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Study Objectives
Objective: to determine nerve mobilization techniques effectiveness at improving shoulder disability in the early breast cancer postsurgical period, and whether the effect was maintained at 24-month follow up. Design: prospective randomized and single blind trial where participants will be randomly allocated into two groups by EPIDAT 3.1 software. Follow-up will be conducted through seven physical therapy assessments: one before surgery, the second one after surgery, the third one post-physical therapy intervention, the fourth one after three months, the fifth after six months and, the sixth one after twelve months, and the seven one after 24 months. Participants: one hundred and forty women, who are undergoing a unilateral breast cancer surgery with axillary lymph node dissection in the Breast Cancer Unit from "Príncipe de Asturias" Hospital. Intervention: Early physical therapy to control group and Early physical therapy plus nerve mobilization to intervention group during the three following weeks from surgery. Hypothesis: nerve mobilization helps brachial plexus sliding among its interface which improves shoulder disability the inner arm.
Key outcomes: pain, functional impairment, physical therapy, quality of life. Data analysis: quantitative variables through t-student test and qualitative variable though Chi test through by Statistical Package for the Social Sciences software.
Conditions: Breast Cancer Female
Intervention / Treatment:
OTHER: Neural mobilization group, OTHER: Control group
Location: Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: TRIPLE | Inclusion Criteria:
* Women treated for unilateral breast cancer with surgery, including axillary lymph node dissection at the Department of Gynecology and Obstetrics of "Príncipe de Asturias" Hospital
* No contraindication to physical therapy
* Informed consent read, understood, and freely signed
Exclusion Criteria:
* Bilateral breast cancer
* Systemic disease (metastases)
* Infection
* Loco regional recurrence
* Chemotherapy as a neoadjuvant treatment | 38,910 |
Study Objectives
This clinical trial compares fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET)/computed tomography (CT) to the standard of care fluorodeoxyglucose F-18 (18F-FDG) PET/CT in imaging patients with newly diagnosed lung cancer or indeterminate pulmonary nodules. PET/CT uses a radioactive glutamate (one of the common building blocks of protein) called 18F-FSPG which may be able to recognize differences between tumor and healthy tissue. Since tumor cells are growing, they need to make protein, and other building blocks, for cell growth that are made from glutamate and other molecules. PET/CT using a radioactive glutamate may be a more effective method of diagnosing lung cancer than the standard PET/CT using a radioactive glucose (sugar), such as 18F-FDG.
Conditions: Lung Carcinoma, Solitary Pulmonary Nodule, Cigarette Smoking Behavior
Intervention / Treatment:
PROCEDURE: Computed Tomography, PROCEDURE: Computed Tomography, RADIATION: fluorodeoxyglucose F-18, DRUG: Fluorine F 18 L-glutamate Derivative BAY94-9392, OTHER: Laboratory Biomarker Analysis, PROCEDURE: Positron Emission Tomography, PROCEDURE: Positron Emission Tomography (PET)
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
- Have an indeterminate untreated pulmonary nodule (IPN) (7-30 mm diameter) on CT, or an indeterminate lung mass (\> 30 mm diameter), without prior examinations that establish that the lesion has been stable for two or more years, untreated.
or
* Have a newly diagnosed, untreated primary lung cancer diameter 7 mm or more.
* Be able to give informed consent, which will include a layman's explanation of the estimated amount of additional radiation that the patient will receive from the investigational PET/CT scan using 18F-FSPG
* Must agree at the time of study entry to undergo clinically indicated biopsy(ies) or a 24-month period of follow-up, as needed, to resolve the etiology of their IPN(s) or lung mass(es).
