycin, metoclopramide, nevirapine, phenobarbital, phenytoin, indinavir, fosamprenavir, nefazadone, St Johns Wort.
* Consumption of grapefruit juice is prohibited during the study.
* Use of warfarin (Coumadin), immunosuppressive agents or chronic oral, intravenous or topical steroid | 41,190 |
Study Objectives
This phase II trial studies how well sorafenib tosylate and yttrium Y 90 glass microspheres work in treating patients with liver cancer that cannot be removed by surgery. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Yttrium Y 90 glass microspheres use glass beads to carry radiation directly to tumor cells without harming normal cells. Giving sorafenib tosylate with yttrium Y 90 glass microspheres may be an effective treatment for liver cancer.
Conditions: Advanced Adult Hepatocellular Carcinoma, BCLC Stage C Hepatocellular Carcinoma, Recurrent Adult Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7, Stage IIIA Hepatocellular Carcinoma AJCC v7, Stage IIIB Hepatocellular Carcinoma AJCC v7, Stage IIIC Hepatocellular Carcinoma AJCC v7, Stage IV Hepatocellular Carcinoma AJCC v7, Stage IVA Hepatocellular Carcinoma AJCC v7, Stage IVB Hepatocellular Carcinoma AJCC v7, Unresectable Hepatocellular Carcinoma
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, OTHER: Quality-of-Life Assessment, DRUG: Sorafenib, DRUG: Sorafenib Tosylate, RADIATION: Yttrium Y 90 Glass Microspheres
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Subjects must be able to understand and be willing to sign the written informed consent form; a signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure
* Life expectancy of at least 12 weeks (3 months)
* Patients with histological or cytologically documented hepatocellular carcinoma (HCC) (documentation of original biopsy for diagnosis is acceptable if tumor tissue is unavailable) or clinical diagnosis by American Association for the Study of Liver Diseases (AASLD) criteria in cirrhotic subjects is required; for subjects without cirrhosis histological confirmation is mandatory
* Patients must have at least one tumor lesion that meets the following criteria: the lesion can be accurately measured in at least one dimension according to Response Evaluation Criteria in Solid Tumor (RECIST)
* The target lesion(s) has not been previously treated with local therapy (such as surgery, radiation therapy, hepatic arterial therapy, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation)
* Patients who have received local therapy, such as surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection or cryoablation are eligible if the previously treated lesions have progressed or recurred can be identified as target lesions; local therapy must have been completed at least 4 weeks prior to the baseline scan
* Patients who have received yttrium-90 microspheres are not eligible
* Patients who have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) =\< 1
* Patients who are categorized under Barcelona-Clınic Liver Cancer (BCLC)-C stage
* Cirrhosis grade of Child-Pugh class A; Child-Pugh status should be calculated based on clinical findings and laboratory results during the screening period
* Platelet count \>= 60 x 10\^9/L
* Hemoglobin \>= 8.5 g/dL
* Total bilirubin =\< 2.5 mg/dl
* Alanine transaminase (ALT) and aspartate aminotransferase (AST) =\< 5 x upper limit of normal
* Serum creatinine =\< 1.5 x the upper limit of normal
* Prothrombin time (PT)-international normalized ratio (INR) =\< 2.3 or PT =\< 6 seconds above control
* All acute toxic effects of any prior treatment have resolved to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 grade 1 or less at the time of signing the informed consent form (ICF)
* Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug; post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
* Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 30 days after the last dose of study drug; the definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate
* Subject must be able to swallow and retain oral medication
Exclusion Criteria:
* Main portal vein thrombosis (PVT)
* Patients who are eligible for curative treatment (ablation or resection or transplantation)
* Previous or concurrent cancer other than HCC unless without evidence of disease for 5 or more years prior to entry, except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor
* Tumor replacement \> 70% of total liver volume based on visual estimation by the investigator OR tumor replacement \> 50% of total liver volume in the presence of albumin \< 3 mg/dL
* Contraindications to angiography and selective visceral arterial catheterization
* Any known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, uncontrolled hypertension or history of cardiac disease, significant gastrointestinal (GI) bleed within 30 days, metastatic brain disease, renal failure requiring dialysis
* Concomitant treatment or within 28 days of one of the following:
* Any other systemic anticancer agent other than agents used for cancer prevention
* Subjects who have used strong cytochrome P450 3A4 (CYP3A4) inducers (e.g., phenytoin, carbamazepine, phenobarbital, St. John's Wort \[hypericum perforatum\], dexamethasone at a dose of greater than 16 mg daily, or rifampin \[rifampicin\], and/or rifabutin) within 28 days before treatment
* UDP glycosyltransferase 1 family, polypeptide A1 (UGT 1A1) and UDP glycosyltransferase 1 family, polypeptide A9 (UGT 1A9) substrates (e.g., irinotecan)
* P-glycoprotein (Gp) substrates (e.g., Digoxin)
* Prior radiation therapy to the liver
* Prior systemic therapy for the treatment of HCC, including sorafenib
* Any history of symptomatic pulmonary compromise, such as chronic obstructive pulmonary disease
* Any prior intervention for, or ongoing compromise of, the ampulla of Vater or biliary-enteric anastomosis
* Clinically evident ascites (trace ascites on imaging is acceptable)
* Pregnant or breast-feeding patients
* A positive serum pregnancy test within 14 days prior to treatment in women of childbearing potential
* Uncontrolled hypertension (systolic pressure \> 140 mm Hg or diastolic pressure \> 90 mm Hg \[NCI-CTCAE v4.0\] on repeated measurement) despite optimal medical management
* Active or clinically significant cardiac disease including:
* Congestive heart failure-New York Heart Association (NYHA) \> class II
* Active coronary artery disease
* Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
* Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before treatment, or myocardial infarction within 6 months before treatment
* Evidence or history of bleeding diathesis or uncontrolled coagulopathy
* Subject with any pulmonary hemorrhage/bleeding event of NCI-CTCAE v4.0 grade 2 or higher within 4 weeks before treatment; any other hemorrhage/bleeding event of NCI-CTCAE v4.0 grade 3 or higher within 4 weeks before treatment
* Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) within 6 months of informed consent
* Presence of a non-healing wound, non-healing ulcer, or bone fracture
* History of organ allograft. (Including corneal transplant)
* Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulations given during the course of this trial
* Any malabsorption condition
* Inability to comply with the protocol and/or not willing or not available for follow-up assessments | 15,486 |
Study Objectives
The purpose of this study is to evaluate risk of cancer incidence and mortality associated with the use of REGRANEX (becaplermin) in patients with diabetes who are members of a U.S. Veterans Health Administration.
Conditions: Diabetes Mellitus, Foot Ulcer, Diabetic Foot, Diabetic Neuropathies
Intervention / Treatment:
OTHER: Becaplermin nonusers, DRUG: Becaplermin users
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patients with diabetic foot ulcers who are members of the U.S Department of Veterans Affairs Health Care System (VA)
Exclusion Criteria:
* History of cancer (including nonmelanoma skin cancer) prior to study entry | 8,082 |
Study Objectives
The main objective of this study is to evaluate the safety of VM206RY in subjects with expression of HER2 in breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
BIOLOGICAL: VM206DNA, BIOLOGICAL: VM206Ad
Location: Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Women, 20 years of age
* Stage 3 or 4 breast cancer
* Unresectable breast cancer with Expression of Her2 and one of the following criteria including
* Prior use of Her2-targeted therapies(Herceptin, Tykerb, taxane and capecitabine) but it was not responding, with Immunohistochemistry (IHC) 3+, or IHC 2+ and FISH+, or SISH+
* Patients received treatment that three times continuously Different chemotherapies but it was not responding, with Immunohistochemistry (IHC) 2+ and FISH- or SISH-, or Immunohistochemistry (IHC) 1+
* Prior use of six chemotherapies(Anthracycline, Taxane, Gemcitabine, Capecitabine, Vinorelbine, Cyclophosphamide) but it was not responding, with Immunohistochemistry (IHC) 2+ and FISH or SISH-, or Immunohistochemistry (IHC) 1+
* One or more measurable(or assessable) lesion of breast or metastatic site
* Spiral CT: ≥ 10mm diameter
* general measurement methods (CT, X-ray, MRI): ≥ 20mm diameter
* Life expectancy 6 months
* Signed informed consent
Exclusion Criteria:
* Prior use of breast cancer vaccine
* Active or history of cardiovascular diseases within the past 3 months: Active uncontrolled cardiac disease, including cardiomyopathy, CHF(NYHA Class III\~IV), and unstable angina, family history of congenital long QT syndrome or QT/QTc interval \>0.45 sec or torsade de points(TdP), and history of idiopathic ventricular tachycardia or ventricular fibrillation, LVEF \< 50%
* Patients with coronary artery disease (myocardial infarction, angina, etc.) or a history of coronary artery disease
* Patients who is required hospitalization by severe fever or required antibiotic treatment by serious infection
* Patients who is confirmed as CNS metastases. (Only, patient with stable brain metastases is permit. Among the patients who have not any symptom, do not see the progression before registered the last 2 month)
* History of prior malignancies other than breast cancer within the past 5 years
* Patients with an existing condition or a history of autoimmune disease or immunodeficiency disease
* ECOG score ≥ 3
* Patients with severe dysfunction in major organs
* Blood: WBC \< 3,000/㎕; Platelet \< 100,000/㎕; Hematocrit \< 30
* Liver: Total bilirubin ≥ 1.5 x ULN; ALT/AST ≥ 2.5 x ULN
* Kidney: Creatinine ≥ 1.5 x ULN
* Abnormal values of anti-nuclear Ab, anti-double-stranded DNA and C3, as judged by the investigator
* History of surgical procedure, chemotherapy, Herceptin treatment, corticosteroid therapy, immunosuppressant therapy or radiotherapy within the past 4 weeks
* HIV Ag/Ab, HBs Ag, HCV Ab or HTLV-1 Ab positive
* Psychotropic drug misuse/abuse or alcoholism
* Prior use of vaccine within the past 4 weeks
* Cumulative dose of prior doxorubicin \> 360 ㎎/㎡ or epirubicin \> 720 ㎎/㎡
* Women who is pregnant or breastfeeding and don't agree to use a contraceptive during the study period.
* Patients who have participated in clinical trials enrolled in this clinical trial within 4 weeks before. (Only patient, who has taken survey and DNA test without drug-treatment, has permit.)
* Patients who are ineligible to participate in this study, as judged by the investigator.
* Patients who prohibit administering GM-CSF and prior use of GM-CSF within the past 4 weeks.
* Patients who expect hypersensitivity to investigational product (VM206RY) or any component of product.
* Due to malignancy neoplasm, patients who require supplementary oxygen or has severe dyspnea at rest
* Patients with hypertension \[inadequately controlled hypertension (systolic \> 180 mm Hg or diastolic \> 100 mm Hg)\] or a history of hypertension | 20,457 |
Study Objectives
This trial studies how well strength training works in improving bone health, pain, and quality of life in patients with multiple myeloma. Weekly physical activity may improve bone recovery, reduce pain, and increase quality of life in patients with multiple myeloma.