Exclusion Criteria:
* Pregnant or lactating patients will be excluded, as will females of childbearing potential who refuse to undergo a serum or urinary beta-HCG pregnancy test the day of either the 18F-FSPG or the 18F-FDG PET/CT scans, in accordance with the standard policy of the Medical Imaging Service at our facility. Women who have experienced 24 consecutive months of amenorrhea, have reached at least 60 years of age, or have had a tubal ligation or hysterectomy documented in their medical records are considered not to be of childbearing potential for the purposes of this protocol
* Patients with a body weight of 400 pounds or more or a body habitus or disability that will not permit the imaging protocol to be performed
* A recognized active lung infection
* Previous systemic or radiation treatment for cancer of any type within 1 year
* For patients who do not have a tissue diagnosis:
* Non-oncologic severe co-morbidities suggesting a life span of less than two years if not treated, as determined by the potential subject's treating physician. | 10,337 |
Study Objectives
The purpose of this study is to determine the safety and effectiveness of a combination of chemotherapy and radiotherapy in breast cancer patients after breast surgery.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Carboplatin, RADIATION: 3D-RT or IMRT
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:
* Age older than 18
* Pre- or post-menopausal women with Stage I and II breast cancer, triple negative tumors
* Biopsy-proven invasive breast cancer, excised with negative margins of at least 1 mm
* Status post segmental mastectomy, after sentinel node biopsy and/or axillary node dissection (Tumors \< 5 mm in size do not require nodal assessment) or after mastectomy
* No previous chemotherapy
* Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document
Exclusion Criteria:
* Previous radiation therapy to the ipsilateral breast
* Active connective tissue disorders, such as lupus or scleroderma
* Pregnant or lactating women | 39,128 |
Study Objectives
This is a multicenter, open-label extension study. Subjects who have received rhuMAb VEGF (Avastin) therapy in any Genentech-sponsored Phase I or Phase II cancer study and who did not show evidence of disease progression at completion of the parent study will be eligible for inclusion in this trial.
Conditions: Cancer
Intervention / Treatment:
DRUG: Avastin (bevacizumab)
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: NONE | Inclusion Criteria:
* Previous participation in and completion of a Genentech-sponsored rhuMAb VEGF Phase I or Phase II cancer study
* No evidence of progressive disease at completion of the parent study
* For women of childbearing potential, use of an effective means of contraception
* Signed informed consent
Exclusion Criteria:
* Any unresolved or irreversible rhuMAb VEGF-related ongoing serious adverse events occurring during the parent study
* Any history of central nervous system disease (e.g., primary brain tumor or seizures within 12 months of the first infusion on this study), and/or any evidence of brain metastases
* Compromised renal or hepatic function, as defined in the parent protocol
* Anemia, neutropenia, or thrombocytopenia, as defined in the parent protocol
* Pregnancy (positive pregnancy test) or lactation
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored rhuMAb VEGF cancer study
* Recent (within 3 weeks of the first infusion of this study) major surgical procedure, biopsy of a parenchymal organ, or significant traumatic injury
* Clinically significant cardiovascular disease (e.g., uncontrolled hypertension \[blood pressure of \>160/110 mmHg on medication\], myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac dysrhythmia requiring medication, or peripheral vascular disease (Grade II or greater)
* Serious, nonhealing wound, ulcer, or bone fracture
* Current or recent (within 10 days of the first infusion on this study) use of oral or parenteral anticoagulants or aspirin (except as required to maintain patency of permanent indwelling intravenous \[IV\] catheters)
* Inability to comply with study and/or follow-up procedures
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications | 1,092 |
Study Objectives
Background:
* Research suggests that breast cancers may arise from a population of stem cells in the normal mammary gland that produce clones of cancer cells.
* Researchers are now trying to determine what events may initiate the formation of cancer cells.
Objectives:
* To look for and describe breast stem cells from normal breast tissue from women who do not have breast cancer.
* To compare the breast stem cells between women at increased risk for breast cancer and women at average risk for breast cancer.
* To show a relationship between the number and type of breast stem cells with the density (appearance) of the mammogram (breast x-ray).
* To make cell cultures (grow cells under controlled conditions) from the breast stem cells.
Eligibility:
-Women 18 years of age and older who are at average or increased risk for breast cancer.
Design:
Participants complete a health history questionnaire, family history questionnaire and risk assessment questionnaire.
* Participants have a mammogram and breast biopsy (surgical removal of a sample of breast tissue).