Conditions: Plasma Cell Myeloma
Intervention / Treatment:
DEVICE: FitBit, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, OTHER: Resistance Training, BEHAVIORAL: STEPS to Enhance Physical Activity
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
* Have a diagnosis of multiple myeloma
* Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion
* Are able to understand and follow assessment and training procedures
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
* Current and symptomatic pathological fracture(s) or severely advanced instability of the musculo-skeletal system
* Acute bone instability as assessed by whole body low-dose computed tomography and evaluated by an experienced neuro- and spine surgeon
* Major comorbidities that would cause danger to the patient when participating in the study. Examples are cardiac or pulmonary and infectious diseases that would have a risk of progression if the patient took part in the study
* Unwilling or unable to follow protocol requirements
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention (comorbidities, myeloma symptoms, treatment side effects) | 40,391 |
Study Objectives
The purpose of this research study is to determine if the EGFR mutation can be detected in CTCs. CTCs are cancer cells that are shed from solid tumors and float freely in the bloodstream. A device called the CTC-chip has been developed to find CTCs in the blood of patients with cancer. This is an experimental device. Using this device, the investigators will test participants' blood to try and find CTCs with the EGFR mutation and compare them with the results from the biopsy your doctor has recommended. The long-term goal of this research is to develop a way to test for the EGFR mutation that is less invasive than a tumor biopsy.
Conditions: Non Small Cell Lung Cancer
Intervention / Treatment:
DEVICE: Circulating tumor cell chip
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Histologically confirmed NSCLC that is metastatic or unresectable
* Have agreed to undergo a clinically recommended invasive repeat tumor itssue biopsy
Exclusion Criteria:
- | 36,354 |
Study Objectives
Although colorectal cancer is a preventable and curable disease if early stage tumors are removed, it is still the fourth cause of cancer worldwide and the second leading cause of death in many industrialized countries. The 5-year survival is about 55% often due to a late detection. Then, the identification of sensitive and specific molecular markers is therefore a major challenge for early diagnosis and prognosis of this disease.
Preliminary work have reported variations in the expression of DMBT1 (deleted in malignant brain tumor 1), a glycoprotein co-secreted with mucins in the light of the glands, during several stages of colon carcinogenesis. The goal of this study is to study by mass spectrometry (MS), alterations in the repertoire of glycosylation of mucins from colorectal tumors of various stages, grades, and recurrence status.
Conditions: DMBT1 Protein, Human, Colorectal Cancer
Intervention / Treatment:
OTHER: Detection of the expression of DMTB1 by immunohistochemistry
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* for colon cancer: patients surgically treated for colorectal cancer at the Group of hospitals of the Catholic Institute of Lille.
* for adenomatous polyps : patients treated for adenomatous polyps at the Group of hospitals of the Catholic Institute of Lille.
* for controls: patients surgically treated for diverticular disease at the Group of hospitals of the Catholic Institute of Lille.
Exclusion Criteria:
* none | 30,717 |
Study Objectives
The overarching goal of the proposed research is to evaluate whether qualitative and quantitative parameters in real time contrast enhanced ultrasound (CEUS) can aid in assessing suspicious indeterminate cystic appearing breast masses and ultimately determine whether or not an ultrasound guided biopsy is necessary. The underlying hypothesis is that breast masses (given BIRADS 4) that lack enhancement on CEUS will have a benign histology obtained by ultrasound guided core biopsy and/or surgery. Then, in the future, these non-enhancing cystic lesions can be followed and do not need biopsy intervention.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Definity
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* \>18 years of age
* recommended for an ultrasound guided biopsy due to breast mass detection
Exclusion Criteria:
* \< 18 years of age
* prior history of breast cancer
* prior history of biopsy for that specific lesion
* any condition that would be a contraindication to the microbubble contrast agent used in CEUS such as pulmonary hypertension, 3cardiac shunts, and allergy to perflutren. | 31,360 |
Study Objectives
The primary objective of this study is to determine the dose limiting toxicity and maximum tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects (in evaluable cases) of E7389 in patients with solid tumors.
Conditions: Cancer
Intervention / Treatment:
DRUG: E7389
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria:
1. Patients with histologically or cytologically confirmed solid tumors.
2. Patients who have progressed on or following standard therapy and with no other treatment options.
3. Patients aged 20-74 when they give informed consent.
4. Patients having a performance status (PS) of Eastern Cooperative Oncology Group (ECOG) 0 or 1.
5. Patients who can stay at the hospital from the start of the study drug treatment to 2 weeks of the first cycle.
6. Patients having adequate function of major organs (bone marrow, liver, kidney and lungs):
(1) Neutrophil count 1,500/mm3 (2) Platelet count 100,000/mm3 (3) Hemoglobin 9.0 g/dL (4) Aspartate aminotransferase \[AST\] 2.5 times the upper limits of normal (ULN) in institute, unless related to liver involvement by tumor, in which case 5.0 times ULN (5) Alanine aminotransferase \[ALT\] 2.5 times ULN in institute, unless related to liver involvement by tumor, in which case 5.0 times ULN (6) Total bilirubin 1.5 times ULN in institute (7) Serum creatinine 1.5 times ULN in institute (8) Pulse oximeter oxygen saturation 90%
7. Patients with no adverse drug reactions (excluding alopecia, etc.) that were caused by the prior therapy or could influence the safety evaluation of the study drug.
The withdrawal periods required from the completion of the prior therapy to the start of the study drug therapy are as follows:
1. Chemotherapy (excluding oral 5-FU and molecular target drugs), surgical therapy, other study drugs: 4 weeks
2. Nitrosourea agents, mitomycin C: 6 weeks
3. Radiotherapy, endocrinotherapy, immunotherapy, oral 5-FU, molecular target drugs, blood transfusion, blood products, G-CSF and other hematopoietic factors: 2 weeks
8. Patients who give written informed consent.
9. Patients with an expected survival of longer than 3 months from the start of the study drug therapy.
Exclusion criteria:
1. Patients with systemic infection with a fever (38°C).
2. Patients with a large amount of pleural effusion, ascites and pericardial fluid requiring drainage.
3. Patients with brain metastasis with clinical symptoms.
4. Patients with serious complications: (1) Patients with uncontrollable cardiac disease such as ischemic heart disease and arrhythmia at a level of severity that needs to be treated (excluding left ventricular hypertrophy, mild left ventricular volume overload and mild right leg block that accompany hypertension) (2) Patients with myocardial infarction within 6 months prior to study entry (3) Patients with a complication of hepatic cirrhosis (4) Patients with interstitial pneumonia and pulmonary fibrosis (5) Patients with a bleeding tendency
5. Women who are pregnant or breastfeeding, or premenopausal women of childbearing potential.
Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Premenopausal women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test, or have not agreed to use adequate measures of contraception.
6. Fertile men who are not willing to use contraception or fertile men with a female partner who is not willing to use contraception.
7. Patients who have tested positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus surface antigen (HBsAg).
8. Patients who need continuous systemic steroid therapy during the study period.
9. Patients who need continuous use of phenytoin, carbamazepine, rifampicin and/or barbiturate which induces cytochrome P450 (CYP3A4), a drug-metabolizing enzyme, during the study period.
10. Patients who have received extensive radiation therapy (30% or more of bone marrow).
11. Patients who refused to receive a supportive therapy of blood transfusion by suppressing bone marrow.
12. Patients who are participating in other clinical studies.
13. Patients whom the investigator or subinvestigator has judged inappropriate for this study. | 13,451 |
Study Objectives
A study to evaluate the response of growth factor signatures (GFS) to a single dose of dalotuzumab in participants with triple negative (TN) or estrogen receptor (ER)-positive luminal B breast cancer. The primary hypothesis is that dalotuzumab will induce a decrease in the GFS in at least 40% of participants.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: dalotuzumab (MK0646)
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Participant has operable stage I-IIIa breast cancer of the following subtypes: (1) estrogen receptor (ER)-negative, progesterone receptor (PR)-negative, and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; (2) ER-positive tumor meeting one of the following criteria: histologic grade 3; histologic grade 2 and PR-negative; histologic grade 2 and Ki67 antigen ≥10%. Tumor is at least 2 cm in diameter as assessed by physical or radiographic exam
* Participant is female and ≥18 years of age
Exclusion Criteria:
* Participant is pregnant, breastfeeding or planning to become pregnant while in the study
* Participant has received prior chemotherapy, biological therapy or radiation
* Participant has participated in a clinical trial in the last 30 days
* Participant has a history of drug or alcohol abuse in the last year
* Participant is human immunodeficiency virus (HIV) positive. Patient has a history of Hepatitis B or C
* Participant has poorly controlled diabetes mellitus | 36,574 |
Study Objectives
This is a phase 1b/2, multicenter, open-label, basket trial to evaluate the safety of talimogene laherparepvec injected intrahepatically into liver tumors alone and in combination with systemic intravenous (IV) administration of pembrolizumab, in subjects with non-hepatocellular carcinoma (HCC) liver metastases from breast adenocarcinoma (BC), colorectal adenocarcinoma (CRC), gastroesophageal cancer (GEC), melanoma, non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (RCC) in Part 1 Group A, and subjects with HCC with and without viral hepatitis in Part 1 Group B (viral hepatitis is only applicable in combination setting), and to evaluate the efficacy and safety of intratumoral talimogene laherparepvec in combination with systemic pembrolizumab in subjects with advanced triple negative breast cancer (TNBC), hormone receptor positive breast cancer, CRC, cutaneous squamous cell carcinoma (CSCC), and basal cell carcinoma (BCC) in Part 2 Group A and subjects with HCC with and without viral hepatitis in Part 2 Group B. The objective of Part 1 is to evaluate the safety of intrahepatic injection of talimogene laherparepvec into liver tumors alone and in combination with systemically administered pembrolizumab for the non-HCC (Group A) and HCC (Group B) cohorts separately. Part 2 consists of 2-stage design to evaluate the efficacy and safety of talimogene laherparepvec in combination with systemic pembrolizumab. Efficacy and safety will be evaluated in each of the five non-HCC tumor types from Group A separately. Similarly, the efficacy and safety of the combination treatment will be determined for Group B HCC subjects. As of Protocol Amendment 6 (dated 26 October 2021), intrahepatic injections of talimogene laherparepvec and liver biopsies are no longer performed in this study. Enrollment for this study has stopped.
Conditions: Hepatocellular Carcinoma, Liver Metastases, Cutaneous or Subcutaneous Lymph Node, Liver Tumors
Intervention / Treatment:
DRUG: Talimogene Laherparepvec, DRUG: Pembrolizumab
Location: Korea, Republic of, Belgium, Austria, Germany, United States, Australia, Spain, Switzerland, Poland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SEQUENTIAL
Masking: NONE | Summary of Subject Eligibility Criteria:
Key Inclusion Criteria:
Subjects must be age ≥ 18 years at the time of informed consent. Subjects must have histologically or cytologically confirmed disease.
Part 1 is restricted to BC, CRC, GEC, melanoma, NSCLC, or RCC with liver metastases or HCC.