* Women who can become pregnant have a urine pregnancy test....
Conditions: Breast Cancer
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | * INCLUSION CRITERIA:
Women age 18 and older.
No abnormal findings in the breast by physical examination.
Average Risk: must meet all criteria below.
* Gail model index of less than 1.7% over next 5 years.
* Claus model lifetime risk less than 10%.
* BRCAPro and Couch model less than 10% of being a BRCA mutation carrier OR tested negative for documented deleterious BRCA1/2 mutation in family.
Increased risk for invasive breast cancer by one of the following:
* Gail Model risk of greater than 1.7% over 5 years from study entry.
* Claus model lifetime risk to age 79 greater than or equal to 10%.
* History of high risk pathologic lesion: lobular carcinoma in situ, atypical hyperplasia, DCIS (ductal carcinoma in situ).
* Deleterious mutations in BRCA1/2, PTEN or P53.
* Greater than or equal to 10% chance of carrying BRCA1/2 gene mutation as assessed by BRCAPro and Couch model (22, 23). If a woman has a 20% risk of carrying a BRCA1/2 mutation by either model, she will meet eligibility criteria.
* History of unilateral breast cancer either invasive or in situ, and a normal contralateral breast by physical examination.
Willing to stop NSAIDS for 3 days prior to biopsy and aspirin 7 days prior to biopsy.
If history of cancer (other than squamous or basal cell skin cancers), subject must have no evidence of disease at time of enrollment AND no history of cancer directed treatment in the 3 months preceding enrollment.
Identification of dense area of breast tissue suitable for biopsy identified on mammogram by the radiologist.
EXCLUSION CRITERIA:
Current use of hormonal therapies (e.g. tamoxifen, aromatase inhibitors, hormone replacement therapy, oral contraceptive pills, topical or vaginal hormone medications are allowed.)
Chemotherapy and radiation within 3 months prior to breast biopsy procedure.
Breastfeeding within 3 months.
Pregnancy (determined by urine dipstick).
A suspicious unbiopsied lesion by physical examination or mammography of the breast(s) which is being studied.
Bleeding disorder.
Warfarin, low molecular weight heparin, or heparin use.
History of bilateral breast radiation. | 38,039 |
Study Objectives
This randomized clinical trial studies narrative or fact-based videos in increasing colorectal cancer screenings in African American communities. Informational videotapes may help increase the number of participants who engage in colonoscopy screenings. It is not yet known whether narrative videos may be more effective than fact-based videos in increasing colorectal cancer screenings.
Conditions: Colorectal Cancer, Healthy, no Evidence of Disease
Intervention / Treatment:
BEHAVIORAL: behavioral intervention, BEHAVIORAL: behavioral intervention
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Participants in each component (focus groups, surveys and educational programs) will be 18 years of age and over; these men and women are generally healthy, ambulatory and able to participate in events in their community; no women, men, or children of any ethnic or social background will be excluded from the educational program
* EDUCATIONAL INTERVENTION:
* Currently non-adherent to colorectal cancer screening
* Self-identify as African American
* Are 50 years of age or older
* Have the ability to provide informed consent in English
* FOLLOW-UP ASSESSMENTS:
* Must be non-adherent for CRC screening at the time of the educational program
* Have telephone service (mobile or landline), to participate in the follow up interviews
* Agree to providing consent for release/review of their medical record
Exclusion Criteria:
* Non-English speaking | 38,645 |
Study Objectives
RATIONALE: Drugs used in chemotherapy such as gemcitabine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with irinotecan works in treating patients with cancer of unknown primary origin.