Part 2 Group A is restricted to advanced hormone receptor positive BC, CRC, TNBC, CSCC, and BCC with or without liver metastases.
* Part 2 Hormone receptor positive Breast Cancer Arm only: Histologically and/or cytologically confirmed diagnosis of estrogen receptor (ER) positive and/or progesterone receptor (PrR) positive breast cancer.
* Triple negative breast cancer: Histologically and/or cytologically confirmed diagnosis of ER negative, PrR negative, human epidermal growth factor receptor 2 (HER2)-Neu negative.
Part 2 Group B is restricted to HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
For HCC subjects with a diagnosis of hepatitis B, they must be on antiviral therapy for at least 4 weeks prior to enrollment and hepatitis B virus (HBV) viral load by real-time polymerase chain reaction (qPCR) must be \< 100 IU/mL. HCC subjects with past or ongoing hepatitis C infection must have completed treatment for hepatitis C at least 1 month prior to study enrollment and hepatitis C viral load must be undetectable; subjects with hepatitis B and C must fulfill the eligibility criteria for hepatitis B and hepatitis C. Subjects with unresectable locally recurrent TNBC are eligible.
Non-HCC subjects must have received at least 1 prior standard of care systemic anti-cancer therapy for their locally advanced or metastatic disease. For the combination cohorts (Cohorts 5 and 6 in Part 1) and Part 2, subjects with melanoma CSCC or NSCLC do not need to have received prior therapy. In Part 1, subjects must have measurable liver tumors and liver tumors that are suitable for injection. In Part 2, subjects must have measurable disease and cutaneous, subcutaneous, lymph node, or liver tumors suitable for injection. NOTE: as of Protocol Amendment 6 \[dated 26 October 2021\], intrahepatic injections of talimogene laherparepvec and liver biopsies are no longer performed in this study, enrollment for this study has stopped. Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1, and life expectancy should be approximately 5 months or more. Adequate hematological, renal, hepatic, and coagulation function is required. Liver function tests may be mildly abnormal but within the parameters. Child-Pugh score must be A.
Key Exclusion Criteria:
Subjects must not be candidates for surgery or locoregional therapy with curative intent or planned systemic anti-cancer therapy, with the exception of immunotherapy in the combination cohorts (Cohorts 5 and 6 in Part 1 and all subjects in Part 2). Liver tumors must not be estimated to invade approximately more than one-third of the liver. Liver tumor-directed therapy, hepatic surgery or major surgery, antibody-based therapy, or immunotherapy must not have been performed \< 28 days, chemotherapy \< 21 days, and targeted small molecule therapy or hormonal therapy \< 14 days prior to enrollment. Subjects must either (1) have no central nervous system (CNS) metastasis, or carcinomatous meningitis, or (2) if CNS metastasis is present, must have stable treated cerebral metastases. Subjects must not have symptomatic auto-immune disease or be symptomatically immunosuppressed. They must not have a history of solid organ transplantation. For non-HCC, there must not be acute or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. For HCC with prior hepatitis B and/or C infection, HBV and/or HCV viral load by qPCR must be undetectable, and they must not have had recent treatment within 12 weeks for HBV or HCV with certain antiviral medications in Part 1 Group B cohorts 1-5 and 6a, and Part 2 Group B HCC without viral hepatitis. For all patients in Part 1 and for patients in Part 2 where intrahepatic liver injection is planned (NOTE: as of Protocol Amendment 6 \[dated 26 October 2021\], intrahepatic injections of talimogene laherparepvec and liver biopsies are no longer performed in this study, enrollment for this study has stopped), there should be no macroscopic intravascular invasion of tumors into the main portal vein, hepatic vein, or vena cava. Subjects must not: have active herpetic skin lesions or prior complications of herpetic infection (eg, herpetic keratitis or encephalitis); require treatment with an antiherpetic drug; have received live-virus vaccination within 30 days of planned treatment start; have previous therapy with talimogene laherparepvec, oncolytic viruses, or tumor vaccine. Subjects in the combination treatment cohort must not have: a history or evidence of psychiatric, substance abuse, or any other clinically significant disorder; toxic effects of the most recent prior chemotherapy not resolved to grade 1 or less (except alopecia); or expected other cancer therapy while on study with the exception of local radiation to the site of bone or other metastasis for palliative treatment. Male subjects of reproductive potential in the combination treatment must be willing to use acceptable methods of effective contraception during treatment and through 4 months after the last dose of pembrolizumab. | 40,276 |
Study Objectives
This phase I trial studies the side effects and best dose of cisplatin in treating patients with stage IIIB-IV non-small cell lung cancer or tumors that have spread from where they started to the lung (metastasis). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cisplatin directly into the arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.
Conditions: Metastatic Malignant Neoplasm in the Lung, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Adult Soft Tissue Sarcoma, Stage IV Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Cisplatin, OTHER: Pharmacological Study
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Any biopsy or cytologically proven resectable or unresectable primary or secondary (metastatic) malignancy in the lung; this is defined as
* Tumors whose only remaining residual deposits are confined to the lungs OR
* Oligometastatic tumors with \> 80% of measurable tumor volume in the target lung In both of the above situations, no clinical evidence of central nervous system (CNS) metastases can exist; oligometastatic disease is difficult to define but would, as a guideline, have only 1-4 loci of disease established in 1-2 organ systems outside the affected lung; exceptions to these guidelines can occur, particularly in cases where sites of metastatic disease are equivocal or so minute that it would not exceed 20% of tumor volume
* Unresectable stage IV non-small cell lung cancer (NSCLC)
* Unresectable stage IIIB NSCLC
* Resectable metastatic sarcoma to lung (thoracoscopically resectable)
* Other malignancies that meet the criteria
* Eastern Cooperative Oncology Group performance status 0-1
* No oxygen needs (oxygen use per standard established criteria for oxygen requirements)
* Modified Borg dyspnea scale \< 5
* Six minute walk \>= 50% of the expected distance; this will not be used as exclusion criteria if due to a reason other than respiratory per judgment of physician e.g., pain
* Ambulatory and resting oxygen (O2) saturation \> 88%
* PPO (predicted post operative)\* forced expiratory volume in one second (FEV1) \>= 50% predicted
* PPO values should be calculated for each patient
* PPO \* diffusing capacity of the lung for carbon monoxide (DLCO) \>= 50% predicted
* PPO values should be calculated for each patient
* PPO \* vital capacity \>= 50% predicted
* PPO values should be calculated for each patient
* Granulocytes \> 1,500 ul
* Platelets \>= 100,000 ul
* Patients must sign a study-specific consent form prior to registration
* Tumor anatomy must allow the isolated lung suffusion in the judgment of the principal investigator (PI)
Exclusion Criteria:
* Uncontrolled intercurrent disease
* Prior chemotherapy for proven metastatic disease within 4 weeks
* Evidence of pulmonary toxicity from previous or ongoing chemotherapy
* Creatinine \> 1.5 mg/dL
* Liver enzymes \> 2 times upper normal
* Uncontrolled congestive heart failure (in judgment of the PI)
* Optional: ejection fraction \< 40% for clinical evidence of insufficient cardiac reserve (multi gated acquisition scan \[MUGA\] or echocardiogram \[ECHO\] will be done only if indicated in the judgment of the PI)
* Myocardial infarction or angina within past 6 months
* Contraindications to anticoagulation
* Hydration intolerance (e.g., uncontrolled congestive heart failure \[CHF\])
* Human immunodeficiency virus positive (HIV+) on antiretroviral therapy
* Pregnant or lactating
* Diffuse pulmonary fibrosis involving over 25% of the total lung parenchyma
* Previous radiation for thorax
* Metastatic sarcoma to lung that is not able to have tumors resected thoracoscopically
* Prior lung removal in the affected lung (would have decreased lung volume) | 39,529 |
Study Objectives
This study was designed to investigate the safety and immunogenicity of Chiron's investigational H. pylori (HP3) vaccine
Conditions: Helicobacter Pylori, Gastritis, Gastric Cancer, Gastroduodenal Ulcers, Lymphoma
Intervention / Treatment:
BIOLOGICAL: helicobacter pylori vaccine, BIOLOGICAL: helicobacter pylori vaccine, BIOLOGICAL: helicobacter pylori vaccine, BIOLOGICAL: helicobacter pylori vaccine, BIOLOGICAL: Placebo, BIOLOGICAL: helicobacter pylori vaccine, BIOLOGICAL: helicobacter pylori vaccine
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Healthy
* Ages 18-40
* Negative for H. pylori infection
* Contraception for females
Exclusion Criteria:
* Present or past H. pylori infection
* Medically significant gastroduodenal disease
* Recent corticosteroid use
* Bleed diathesis
* Use of antibiotics used to treat H. pylori infection | 21,201 |
Study Objectives
The purpose of this study is to assess the longterm safety and efficacy of the vaginal application of Gynoflor®, an extremely low dosed estrogen therapy with lactobacilli, on atrophic vaginitis in postmenopausal breast cancer patients who have been treated with aromatase inhibitors.
Conditions: Atrophic Vaginitis
Intervention / Treatment:
DRUG: Gynoflor
Location: Germany, Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Patients with breast cancer on non-steroidal AI therapy (AI therapy start at least 6 months ago, and are scheduled to receive them during the study)
2. Postmenopausal and age ≥52 with cessation of menses for at least 12 months
3. Age 52 - 75 years
4. Clinical symptoms of vaginal atrophy
5. Vaginal pH \> 5.0
6. Karnofsky score ≥80%
7. Signed Informed Consent Form together with contractual capability
Exclusion Criteria:
1. Local or systemic use of any other sexual hormones (estrogens, progestins, androgens), 6 months before and during study
2. Local or systemic use of phytoestrogens or products known for or taken to improve vaginal mucosal function, risk of vaginal infections, or vulvovaginal symptoms, 4 weeks before and during study
3. Local or systemic use of any other anti-infectives, 2 weeks before and during study
4. Use of any other vaginal medication, vaginal rinses and/or moisturizers, gels containing xylocain or other analgesic products to decrease pain during intercourse, 1 week before and during study
5. Known or suspected hypersensitivity or intolerance to the study medications, inclusive their excipients
6. Suspicion of or clinically manifest STDs (infections with Neisseria gonorrhoea, Chlamydia trachomatis, Treponema pallidum, genital herpes, Trichomonas vaginalis, genital condylomata, HIV)
7. Clinical evidence of vaginal infections requiring extra treatment
8. Any infections of the upper genital tract
9. Hysterectomy
10. Genital haemorrhage of unknown origin
11. Malignant or pre-cancerous conditions of the uterus, vulva and/or vagina (PAP smear less than 3 years ago)
12. Acute thrombophlebitis, thromboembolic disorders or a history of these disorders in association with previous use of oestrogen preparations
13. Abuse of alcohol or drugs
14. All chronic illnesses which could influence the absorption, distribution, biotransformation or elimination of the test preparation
15. Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient in significant risk, may confound the study result, or may interfere significantly with the patient's participation in the study
16. BMI lower than 18.5 or higher than 30
17. Patient on steroidal AIs (aromasin)
18. Vulvo-dermatological conditions (like Lichen sclerosus, Lichen rubrus, Psoriasis)
19. Genital prolapses
20. Endometriosis
21. Use of antibiotics or chemotherapeuticals which are harmful to lactobacilli
22. Participation of patient in another investigational drug study, with the exception of treatment optimisation studies with non-steroidal AIs
23. Previous participation in this study
24. Patient is a relative of, or staff directly reporting to the investigator
25. Patient is an employee of the sponsor | 38,805 |
Study Objectives
This phase I trial studies the effects and safety of adding azacitidine (5-AzaC) to the standard of care (Soc) for patients with relapsed acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) after being treated with donor stem cell transplant. SoC includes giving an infusion of the donor's white blood cells (donor lymphocyte infusion or DLI) to boost the anticancer effects of the transplant. Giving 5-AzaC after DLI may alter the function of T-cells resulting in reduced incidence of graft versus host disease (GVHD) while maintaining the anticancer effects.