Conditions: Carcinoma of Unknown Primary
Intervention / Treatment:
DRUG: gemcitabine hydrochloride, DRUG: irinotecan hydrochloride
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically confirmed carcinoma of undetermined origin, with any of the following light microscopic diagnoses:
* Adenocarcinoma
* Poorly differentiated non-small cell carcinoma
* Poorly differentiated squamous cell carcinoma
* Primary site not revealed by the following diagnostic tests:
* Complete history and physical
* Complete blood count and chemistries
* Chest x-ray and/or CT scan
* Abdominal CT scan
* Directed evaluation of symptomatic areas
* Mammogram in women
* Colonoscopy in patients with liver metastases to exclude a colon primary
* Hematoxylin and eosin (H\&E) staining OR immunostaining if H\&E results are unclear, including all of the following:
* Keratin or epithelial membrane antigen
* S-100 or HMB45
* LCA (CD45)
* Chromogranin or synaptophysin
* Thyroid transcription factor 1
* Measurable disease
* Patients with any of the following conditions are not eligible:
* Neuroendocrine tumors
* Women with axillary node involvement only
* Women with adenocarcinoma of the peritoneum
* Carcinoma involving only 1 site, with resectable tumor at that site
* Squamous cell carcinoma limited to cervical, supraclavicular, or inguinal lymph nodes
* Men with poorly differentiated mediastinal or retroperitoneal tumor with stains suggestive of germ cell origin or serum tumor markers (AFP/HCG)
* Men with prominent blastic bony metastases or markedly elevated prostate-specific antigen, suggesting prostate origin
* Must be willing to provide blood and tissue samples
* No brain or meningeal involvement
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* At least 12 weeks
Hematopoietic
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin must meet 1 of the following criteria:
* Less than or equal to upper limit of normal (ULN) and no UGT1A1 genotyping is required
* Greater than ULN but less than 2 times ULN and UGT1A1 for 6/7 genotype or 7/7 genotype patients
* Alkaline phosphatase no greater than 3 times ULN
* AST no greater than 3 times ULN (5 times ULN if liver metastases are present)
Renal
* Creatinine no greater than 2.0 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 5 years
* No other severe concurrent disease that would make the patient inappropriate for the study in the judgment of the investigator
* No uncontrolled infection
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No concurrent biologic agents
* No concurrent filgrastim (G-CSF)
Chemotherapy
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to more than 25% of the bone marrow
* No concurrent radiotherapy
Surgery
* More than 4 weeks since prior major surgery | 5,646 |
Study Objectives
This is a randomized, multi-center, single dose, open-label and Neulasta controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with Stage I - III invasive breast cancer receiving chemotherapy treatment.
Conditions: Breast Cancer, Neutropenia
Intervention / Treatment:
DRUG: F-627, DRUG: Neulasta
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
1. Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
2. Females ≥18 years of age.
3. Diagnosed with Stage I-III breast cancer.
4. Subject is scheduled to undergo 4 cycles of neoadjuvant or adjuvant TC chemotherapy (docetaxel, cyclophosphamide, 75, 600 mg/m2, respectively).
5. ECOG Performance status of ≤2.
6. WBC count ≥4.0 × 109/L, hemoglobin ≥11.5 g/dL and a platelet count ≥150 × 109/L.
7. Demonstrate adequate renal, hepatic, and cardiac function (liver function tests \[alanine aminotransferase {ALT}, aspartate aminotransferase {AST}, alkaline phosphatase, and total bilirubin\]) should be less than 2.5x the upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
8. All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.
Exclusion Criteria:
1. Subject is \<18 years of age.
2. Disease progression has occurred while receiving a taxane regimen.
3. Subject has undergone radiation therapy within 4 weeks of enrollment.
4. Subject has undergone bone marrow or stem-cell transplantation.
5. Subject has a history of prior malignancy other than breast cancer that is NOT in remission.
6. Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e., lithium) within 6 weeks of the screening period are excluded.
7. Subject has had chemotherapy within 180 days of screening.
8. Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, electrocardiogram (ECG) test, or any other relevant test.
9. History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
10. Unwillingness to participate in the study.
11. Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
12. Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment (if known), which ever is less.
13. Any condition, which can cause splenomegaly.
14. Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
15. ALT, AST, alkaline phosphatase, total bilirubin ≥2.5x ULN.
16. Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
17. Women who are pregnant or breast-feeding.
18. Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
19. Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
20. Subjects with Sickle Cell disease
21. Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug. | 5,085 |
Study Objectives
RATIONALE: Placing the gene for interleukin-12 into breast cancer cells may help the body build an immune response to kill tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gene therapy in treating women with metastatic breast cancer.
Conditions: Breast Cancer
Intervention / Treatment:
BIOLOGICAL: adenovirus-mediated human interleukin-12
Location: 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 confirmed metastatic adenocarcinoma of the breast
* Malignant disease in the skin, chest wall, or other sites (lymph nodes or primary tumor in the breast) accessible to percutaneous needle placement and injection
* Solitary or multiple tumors
* Measurable disease in ≥ 2 dimensions by physical examination or CT/MRI scan
* Malignant tumors in the skin and chest wall must be ≥ 4 mm in diameter by physical examination
* Malignant tumors in other accessible sites must be ≥ 1 cm in diameter on physical examination
* Malignant disease in other organs (in addition to skin or chest wall metastases) allowed
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Karnofsky performance status 70-100%
* Life expectancy ≥ 16 weeks
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Hemoglobin ≥ 9.0 mg/dL
* PT normal
* Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
* Serum total bilirubin ≤ 2.0 times upper limit of normal (ULN)
* Serum transaminases ≤ 2.5 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Weight ≥ 30 kg (for patients treated with the highest dose level of study drug)
* No active infection or concurrent serious medical illness
* No HIV positivity
* No other malignancy within the past 5 years except for the following:
* Inactive nonmelanoma skin cancer
* In situ carcinoma of the cervix
* Grade 1 papillary bladder cancer
PRIOR CONCURRENT THERAPY:
* More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
* No anticoagulant therapy with heparin or warfarin for ≥ 2 months after completion of study treatment | 34,303 |
Study Objectives
RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced or metastatic solid tumors that have not responded to previous therapy.
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
BIOLOGICAL: salmonella VNP20009, DRUG: cefixime, DRUG: ceftriaxone sodium, DRUG: ciprofloxacin, DRUG: trimethoprim-sulfamethoxazole
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS: Histologically proven advanced or metastatic solid tumors that have failed prior therapy and no other therapy is available At least 1 tumor mass of a size that makes intratumoral injection feasible and biopsy or fine needle aspiration possible Major surgery for cancer not required No lymphoma No concurrent brain metastases (previously treated brain metastases with no evidence of recurrence allowed)
PATIENT CHARACTERISTICS: Age: 18 and over Menopausal status: Not specified Performance status: Karnofsky 70-100% OR ECOG 0-1 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hematocrit at least 30% (transfusion allowed) No bleeding disorder Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT/AST no greater than 1.5 times ULN (3 times ULN in the presence of liver metastases) Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN in the presence of liver metastases) PT and aPTT no greater than 1.5 times ULN No end stage liver disease Renal: Creatinine no greater than 1.5 times ULN No urinary tract stones No end stage renal disease Cardiovascular: No known valvular disease or ischemic peripheral vascular disease No clinically significant atherosclerotic disease or arterial aneurysm(s) No unstable angina No active coronary artery disease requiring medication No myocardial infarction within the past 6 months No congenital heart failure or cardiac arrhythmia requiring medication Pulmonary: No severe oxygen-dependent chronic obstructive pulmonary disease Other: HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Permanent central venous catheters and other indwelling devices allowed if easily removed or replaced No gallstones No active infection No Salmonella infection within the past 6 months No fever caused by tumor or unknown cause (daily temperature no greater than 38 degrees C) No immunodeficiency No other life-threatening illness No commercial food handler, day-care worker, or health-care worker who plans to continue employment during protocol treatment No allergy to quinolone or cephalosporin antibiotics
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 6 months since any prior bone marrow transplantation At least 4 weeks since prior biologic therapy and recovered No other concurrent biologic therapy No prior allogeneic transplants Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No concurrent chemotherapy Endocrine therapy: At least 2 weeks since prior hormonal therapy No concurrent steroids Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics At least 2 weeks since prior surgery and recovered No artificial implant (e.g., heart valves or prosthetic hips or knees) No prior splenectomy Other: No other concurrent antibiotics No concurrent immunosuppressives No concurrent medications that directly or indirectly suppress the immune system | 710 |
Study Objectives
Patients who have no response to preoperative chemotherapy and no residual disease following surgery on Regimen A are treated on Regimen B postoperatively.