Conditions: Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: Azacitidine, DRUG: Pre-DLI Salvage Chemotherapy, BIOLOGICAL: Donor Leukocyte Infusion (DLI)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | PATIENT Inclusion Criteria:
* Must have a diagnosis of AML/MDS based on 2008 World Health Organization (WHO) classification of myeloid malignancies
* Must have laboratory, histologic, or cytogenetic evidence of disease relapse after allogeneic hematopoietic stem cell transplant (HSCT) and require salvage therapy followed by DLI
* Must have original donor
* Must have life expectancy \>= 2 months
* Must be ≥ 18 years old. Azacitidine is not approved by the FDA for use in children
* Must have an Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
* Must have laboratory results indicating:
* Total bilirubin \< 2.0 mg/dL
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 X the upper limit of institutional normal
* Serum creatinine =\< 2.0 mg/dL
* Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
* The effects of 5-AzaC on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because category D agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of childbearing age must have a negative serum pregnancy test (Beta \[B\]-human chorionic gonadotropin) within 72 hours prior to initiating therapy and be willing to not become pregnant by using effective contraception while undergoing treatment and for at least 3 months afterwards; azacitidine is a pregnancy category D drug and could be harmful to or cause loss of a fetus; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Men must be willing not to father a new child while receiving therapy; they must use an effective barrier method of contraception during the study and for 3 months following the last dose
* Both men and women and members of all races and ethnic groups are eligible for this trial
DONOR Inclusion Criteria:
* Must be the original donor for the allogeneic bone marrow transplant patient
* Must have signed the standard informed consent form; if sufficient cryopreserved cells remain from a previous donation, no additional donation or consent is required
* Must be eligible according to Washington University "Guidelines for Eligibility of Normal Donors" or per National Marrow Donor Program (NMDP) standards if unrelated donor
* Both men and women and members of all races and ethnic groups are eligible for this trial
PATIENT Exclusion Criteria:
* Must not have Grade III-IV GVHD
* Must not have an advanced malignant hepatic tumor
* Must not receive anti-thymocyte globulin, campath (alemtuzumab) or daclizumab within 4 weeks of DLI
* Must not receive any other forms of chemotherapy after cell infusion during the treatment protocol
* Must not be receiving any other investigational agents within 14 days of first dose of study drug
* Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
* Must not be pregnant or breastfeeding; pregnant women are excluded from this study because azacitidine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with azacitidine, breastfeeding should be discontinued if the mother is treated with azacitidine; these potential risks may also apply to other agents used in this study
* Must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine or other agents used in the study
* Must not have a known or suspected hypersensitivity to azacitidine or mannitol.
* Must not be human immunodeficiency virus (HIV)-positive and on combination antiretroviral therapy; these patients are ineligible because of the potential for pharmacokinetic interactions with azacitidine; in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
DONOR Exclusion Criteria:
* Must not have any underlying conditions which would contra-indicate apheresis
* Must not be pregnant | 42,792 |
Study Objectives
This study will investigate the effects and side effects of BAY 43-9006 in patients with advanced, recurrent, or refractory non-small cell lung cancer (NSCLC). BAY 43-9006 is one of a new class of anticancer agents known as bi-aryl ureas.
Patients 18 years of age and older with NSCLC that has recurred or progressed after one regimen of chemotherapy may be eligible for this study. Candidates are screened with a medical history and physical examination; blood tests; tumor biopsy (see below); chest x-ray; electrocardiogram; and imaging studies, including positron emission tomography-computed tomography (PET-CT, see below) and dynamic, contrast-enhanced MRI (DCE-MRI, see below).
Participants take BAY 43-9006 by mouth twice a day, morning and evening. On the first and 15th days of treatment, patients are admitted to the hospital for pharmacokinetic studies; that is, a test of how the body handles the drug. For the test, blood is collected at intervals (at 15 minutes, 30 minutes, and 1, 2, 4, 6, 8, 12 and 24 hours after ingestion) to determine the drug's level in the bloodstream. Treatment with BAY 43-9006 continues until the study doctor determines that the medication is not beneficial or the patient wishes to withdraw from the study.
In addition to drug therapy, patients undergo the following tests and procedures:
* Physical examination every 4 weeks
* Blood pressure checks once a week during the first 4 weeks
* Blood tests every week
* CT scans or other imaging tests, such as ultrasound or MRI, every 8 weeks to evaluate the tumor's response to treatment. CT is an x-ray test that provides detailed pictures of the inside of the body. It can be done from different angles, providing a 3-dimensional picture of the part of the body being studied and allowing the doctor to see the location, nature, and extent of disease. MRI uses a powerful magnet and radio waves instead of x-rays to produce accurate, detailed pictures of organs and tissues.
* PET-CT approximately every 8 weeks to look at how different parts of the body take up and use glucose (a sugar nutrient). Because rapidly growing cells, such as tumors, use more sugar than normal cells do, this test can be used to detect cancer. For the test, the patient is given an injection of a sugar solution in which a radioactive tracer has been attached to the sugar molecule. A special camera detects the radiation emitted by the solution, and the resulting images show how much sugar is being used in various parts of the body. PET-CT uses the PET scan in combination with standard CT in a machine that does both tests.
* DCE-MRI after 2 weeks of treatment. This test uses MRI with a special non-radioactive dye to examine blood flow in a certain part of the body.
* Tumor biopsy (optional) after 2 weeks of treatment. A biopsy is the surgical removal of a small piece of tissue. The tumor biopsy is done either using a small bore needle under CT guidance or by direct visualization using a laparoscope/thoracoscope. For the needle biopsy, a needle is inserted through the skin and guided by CT into the tumor mass. For the laparoscopy/thoracoscopy, the patient is sedated or asleep and small lighted tubes are inserted into small holes made in the skin. The tumor is located and tissue withdrawn.
Conditions: Non-Small-Cell Lung Carcinoma
Intervention / Treatment:
DRUG: BAY 43-9006 (Sorafenib)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | * INCLUSION CRITERIA:
Histologically documented Non-small cell lung cancer and confirmed by the Laboratory of Pathology at the Clinical Center/National Institutes of Health (NIH) or the Laboratory of Pathology at National Naval Medical Center (NNMC).
Recurrent or progressed Non-Small Cell Lung Cancer (NSCLC).
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as greater than 20 mm with conventional techniques or as greater than 10 mm with spiral Computed tomography (CT) scan.
Patients must have recovered from toxicity related to prior therapy to at least to grade 1 (defined by Common Terminology Criteria for Adverse Events (CTCAE) 3.0) and must not have had prior chemotherapy within 4 weeks. Patients must be at least 28 days since any prior radiation or major surgery.
Age greater than 18 years (males or non-pregnant females). Because no dosing or adverse event data are currently available on the use of BAY 43-9006 in patients less than 18 years of age, children are excluded from this study but will be eligible for future pediatric single-agent trials, if applicable.
Life expectancy of greater than 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status less than 2 (Karnofsky \> 60%).
Patients must have adequate organ and marrow function (as defined below). Patients must have returned to base line or grade one from any acute toxicity related to prior therapy.
Leukocytes greater than 3,000/micro l;
Absolute neutrophil count greater than 1,200/micro l;
Platelets greater than 100,000/micro l;
International normalized ratio (INR) less than or equal to 1.2
Partial thromboplastin time (PTT) less than or equal to 36 seconds or abnormality can be explained by the presences of lupus anticoagulant
Total bilirubin less than or equal to 1.5 times the institutional upper limits of normal;
Aspartate aminotransferase, oxaloacetic transaminase (AST,SGOT) and alanine transaminase, serum glutamic pyruvic transaminase (ALT,SGPT) less than 2.5 times the institutional upper limits of normal;
Creatinine or creatinine clearance less than or equal to 1.5 times the institutional upper limits of normal or greater than 45 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal.
The effects of BAY 43-9006 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because kinase inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and continue for at least 2 months after completion. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BAY 43-9006, breastfeeding should be discontinued if the mother is treated with BAY 43-9006.
Ability to comply with daily oral self administration schedule, and the ability to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
Patients with symptomatic brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, patients who have had treatment for their brain metastases and whose brain metastatic disease status has remained stable for at least 3 months without steroids may be enrolled at the discretion of the principal investigator.
Uncontrolled medical illness including, but not limited to, ongoing or uncontrolled, symptomatic congestive heart failure (American Heart Association (AHA) Class II or worse), uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Human immunodeficiency virus (HIV)positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with BAY 43-9006. HIV positive patients not receiving antiretroviral therapy are excluded due to the possibility that BAY 43-9006 may worsen their condition and the likelihood that the underlying condition may obscure the attribution of adverse events with respect to BAY 43-9006.
Patients may not be receiving any other investigational agents.
History of another invasive malignancy in the last five years. Non-invasive, non-melanoma skin cancers will be allowed.
Patients with conditions that would impair their ability to swallow tablets are excluded.
Patients must not have any evidence of bleeding diathesis.
Patients must not be on therapeutic anticoagulation. Prophylactic anticoagulation (i.e. low dose warfarin) of venous or arterial access devices is allowed provided that the requirements for prothrombin time (PT), international normalized ratio (INR) or partial thromboplastin time (PTT) are met.
Both men and women and members of all races and ethnic groups are eligible for this trial. Every effort will be made to recruit women and minorities in this study. | 38,838 |
Study Objectives
The main objective is to evaluate the impact of the recruitment and training of a peer-navigator on the participation rate of colorectal cancer screening among underserved area. The role of the navigator is to establish an intervention culturally-tailored to the inhabitants in order to promote the Fecal Occult Blood test (FOBT) and accompany the inhabitants to complementary exams, if needed.
Conditions: Healthy
Intervention / Treatment:
BEHAVIORAL: Navigator intervention
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* person living in the IRIS intervention zones
* person invited by the local management structure to participate in colorectal cancer screening
Exclusion Criteria:
* person not living in the IRIS intervention zone
* person not invited by the local management structure to participate to colorectal cancer screening | 1,024 |
Study Objectives
Loop formation is the most frequent cause of cecal intubation failure during colonoscopy. To reduce the loop formation, external abdominal pressure is widely used and proved to be helpful. Properly applied pressure can also decrease patients discomfort and shorten the cecal intubation time.
The loop formation during water exchange is less severe as compared with during air insufflation and can be reduced quite readily. Traditionally an assistant is not asked to administer abdominal compression until the endoscopist has struggled for some time and failed to reduce the loops by withdrawal. The colonoscopist can administer the abdominal compression whenever the scope is not advancing smoothly, probably in the early stage of loop formation. We test the hypothesis that colonoscopist administered abdominal compression to remove loops in their early stage of formation hastens cecal intubation.
A total of 120patients will be randomized in a 1:1 ratio (n=60 per group). When the tip of the scope doesn't advance or paradoxical movements occur, loop reduction by withdrawal of the scope will be implemented. If looping persists, abdominal compression will be applied. In the endoscopist-administered abdominal compression (endoscopist) group, the colonoscopist will apply the compression with his right hand and counter the pressure by pushing the back of the patient with his left forearm with the colonoscope in his left hand. The compression will be administered at left lower quadrant when the scope is in the sigmoid colon and at left lower quadrant and upper abdomen, respectively, when the scope tip reaches the transverse or ascending colon. If the formation of loop cannot be overcome, an assistant will apply the abdominal compression instead. In the assistant-administered abdominal compression (assistant) group, an endoscopic assistant will apply abdominal compression when a loop is formed. The assistant will apply the compression at the left lower quadrant initially, but quickly shift to other parts as needed depending on the tip location of colonoscope. If manual compressions fail, then the patients' position will be changed.
Conditions: Colonic Polyp, Colonic Adenoma
Intervention / Treatment:
PROCEDURE: endoscopist-administered abdominal compression, PROCEDURE: assistant-administered abdominal compression
Location: Taiwan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE | Inclusion Criteria:
* In the Buddhist Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Chiayi, Taiwan.
* Patients who undergo WE colonoscopy performed by the two endoscopists (YHH and CWT) at the endoscopic suite will be included.
Exclusion Criteria:
* Included patient declined to give consent,
* age \<20 years old,
* age \>80 years old,
* previous partial colectomy, not completely consumed bowel prep regimen, massive ascites, or known colonic obstruction, morbid obesity (BMI ≥ 35). | 43,067 |
Study Objectives
This study aimed to determine whether registrar involvement in minimally invasive distal pancreatectomy (MIDP) was associated with adverse outcomes.
Conditions: Minimally Invasive Distal Pancreatectomy
Intervention / Treatment:
PROCEDURE: Minimally invasive distal pancreatectomy
Location: France
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion criteria:
- Patients who underwent minimally invasive distale pancreatectomy for benign or borderline pathology between 2009-2020
Exclusion criteria:
* open distal pancreatectomy
* minimally invasive distal pancreatectomy for pancreatic cancer
* 20 first consecutive patients operated on by the consultant (learning curve) | 19,753 |
Study Objectives
The purpose of this study is to test a new approach to the use of standard drugs before surgery in patients with lung cancer. This study will find out what effects, good and/or bad, that this approach has on the cancer.
It is routine to give chemotherapy prior to surgery in patients with this type of lung cancer, to help keep it from coming back. It is also routine to perform a special type of scan called a PET scan. This PET scan measures how active a cancer is by use of a special tracer made out of sugar. In this study, all patients will have a PET scan and then be treated with standard chemotherapy drugs, either pemetrexed and cisplatin if the cancer is a "non-squamous" cancer or gemcitabine and cisplatin if the cancer is a squamous cancer. In rare cases, the doctor will decide to give carboplatin instead of cisplatin. In most patients, a repeat PET scan will show that the tumor is decreasing and they will complete standard chemotherapy then go on to have surgery.
In some patients, a repeat PET scan will show that the tumor has not decreased enough. For these patients, the routine practice is to proceed with surgery. This research study will test whether switching from the standard treatment of pemetrexed and cisplatin or gemcitabine and cisplatin to a different treatment called vinorelbine and docetaxel is safe and effective. Vinorelbine and docetaxel are also standard chemotherapy drugs which work in a different way than pemetrexed or gemcitabine and cisplatin.
Conditions: Lung Cancer
Intervention / Treatment:
DRUG: pemetrexed, DRUG: cisplatin, DRUG: Carboplatin, DRUG: Gemcitabine Hydrochloride, DRUG: Vinorelbine Tartrate, DRUG: Docetaxel
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Pathologic confirmation of NSCLC at MSKCC
* Stages IB, IIA, IIB, IIIA or IIIB NSCLC
* Primary tumor must measure ≥ 2 cm on CT imaging (per PERCIST guidelines)
* Primary tumor must be FDG-avid with an SUVmax \>4.5 (to be consistent with PERCIST guidelines)
* Patients must be candidates for resection with curative intent
* Age ≥ 18 years
* Karnofsky performance status ≥ 70%
* Normal bone marrow function
* leukocytes ≥ 3,000/μl
* absolute neutrophil count ≥ 1,500/μl
* platelets ≥100,000/μl
* hemoglobin ≥9gm/dl.
* Adequate hepatic function
* Total bilirubin ≤1.5 x ULN
* AST ≤ 1.5 x UNL, ALT ≤ 1.5 x ULN
* Alkaline phosphatase ≤ 1.5x ULN
* Women of childbearing age must have a negative pregnancy test
* Men and women of childbearing potential must be willing to use effective contraception while on treatment and for at least 3 months thereafter
* Patients must have the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients must not be receiving any other investigational agents
* History of myocardial infarction or unstable angina within the past 12 months Patients with peripheral neuropathy \> grade 1
* Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection.
* Patients with diabetes mellitus requiring insulin therapy (per PERCIST guidelines)
* Patients with third space fluid which cannot be adequately controlled with drainage
* Women who are pregnant or breast-feeding
* Psychiatric illness or social situation that would limit compliance with study requirements
* Patients with known HIV infection requiring antiretroviral medications and those with AIDS
* Baseline subjective hearing deficit, even if it does not require a hearing aid or intervention, or interfere with activities of daily living (CTCAE grade 2 or higher)
* Baseline renal function \<60 ml/min as calculated by the equation of Cockcroft and Gault using the patient's age, weight (kg), and serum creatinine (mg/dl).
* Congestive heart failure with New York Heart Association functional classification \> II, characterized by fatigue, dyspnea or other symptoms which limit activities of daily life.
Selection of Pemetrexed versus Gemcitabine: Patients treated with pemetrexed must meet all of the following criteria:
* Non-squamous histology
* Patients must have the ability to interrupt non-steroidal anti-inflammatory drugs (NSAIDs) 2 days before (5 days for long-acting NSAIDs), the day of, and 2 days following administration of pemetrexed
* Patients must have the ability to take folic acid, Vitamin B12, and dexamethasone according to protocol
* Patient refuses to take cisplatin | 40,490 |
Study Objectives
Limited data exists for the cancer patients' preferences on their patient-doctor interaction with their radiation oncologist. These physicians have the opportunity to develop intimate relationships with their patients since these patients typically require daily radiation treatments anywhere from one to seven weeks. Thus, by having a greater understanding of the individual patient preferences, the radiation oncologists will be able to better serve their patients leading to improved patient satisfaction with their physician and healthier outlook on life. This is the premise and the hypothesis of this study.
Conditions: Breast Cancer, Prostate Cancer, Lung Cancer
Intervention / Treatment:
BEHAVIORAL: Physician behavior related to Patient Preference Survey, OTHER: Patient Preference Results
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: OTHER
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:Any Patient/subject (adult male or female) with prostate or breast or lung cancer (Primary or Metastatic) who is scheduled to receive radiation therapy at one of the UPMC Cancer Centers
* Patient/subject must receive radiation treatment in addition to consultation with the Radiation Oncologist
* Patient/subject must meet with radiation oncologist at least one day per week while receiving radiation therapy.
* Any attending radiation oncologist whose patient is enrolled in this study
Exclusion Criteria:
* Patient/subject under age 18 If subject previously underwent this study, even if the previous study was for a different diagnosis. Subjects can only undergo this study once.
Patients/subjects who do not have the functional and mental capacity to independently answer the questionnaire. | 2,647 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells.
PURPOSE: Randomized phase III trial to study the effectiveness of tamoxifen, octreotide, and chemotherapy in treating women who have stage I or stage II breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: cyclophosphamide, DRUG: doxorubicin hydrochloride, DRUG: octreotide pamoate, DRUG: tamoxifen citrate
Location: Canada, United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS: Histologically confirmed Stage I, IIA or IIB invasive adenocarcinoma of the breast with T1-3, pN0 and M0 classification Must have undergone total mastectomy or lumpectomy followed by an axillary dissection or sentinel node resection if participating in NSABP B-32 Histologically negative axillary lymph nodes OR Histologically negative sentinel lymph nodes if participating in NSABP B-32 Lumpectomy and axillary dissection acceptable only if margins of resected specimen are histologically free of invasive tumor or ductal carcinoma in situ and other dominant masses within the ipsilateral breast remnant are histologically confirmed to be benign Additional operation after resection is allowed in order to obtain clear margins No bilateral malignancy of the breast ER positive tumors as defined by at least one of the following: At least 10 fmol/mg cytosol protein by either dextran-coated charcoal or sucrose density gradient methods Positive or not definitely negative results by the enzyme immunoassay method (EIA) or by immunocytochemical assay No more than 63 days from time of initial cytologic or histologic diagnosis of breast cancer till randomization No bone metastases (confirmation must be made for those with skeletal pain) Tumor must be no greater than 5 cm in its greatest dimension for patients who are treated by lumpectomy and axillary dissection Hormone receptor status: Estrogen receptor positive
PATIENT CHARACTERISTICS: Age: Not specified Sex: Female Menopausal status: Not specified Life expectancy: At least 10 years (excluding diagnosis of cancer) Performance status: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count postoperative at least 100,000/mm3 Hepatic: Bilirubin normal SGOT/SGPT normal Renal: Creatinine normal Cardiovascular: No cardiac disease that would preclude the use of doxorubicin (for patients who are to receive adjuvant chemotherapy in this study), including: Myocardial infarction Angina pectoris that requires antianginal medication History of congestive heart failure Arrhythmia associated with concurrent heart failure or cardiac dysfunction Valvular disease with cardiac compromise Cardiomegaly or ventricular hypertrophy unless left ventricular function is within normal limits Poorly controlled hypertension Other: No prior invasive breast cancer or ductal carcimoma in situ No systemic disease that would preclude patients from any part of study No history of symptomatic gallbladder or biliary tract disease unless patient has undergone cholecystectomy No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude No prior nonbreast malignancies in past 10 years except: Squamous or basal cell carcinoma of the skin that has been effectively treated Carcinoma in situ of the cervix that has been treated by operation only Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by segmented resection only No psychiatric or addictive disorders Not pregnant or nursing Negative pregnancy test
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for breast cancer Chemotherapy: No prior chemotherapy for breast cancer No prior anthracycline therapy for patients who are to receive adjuvant chemotherapy in this study Endocrine therapy: No prior endocrine therapy for breast cancer Must discontinue any sex hormonal therapy before prior to and during study Radiotherapy: No prior radiotherapy for breast cancer No breast radiation therapy before randomization for patients who receive lumpectomy Surgery: See Disease Characteristics At least 2 weeks since last surgical procedure Other: No concurrent cyclosporine therapy No concurrent heparin or warfarin anticoagulation therapy | 23,034 |
Study Objectives
A multicentre, observational, retrospective study to analyse the efficacy of high dose isofosfamide thorugh elastomer in patients with relapsed/ refractory osteosarcoma
Conditions: Osteosarcoma Recurrent
Intervention / Treatment:
OTHER: Observational study
Location: Italy
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Diagnosis of high risk relapsed/ refractory osteosarcoma
* Aged \<= 40 years at the beginning of treatment
* at least one completed cycle of HD IFO through elastomer (14g/mq) in 14 days
* disease evaluation according to RECIST criteria v.1.1
Exclusion Criteria:
* none | 22,780 |
Study Objectives
The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has HER2+ breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Taxotere, DRUG: Cytoxan, DRUG: Herceptin
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
A woman will be eligible for inclusion in this study if she meets all of the following criteria:
* Has HER2+ (IHC staining of 3+ \[uniform, intense membrane staining of \>30% of invasive tumor cells\], or a FISH result of .6 HER2 gene copies per nucleus or a FISH ratio \[HER2 gene signals to chromosome 17 signals\] of \>2.2; patients with equivocal FISH ratio results 1.8-2.2 are also eligible if 3+ IHC) (Appendix IX); Stage I, IIA, IIB, or IIIA T1-3N1-3M0 disease. At the discretion of the Treating Physician, patients with 4+ nodes with other factors such as patient choice, older age, preexisting cardiac disease with normal MUGA or ECHO may be enrolled into a separate subgroup.