The following acronyms are used:
DDD Mitotane, NSC-38721
DOX Doxorubicin, NSC-123127
VCR Vincristine, NSC-67574
VP-16 Etoposide, NSC-141540
Regimen A: 4-Drug Combination Chemotherapy followed by Surgery followed by 4-Drug Combination Chemotherapy. DDD/DOX/VCR/VP-16; followed by surgical debulking; followed by DDD/DOX/VCR/VP-16.
Regimen B: Single-Agent Chemotherapy. DDD.
Conditions: Adrenal Cortical Carcinoma
Intervention / Treatment:
DRUG: doxorubicin, vincristine, and etoposide with mitotane
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | Biopsy-proven primary or recurrent adrenocortical carcinoma considered surgically resectable at presentation or potentially resectable following an initial response to chemotherapy.
Potentially resectable disease includes primary lesion, nodal metastases, and liver and lung metastases if limited in size and number.
Patients for whom surgical resection is considered unlikely may be entered at the discretion of the investigator.
Measurable disease at presentation required.
A life expectancy of at least 3 months and a performance status (Karnofsky scale) of 70 percent or greater.
Prior chemotherapy is allowed, however, the patient should not have received chemotherapy four weeks before presentation.
Patients who have received prior doxorubicin may be enrolled provided they meet all other entry criteria and have an ejection fraction greater than 40 percent determined by MUGA scan.
Prior mitotane therapy is allowed. A dose of 3 gm/day should have been tolerated for at least one week. Patients do not need to be off mitotane therapy prior to starting this protocol.
WBC greater 3,000/mm(3); Platelet count greater than 100,000/mm(3); Creatinine clearance greater than 50 ml/min; bilirubin less than 1.5 mg/dl; serum transaminase less than 2 times normal.
Patient should be a good surgical candidate.
Must sign an informed consent and be geographically accessible to return for follow up treatment.
No presence of a second malignancy, other than squamous cell carcinoma of the skin.
No active systemic infection.
Must not be currently receiving treatment which cannot be discontinued with the following agents: diltiazem, nicardipine, phenothiazines, phenytoin, terfenadine or verapamil.
No positive serology for HIV.
No positive pregnancy test. | 1,972 |
Study Objectives
Based on success in other diseases, the Fred Hutchinson Cancer Research Center (FHCRC) has developed a transplant procedure for Fanconi anemia (FA), which does not completely destroy the patient's remaining bone marrow. It should also be less harmful (toxic). Researchers wish to test whether this approach can overcome the graft failure often seen when bone marrow or peripheral blood stem cells from an unrelated donor are used. Researchers also will look at whether the procedure is less toxic than a conventional bone marrow transplant (BMT).