* Has operable, histologically confirmed, invasive carcinoma of the breast.
* Has known ER and PR status
* Has adequate tumor specimen available for FISH analysis of TOP2A status (See Appendix VII)
* Has had no prior chemotherapy unless it was given \>5 years ago for breast cancer or other cancer
* Has an ECOG Performance Status (PS) 0-1
* Age \>18 to \<70 years old.
* Has laboratory values of: See protocol for specific details
* Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) and alkaline phosphatase (ALP) within the ranges shown below. In determining eligibility the more abnormal of the 2 values (AST or ALT) should be used. See protocol for specific details
* Has complete surgical resection of the primary breast tumor: either lumpectomy or mastectomy with sentinel lymph node or axillary dissection.
* It has been \<84 days since the date of definitive surgery, and there is adequate wound healing as determined by the Treating Physician
* Has no evidence of metastatic disease by physical examination and x-ray; appropriate scans as needed by each individual patient (eg, bone scan; abdominal, chest CT; PET or PET/CT; ultrasound; or MRI should indicate no evidence of metastatic disease.
* Has normal cardiac function as evidenced by a LVEF \>50%, but must be within normal limits (WNL) by institutional standard, as determined by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO). The same modality must be used throughout the study to evaluate LVEF. Ejection fraction (EF) as determined by ECHO must be WNL by institutional standard.
* Has a negative serum pregnancy test within 7 calendar days prior to registration (female patients of childbearing potential \[not surgically sterilized and between menarche and 1 year postmenopause\]).
* If fertile, patient has agreed to use an acceptable method of birth control (barrier contraceptive) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter
* Has signed a Patient Informed Consent Form
* Has signed a Patient Authorization Form
Exclusion Criteria:
A woman will be excluded from this study if she meets any of the following criteria:
* Has any evidence of disease following complete surgical resection of the primary tumor and metastatic workup
* Has Stage IIIB breast cancer (T4 disease; ie, patients with fixed tumors, peau d'orange skin changes, skin ulcerations, or inflammatory changes).
* Has Stage IV breast cancer (M1 disease on TNM staging system)
* Had prior chemotherapy for breast cancer or other cancer within the last 5 years (no neoadjuvant chemotherapy in this study is permitted)
* Has a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
* Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA) Class II or greater heart failure (see Appendix III), uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic changes
* Has abnormal baseline MUGA (or ECHO) (\<50%, or less than institutional LLN)
* Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Adjuvant hormonal therapy, if needed, may be given during radiation therapy and during treatment with trastuzumab after completion of chemotherapy.
* Is receiving concurrent investigational therapy or has received such therapy within the past 30 calendar days
* Has peripheral neuropathy \>Grade 1
* Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious viral (including clinically defined AIDS), bacterial or fungal infection; or history of uncontrolled seizures, or diabetes, or CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
* Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
* Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
* Is an obese patient to whom the Treating Physician would not be comfortable administering full doses of study drugs as calculated by the BSA. Obese patients will be treated based on actual body weight. Obese patients treated with full doses based on actual BSA are eligible
* Is a pregnant or breastfeeding woman
* Is deemed unable to comply with requirements of study | 35,430 |
Study Objectives
The purpose of this study is to prospectively asses established biomarkers in the diagnosis and prognosis of patients and will include assessment of a number of biomarkers, genomics and proteomics.
Conditions: Respiratory Disease, Pleural Effusion, Lung Cancer
Intervention / Treatment:
Location: United Kingdom
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Undiagnosed pleural effusion or pleural thickening requiring investigation by one of the following:
* Pleural aspiration
* Pleural biopsies from medical thoracoscopy or
* Ultrasound guided biopsies as part of the clinical plan
* Suspected lung cancer undergoing bronchoscopy and biopsies.
Exclusion Criteria:
* Inability to give written informed consent
* Inability to obtain pleural fluid, blood, endobronchial or pleural biopsies as applicable | 24,897 |
Study Objectives
The purpose of this study is to find out if a new drug, LDE225, is safe and has beneficial effects when combined with paclitaxel in women with platinum resistant ovarian cancer. Platinum resistant ovarian cancer refers to recurrent ovarian cancer that has undergone chemotherapy inclusive of a platinum compound (e.g. carboplatin or cisplatin).
Conditions: Recurrent Ovarian Cancer
Intervention / Treatment:
DRUG: LDE225
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma Histologic confirmation of the original primary tumor is required
* Papillary serous, endometrioid, clear cell, undifferentiated and mixed histologies
* Platinum resistant or refractory disease as per standard clinical and Gynecologic Oncology Group definition. Patients have had a treatment-free interval of less than 6 months from last platinum-based treatment to recurrence or progression during platinum based therapy
* Patients must have received at least one-prior platinum based chemotherapy regimen, to include cisplatin, carboplatin or other organoplatinum compound, for treatment of primary or recurrent ovarian, fallopian tube or primary peritoneal cancer
* Patients must have received a taxane as part of their prior treatment
* Measurable disease is required. By definition, measurable disease is at least one lesion that can be accurately measured in at least one dimension with the longest dimension to be recorded. Each lesion must be ≥ 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, MRI or ≥ 10 mm when measured by spiral CT imaging
* Patients must have one target lesion to be utilized in order to assess response per RECIST criteria
* ECOG Performance statuses of 0, 1, or 2
* Adequate organ function as evidenced by:
1. Hematology: WBC ≥3.0 x 10\^9/L; ANC ≥1.5 x 10\^9/L; Platelets ≥100 x 10\^9/L
2. Renal function: Creatinine less than or equal to 1.5 x institutional upper limit of normal (ULN) or 24-hour clearance greater than or equal to 50 mL/min
3. Hepatic function: Bilirubin ≤ 1.5 x ULN and ALT, SGOT and alkaline phosphatase ≤ 2.5 x ULN
4. Plasma creatine phosphatase (CK) less than 1.5 x ULN
5. Serum creatinine less than or equal to 1.5 x ULN or 24-hour clearance greater than or equal to 50 mL/min
* Signed informed consent.
* Female patients of any ethnic group. Female patients must be surgically sterile, postmenopausal (no menses for at least one year), or using medically approved method of contraception (excluding rhythm, withdraw or abstinence)
* Age greater than or equal to 19
* Recovery from effects of any recent surgery, chemotherapy and/or radiation
1. No evidence of active infection requiring antibiotic therapy
2. Hormonal therapy being utilized, as an anti-neoplastic treatment must be discontinued at least one week prior to study entry. Hormonal replacement therapy for symptom management is allowed
3. Any prior therapy directed at the malignancy including biologic or immunologic agents, must have be discontinued at least three weeks prior to study entry
Exclusion Criteria:
* Patients with pathology demonstrating mucinous, carcinosarcoma or low malignant potential tumor histology are excluded. In addition, non-ovarian malignancies, malignant germ cell or stromal tumors are also excluded
* Previous or concurrent malignancies at other sites within the last 5 years, with the exception of in situ carcinoma of the cervix and adequately treated basal cell carcinoma or squamous cell carcinoma of the skin. In addition, patients with prior or concomitant, based on hysterectomy, Stage IA endometrial adenocarcinoma with less than 3 mm depth on invasion, absence of lymphovascular space invasion and absence of grade 3, papillary serous or clear cell histology are allowed
* Patients with prior radiation to the abdominal cavity or pelvis are excluded
* Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract or known malabsorption syndromes
* Patients who have previously been treated with systemic sonidegib (LDE225) or with other Hh pathway inhibitors
* Serious concomitant illness including but not limited to: uncontrolled diabetes mellitus, dementia, active infection (including HIV infection) requiring IV or oral antibiotics and psychiatric illness and/or other uncontrolled medical conditions which may preclude compliance with study protocol
* Patients who have neuromuscular disorder (e.g. inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis and spinal muscular atrophy) or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as HMG CoA inhibitors (statins), clofibrate and gemfibrozil, and the cannot be discontinued at least 2 weeks prior to starting sonidegib treatment. If it is essential that the patient remain on a statin to control hyperlididemia, only pravastatin may be used with extra caution
* Patients who are planning on embarking on a new strenuous exercise regimen after initiation of study treatment. Muscular activities, such as strenuous exercise, that can result in significant increases in plasma CK levels should be avoided whilst on sonidegib treatment
* Patients who have taken part in an experimental drug study within 4 weeks or 5 half-lives, whichever is longer, of initiating treatment with sonidegib
* Patients who are receiving other anti-neoplastic therapy (e.g. chemotherapy, targeted therapy or radiotherapy) concurrently or within 2 weeks of starting treatment with sonidegib
* Peripheral Neuropathy of NCI-CTC (National Cancer Institute-Common Toxicity Criteria) grade greater than or equal to 2
* Impaired cardiac function or clinically significant heart disease, including any one of the following:
1. Angina pectoris within 3 months
2. Acute myocardial infarction within 3 months
3. QTcF \> 470 msec on the screening ECG
4. A past medical history of clinically significant ECG abnormalities or a family history of prolonged QT-interval syndromes
5. Other clinically significant heart disease (e.g. congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (\>5 mIU/mL)
* Patients who are not willing to apply highly effective contraception during the study and through the duration as defined below after the final dose of study treatment
a. Women of childbearing potential defined as all women physiologically capable of becoming pregnant. Must use highly effective contraception during the study and through 20 months after the final dose of study treatment. Highly effective contraception is defined as either:
1. Total abstinence: When this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
2. Sterilization: Patient has had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman had been confirmed by follow- up hormone level assessment
3. Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female study patients, the vasectomized male partner should be the sole partner for that patient
4. Use a combination of the following (both a + b):
1. Placement of a non-hormonal intrauterine device (IUD) or non- hormonal intrauterine system (IUS)
2. Barrier method of contraception: Condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
Note: Hormonal contraception methods (e.g. oral, injected, implanted) are not allowed as it cannot be ruled out that the study drug decreases the effectiveness of hormonal contraception.
Note: Women are considered post-menopausal and not child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels \>40 mIU/mL and estradiol \<20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six week ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
* History of hypersensitivity to paclitaxel
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Patients who are receiving treatment with medications known to be moderate and strong inhibitors or inducers of CYP3A4/5 or drugs metabolized by CYP2B6 or CYP2C9 that have narrow therapeutic index, and that cannot be discontinued before starting treatment with sonidegib. Medications that are strong CYP3A4/5 inhibitors should be discontinued at least 7 days and strong CYP3A/5 inducers for at least 2 weeks prior to starting treatment with sonidegib | 20,100 |
Study Objectives
This clinical trial investigates if certain electronic games may be effective in improving attention and memory function in cancer survivors. Cancer related cognitive impairment (CRCI) is an issue experienced by many cancer patients/survivors. CRCI includes perceived or objective problems with memory, executive function, and attention/concentration. CRCI has a negative impact on survivors' ability to work, carry out routine activities, and engage in social and family relationships. CRCI may result in significant distress and reduced quality of life. Certain electronic games may help improve attention and memory function in cancer survivors and reduce symptoms of CRCI.
Conditions: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Intervention / Treatment:
BEHAVIORAL: Endeavor: Computer-Based Cognitive Stimulation Intervention, BEHAVIORAL: Words!: Computer-Based Cognitive Stimulation Intervention, OTHER: Quality of Life (QOL) Questionnaires
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Attention Function Index (AFI) score of \< 7.5
* Are able to read, write, and understand English
* Ability to understand an electronic informed consent document, and the willingness to sign it
* Have a Karnofsky performance status (KPS) score of \>= 50
* Have access to WiFi connection
Exclusion Criteria:
* Receiving active treatment for cancer recurrence
* Have significant cognitive impairment
* Have sensory or motor deficits that prevent them from doing the assessment and using the application | 3,605 |
Study Objectives
The purpose of this research study is to demonstrate that Deep Inspiration Breath Hold (DIBH), the technique used at the University of North Carolina (UNC) for left-side breast cancer radiation therapy, can reduce side effects to the heart.
Conditions: Breast Cancer
Intervention / Treatment:
OTHER: Cardiac SPECT perfusion scan
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* signed an Institutional Review Board (IRB)-approved informed consent document for protocol
* age \>= 18 years
* histologically confirmed left-sided breast cancer scheduled to undergo curative intent radiation treatment post lumpectomy or mastectomy
* stage 0-III left-sided breast cancer (including DCIS)
* SPECT score of 0 at baseline
* radiation oncologist agrees target volume coverage will not be compromised via use of the DIBH technique along with conformal field shaping
Exclusion Criteria:
* active cardiac disease, defined as a history of angina, arrhythmias, myocardial infarction, congestive heart failure, or any other cardiac condition, which in the opinion of the treating physician would make this protocol unreasonably hazardous for the patient
* symptomatic pulmonary disease currently requiring regular medication including but not restricted to bronchodilators
* concurrent chemotherapy
* prior receipt of mediastinal radiation therapy
* pregnant or lactating women
* inability to understand and follow breathing instructions for the DIBH procedure | 14,573 |
Study Objectives
The purpose of this study is to determine the safety and anti-tumor effects of an experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune cells which are designed to elicit the same anti-tumor mechanism that occurs in allogeneic bone marrow/stem cell mini-transplant (BMT) procedures, without the toxicity associated with graft vs. host disease (GVHD).
Conditions: Hematological Malignancy, Leukemia, Lymphoma, Multiple Myeloma
Intervention / Treatment:
BIOLOGICAL: AlloStim, BIOLOGICAL: AlloStim, BIOLOGICAL: AlloStim, BIOLOGICAL: AlloStim
Location: Israel
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* histologically confirmed hematological malignancy
* unresponsive to chemotherapy and/or recurrence after autologous transplant
* adequate kidney, liver, lung and heart function
Exclusion Criteria:
* prior allogeneic transplant
* immunosuppressive therapy for concurrent medical condition
* active viral infection | 34,255 |
Study Objectives
The purpose of this study is to test whether the use of advanced radiation therapy delivery techniques can spare a patient's normal tissue, including salivary glands, from radiation. This study is being done to try to reduce radiation side effects, especially mouth dryness, which happens with standard radiation methods. In order to reduce these side effects, other normal tissues may receive a different radiation dose (sometimes more) than what would have been received using standard radiation therapy. A secondary goal of this study is to determine if the type of tumor a patient has can be controlled at least as well (or better) using this advanced radiation therapy delivery technique as it would be if the patient was treated with standard radiation therapy.
Conditions: Head and Neck Cancer
Intervention / Treatment:
RADIATION: IMRT, DRUG: Paclitaxel, DRUG: Carboplatin, DRUG: Cisplatin, DRUG: 5-Fluorouracil
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* All patients must have histologically confirmed invasive cancer of the head and neck.
* Irradiation to both neck sides is required.
* Standard radiation techniques would irradiate most of both parotid glands to a high dose (\>50 Gy). Patients with oropharyngeal, oral, nasopharyngeal, hypopharyngeal and advanced laryngeal cancer are expected to fulfill this requirement.
* Patients with resectable disease that is either measurable, evaluable or non-measurable disease (post-operative) will be eligible.
* Karnofsky performance status \>60
* Patients receiving or not receiving chemotherapy are eligible.
* All patients must sign an informed consent.
* Pre-treatment laboratory criteria:
* WBC (White Blood Cell) \> 3500/ul, granulocyte \> 1500/ul.
* Platelet count \> 100,000/ul.
* Creatinine clearance \> 60 cc/min. to receive cisplatin; creatinine clearance 30-59 cc/min to receive carboplatin.
* Bilirubin \< 1.5 mg% with no evidence of obstructive liver disease.
* AST (Aspartate Aminotransferase) and ALT (Alanine Aminotransferase) equal to or less than 2.5 x upper limit of normal.
Exclusion Criteria:
* Patients who received past irradiation to the head and neck are not eligible.
* Prior head and neck malignancy or history of other prior non-head and neck malignancy within the past 3 years.
* Prior head and neck radiation or prior chemotherapy.
* Documented evidence of distant metastases.
* Active infection.
* Pregnancy or lactation; patients must use effective contraception during the course of the clinical trial.
* Any medical or psychiatric illness which in the opinion of the principal investigator would compromise the patients ability to tolerate this treatment.
* Patients residing in prison.
* Age \< 18 years. | 37,273 |
Study Objectives
A multi-center, randomized, double-blind, parallel controlled Phase III clinical study to evaluate the clinical efficacy and safety of MW032 and Xgeva® in patients with bone metastases from solid tumors.
Conditions: Bone Metastases
Intervention / Treatment:
DRUG: MW032, DRUG: Xgeva
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
1. Pathological confirmed malignant tumors (except hematological tumors);
2. Bone metastasis diagnosed by imaging (bone X-ray, CT scanning or magnetic resonance scanning) or pathology (bone biopsy) can be examined within 3 months before signing the informed consent,according to 《The expert consensus on clinical diagnosis and treatment of bone metastases and bone related diseases of malignant tumors (2014)》；
3. No limited of gender,age ≥ 18 years old;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2;
5. Estimated survival time was more than 6 months;
6. Subjects must have adequate organ function at baseline as defined below:① hematology: neutrophils ≥ 1,500/mcL, platelets ≥ 75,000/mcL, hemoglobin ≥ 80 g / L; ② renal function: creatinine (CR) clearance rate ≥ 30 ml / min; ③ Liver function: serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) were less than or equal to 2.0 × upper normal limit (ULN) in subjects without liver metastasis; ALT and AST were less than or equal to 5.0 × ULN in subjects with liver metastasis; serum total bilirubin was less than or equal to 1.5 × ULN; ④ serum calcium (albumin correction) was more than or equal to 2.0 mmol / L (8.0 mg / dl) but less than or equal to 2.9 mmol / L (11.5 mg / dl). Note: calcium supplements should not be used at least 8 hours before serum calcium determination in screening period;
7. Subjects has understood the nature and purpose of the study, as well as the research procedure, and the subject has signed the written informed consent;
Exclusion Criteria:
1. Subjects with diseases not suitable for the study,in the Investigator's opinion (according to the subject's report or medical record review), such as:Other malignant tumors (different from the malignant solid tumors required in this study protocol) occurred within 3 years before enrollment, and in the active period;Other diseases affecting bone metabolism, such as vitamin D deficiency rickets, osteomalacia and primary osteoporosis, hyperparathyroidism, osteitis deformans, etc. (excluding osteoporosis);Human immunodeficiency virus or Treponema pallidum infection;Unstable liver disease, active period of hepatitis B virus or hepatitis C virus infection;Other serious or unstable physical or mental disorders.
2. Brain metastasis.
3. Oral and dental diseases: previous or current evidence of osteomyelitis or necrosis of the jaw; acute dental or mandibular diseases, need to be treated oral surgery; planned invasive dental surgery; failed dental or oral surgery.
4. Subjects with bone metastases need radiotherapy or surgery.
5. Previous treatment with denosumab.
6. Patients who had received any kind of intravenous or oral bisphosphonates before administration of the first study drug. | 35,731 |
Study Objectives
This study is designed to characterize the effects of high energy radiation on bone breakdown, with a specific interest in reducing the rate of sacral fractures. Although radiation is very important in managing tumors, it is related to complications such as bone fractures. In this research study, the investigators are looking to determine changes in blood markers, bone density, and bone structure following radiation and to better understand the reason for these changes.
Conditions: Malignant Bone Tumors
Intervention / Treatment:
RADIATION: Radiation (Surgical Arm), RADIATION: Radiation (Non-surgical Arm), PROCEDURE: Malignant Tumor Surgery
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* All laboratory tests that are a part of the eligibility criteria must be completed within 14 days prior to the date of registration. Diagnostic tests that are a part of the eligibility criteria must be performed within 30 days of the date of registration. Participants must meet the following criteria on screening examination to be eligible to participate in the study:
* Study participants must have histologically confirmed primary malignant bone tumor in the sacrum for which surgery and radiation or radiation alone are planned.
* Age 18 years or older. In children under the age of 8, tetracycline derivatives have been reported to stain tooth enamel yellow color. These considerations lead us to exclude young persons under the age of 18 from the study.
* Participants must have normal organ and marrow function as defined below:
* Total bilirubin within normal institutional limits
* Aspartaataminotransferase (AST) (SGOT)/ Alanine-aminotransferase (ALT) (SGPT) \< 2.5 X institutional upper limit of normal
* Creatinine within normal institutional limits or creatinine clearance \> 60 mL/min/1.73 m2 for subjects with creatinine levels about institutional normal limit
* The effects of tetracyclines and radiation used in computer tomography on the developing human fetus are known to be detrimental. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
* Participants must be able to read and understand English language and have the ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
Participants who exhibit any of the following conditions at screening will not be eligible for admission into the study.
* Participants who have had surgery, chemotherapy, or radiotherapy of the sacrum prior to entering the study
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to tetracyclines.
* Pregnant or nursing
* Uncontrolled inter current illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements | 14,598 |
Study Objectives
The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).
Conditions: Preneoplastic Conditions, Prostatic Intraepithelial Neoplasia
Intervention / Treatment:
DRUG: Toremifene 20 mg, DRUG: Placebo
Location: Argentina, United States, Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE | Inclusion Criteria:
* Give voluntary signed informed consent in accordance with institutional policies
* Be male, aged ≥ 30 years
* Have a diagnosis of high grade PIN from any previous prostate biopsy. The diagnosis of high grade PIN must be confirmed by the central pathologist
* Have had a prostate biopsy in the last 6 months with a minimum of 10 cores that shows no evidence of cancer as confirmed by the central pathologist; OR, have had 2 prostate biopsies (each with a minimum of 6 cores) in the 12 months prior to screening with at least one of the biopsies occurring within 6 months prior to the screening visit. Both biopsies should have no evidence of cancer as confirmed by the central pathologist
* Have a serum PSA of ≤ 10 ng/mL
* Agree to provide tablet containers for tablet counts and to complete a daily diary of study drug intake
* Agree to use an effective method of contraception, if the partner is of child-bearing age, while on study and for 30 days after the last dose of study medication
* Have adequate bone marrow, liver and renal function:
* White Blood Cell (WBC) Count ≥ 3,000/mm3;
* Platelet Count ≥ 100,000/mm3;
* Bilirubin ≤ 1.5 mg/dL;
* AST and ALT \< 2x upper limit of normal;
* Serum Creatinine ≤ 2.0 mg%
Exclusion Criteria:
* Previous exposure to toremifene citrate
* Have evidence of prostate cancer (local, regional and/or distal metastasis)
* Have any history of other malignancies (Exceptions include non-melanoma skin cancer or other cancer that has no evidence of tumor reoccurrence 5 years after definitive treatment).
* Have active systemic viral, bacterial, or fungal infections requiring treatment
* Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
* Concurrently being treated with other investigational agents or have participated in an investigational study within 60 days prior to screening
* Currently taking dutasteride. Subject is eligible if he stops dutasteride for a total washout of 90 days prior to the Screening Visit and agrees not to use dutasteride for the duration of the study.
* Have previously taken finasteride for greater than two years
* Currently taking finasteride. Subject is eligible if he stops finasteride for a total washout of 30 days prior to the Screening Visit and agrees not to use finasteride for the duration of the study.
* Currently taking testosterone or testosterone-like supplements, such as dehydroepiandrosterone (DHEA). Subject is eligible if he stops these agents for a total washout of 30 days prior to the Screening Visit and agrees not to use these agents for the duration of the study.
* Have a history of taking PC-SPES within the past two years.
* Currently taking herbal medicine or dietary supplements for prostate health, such as Saw Palmetto (also known as Serenoa Repens).
Subject is eligible if he stops these agents for a total washout of 30 days prior to taking the first dose of study drug and agrees not to use these agents for the duration of the study.
Lycopene, vitamin E and selenium are not prohibited and no washout is required. However, vitamin E intake should be limited to less than 400 i.u. per day.
* Have a history of thromboembolic event or disease including deep vein thrombosis, pulmonary embolus, or thrombotic stroke
* History of chronic hepatitis or cirrhosis | 20,718 |
Study Objectives
The goal of this clinical research study is to learn if the combination of Avastin (bevacizumab) and Tykerb (lapatinib) can help to control ependymoma in pediatric patients. The safety of this drug combination will also be studied.
Conditions: Brain Cancer, Pediatric Cancers
Intervention / Treatment:
DRUG: Bevacizumab, DRUG: Lapatinib
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Age: Patient must be \< or = 21 years of age.
2. Tumor: Patients must have recurrent or refractory intracranial ependymoma (including myxopapillary, clear cell, papillary, tanycytic, and anaplastic ependymoma) or subependymoma. Patients with primary diagnosis of intracranial ependymoma with spinal cord metastases or relapse are eligible. The diagnosis must be confirmed by the CERN enrolling site's pathologist on tissue from either the initial presentation or time of recurrence prior to registration. For central pathology review and trial biological studies, submission of a paraffin block with tumor measuring at least 1 cm x 1 cm in area is preferred, but 15 x 5micro m unstained sections on slides may be provided by the referring laboratory instead. Tissue must be submitted within 60 days after enrollment for central processing and analysis.
3. Patients must have measureable disease which is defined as at least one measurable lesion that can be accurately measured in 2 planes. Diffuse leptomeningeal involvement ("sugar coating") that does not allow measurement of at least one lesion in 2 planes will not be considered measurable disease.
4. Patients may have had any number of prior treatment regimens (including biologic) before or after radiotherapy. Patients may not have previously been treated with Bevacizumab or Lapatinib. Gliadel wafers must be approved by CERN PI (Project Leader, Co-Leader and Protocol PI).
5. Neurological Deficits: Patients with neurological deficits should have deficits that are stable or improving for a minimum of 1 week prior to registration.
6. Performance Score: Karnofsky Performance Scale (KPS for \> 16 years of age) or Lansky Performance Score (LPS for \< or = 16 years of age) \> or = 50 assessed within 2 weeks prior to registration.
7. Evidence of recovery from any prior chemotherapy. No myelosuppressive anticancer chemotherapy or biological therapy within 3 weeks (6 weeks if a nitrosourea or mitomycin C agent) prior to registration.
8. Prior/Concurrent Therapy: external beam radiation therapy (XRT): Patients must have had prior radiation therapy for treatment of their ependymoma. XRT must be \> or = 3 months prior to registration for craniospinal irradiation (\> or = 18 Gy); \> or = 4 weeks for local radiation to primary tumor; and \> or = 2 weeks prior to registration for focal irradiation to symptomatic metastatic sites.
9. Prior/Concurrent Therapy: Bone Marrow Transplant: \> or = 3 months prior to registration for autologous bone marrow/stem cell transplant.
10. Prior/Concurrent Therapy: Anti-convulsants: Patients with seizure disorder may be enrolled if well controlled. Patients receiving enzyme-inducing anticonvulsants are not eligible for this study. Patients must be off EIACD for at least 2 weeks prior to registration.
11. Prior/Concurrent Therapy: Corticosteroids: Patients who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to registration.
12. Prior/Concurrent Therapy: Growth Factors: Off all colony forming growth factor(s) \> or = 2 weeks prior to registration (G-CSF, GM-CSF, Erythropoietin).
13. Patients must not have received: cytochrome P450 3A4 (CYP3A4) inhibitors within seven (7) days prior to registration on protocol and for the duration of the study. However, amiodarone, another CYP3A4 inhibitor, should have been discontinued 6 months prior to registration and for the duration of the study.
14. Patient must not have received: CYP3A4 inducers within fourteen (14) days prior to registration and for the duration of the study.
15. Patient must not have received: Cimetidine within 48 hours prior and for the duration of the study.
16. The following laboratory values must be assessed within 7 days prior to registration and must be repeated if initial labs were done greater than (\>seven) (7) calendar days prior to the start of therapy. Organ Function: Must have adequate organ function and marrow function as defined by the following parameters: Bone Marrow: Absolute neutrophil count \>or =1000microliter, Platelets \> or = 100,000 microliter (transfusion independent), Hemoglobin \>or =8.0 g/dL. Renal: Serum creatinine \<or = 1.5 times upper limit of institutional for age or glomerular filtration rate (GFR)\>or = 70ml/min/1.73m2 Hepatic: Total bilirubin \< or = 1.5 times upper limit of normal for age: serum glutamate pyruvate transaminase (SGPT) (ALT)\<2.5x institutional upper limit of normal for age and albumin \> or = 2g/dL. No overt renal, hepatic, cardiac or pulmonary disease.
17. No overt renal, hepatic, cardiac or pulmonary disease.
18. Adequate cardiac function, assessed within 2 weeks prior to registration, defined as: shortening fraction of \> or = 27% by echocardiogram, or ejection fracture (LVEF) \> or = 50% by gated radionucleotide study.
19. Adequate pulmonary function, assessed within 2 weeks prior to registration, defined as: no evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination.
20. Signed informed consent according to institutional guidelines must be obtained.
21. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately and will be removed from the study.
22. Patient must begin therapy within 7 calendar days of registration.
Exclusion Criteria:
1. Patients may not have previously been treated with Bevacizumab or Lapatinib.
2. Patients with any significant medical illnesses that, in the investigator's opinion, cannot be adequately controlled with appropriate therapy or would compromise the patient's ability to tolerate this therapy.
3. Patients with any disease that would obscure toxicity or dangerously alter drug metabolism.
4. Patients receiving any other anticancer or experimental drug therapy.
5. Patients with uncontrolled infection.
6. Patients on enzyme inducing anticonvulsants.
7. Patients with \> / = Grade 2 uncontrolled hypertension.
8. History of a stroke, myocardial infarction, or unstable angina in the previous 6 months.
9. Evidence of a bleeding diathesis, coagulopathy or PT international normalized ratio (INR)\>1.5.
10. Patients who require the use of therapeutic anti-coagulation: except as required to maintain patency of preexisting permanent vascular catheter.
11. Pre-existing coagulopathy or thrombosis: Patients must not have been previously diagnosed with a deep venous or arterial thrombosis (including pulmonary embolism), and must not have a known thrombophilic condition.
12. Patients must have recovered from any surgical procedure before enrolling on this study.
13. History of an abdominal fistula, GI perforation, or intra-abdominal abscess within previous 6 months.
14. A serious, non healing wound, ulcer, or bone fracture.
15. Evidence of a new intracranial or intratumoral hemorrhage that is larger than a punctuate size on baseline MRI obtained within 14 days prior to study registration.
16. If there is proteinuria present on dipstick, patients must have a 24 hour urine collection. Patients are excluded if they have \>500 mg protein on 24 hour urine collection.
17. Pregnancy: Females of childbearing potential must have negative serum or urine pregnancy test within 7 days prior to study entry. The effects of lapatinib on the developing human fetus are unknown. However, bevacizumab is known to be teratogenic and detrimental to fetal development and endometrial proliferation, thereby having a negative effect on fertility.
18. Breastfeeding: Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with lapatinib of bevacizumab, breastfeeding should be discontinued if the mother is treated on this study. | 35,831 |
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