Conditions: Adult Acute Myeloid Leukemia in Remission, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Childhood Acute Myeloid Leukemia in Remission, Childhood Myelodysplastic Syndromes, Fanconi Anemia, Previously Treated Myelodysplastic Syndromes
Intervention / Treatment:
DRUG: fludarabine phosphate, DRUG: cyclosporine, RADIATION: total-body irradiation, PROCEDURE: allogeneic bone marrow transplantation, PROCEDURE: allogeneic hematopoietic stem cell transplantation, PROCEDURE: peripheral blood stem cell transplantation, DRUG: mycophenolate mofetil
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 patient with marrow failure and increased chromosome fragility as determined in the diepoxybutane (DEB) or mitomycin C test
* Any patient with Fanconi anemia (FA) with marrow failure meeting the following criteria:
* Granulocyte count \< 0.2 x 10\^9/L
* Platelet count \< 20 x 10\^9/L
* Hemoglobin \< 8 g/dl
* Corrected reticulocyte count \<1%
* Any patient with FA as determined by DEB fragility, who has life-threatening marrow failure involving a single hematopoietic lineage
* Any patient with FA and pre-existing cytogenetic abnormality including hematopoietic malignancy (myelodysplastic syndromes \[MDS\] or acute myeloid leukemia \[AML\]) in remission
* DONOR: Unrelated Donors who are prospectively: Matched for human lymphocyte antigen (HLA)-DRB1 and DQB1 alleles (must be defined by high resolution typing); only a single allele disparity will be allowed for HLA -A, B, or C as defined by high resolution typing
* DONOR: HLA typing will be performed at the highest level of resolution available at the time of transplant
Exclusion Criteria:
* Evidence for hematopoietic malignancy in relapse
* Heart or lung disease that would prevent compliance with conditioning and GvHD regimen or would severely limit the probability of survival
* Human immunodeficiency virus (HIV) seropositive patients
* Females who are pregnant or breastfeeding, or unwilling to use contraceptive techniques during and for the 12 months following treatment
* DONOR: Donors who by DEB testing are found to have FA
* DONOR: Donors who test positive in the lymphocytotoxic crossmatch assay
* DONOR: Donors who are HIV positive
* DONOR: Donors who for other medical or psychological reasons are not suitable as donors | 16,530 |
Study Objectives
This is a phase 2 study (the second phase in testing a new drug or combination to see how effect the drug or combination is) of investigational drugs GSK2256098 and Trametinib.
The purpose of the study is to evaluate the antitumor activity of GSK2256098 and Trametinib in patients with advanced pancreatic cancer.
Conditions: Pancreatic Cancer, Adenocarcinoma
Intervention / Treatment:
DRUG: GSK2256098, DRUG: Trametinib
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Male or female, 18 years or older, able to give written consent
* Pancreatic adenocarcinoma that is not responsive to standard therapies or for which there is no approved or curative therapy or for patients who refuse standard therapy
* Have clinical, radiographic, or serologic progression after one prior line of chemotherapy for advanced disease. Patients who have received two or more prior lines of chemotherapy for advanced disease are not eligible.
* Performance Status score of 0 or 1
* Measureable disease by RECIST version 1.1
* Able to swallow and retain oral medication
* Have malignant disease that is amenable to biopsy and agree to collection of mandatory tumor biopsy samples.
* Agrees to use contraception
* Not pregnant
* Adequate organ system function
Exclusion Criteria:
* Chemotherapy, radiotherapy, immunotherapy, or other anti-cancer therapy including investigational drugs within 28 days or 5 half lives. No prior MEK inhibitor, RAF inhibitors or a FAK inhibitors
* Current use of a prohibited medication
* Unresolved toxicity greater than Grade 1 from previous anticancer therapy unless the ongoing toxicity will not introduce additional risk factors and will not interfere with the study procedures.
* Presence of active GI disease or other condition that could affect gastrointestinal absorption or predisposed to GI ulceration
* Evidence of mucosal or internal bleeding
* Anticoagulation with warfarin
* Major surgery within the last four weeks
* Malignancies related to HIV or HBV/HCV
* Known active infection requiring parenteral or oral anti-infective treatment
* Leptomeningeal disease.
* Brain metastases
* QTcF interval ≥ 480 msecs
* History or evidence of current clinically significant uncontrolled arrhythmias
* History of acute coronary syndromes, myocardial infarction, coronary angioplasty, or stenting or bypass grafting within six months of screening.
* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system.
* Other clinically significant ECG abnormalities
* Intra-cardiac defibrillators.
* Presence of cardiac metastases.
* Serious or unstable pre-existing medical, psychiatric, or other condition that could interfere with patient's safety or providing informed consent.
* Known immediate or delayed hypersensitivity to any of the components of the study treatment(s).
* Evidence of severe or uncontrolled systemic diseases
* Pregnant or lactating
* History of retinal vein occlusion
* History of interstitial lung disease or pneumonitis | 30,548 |
Study Objectives
In this study, the investigator's want to find out if dabrafenib can stop stage IIIC melanoma from coming back after surgery.
Conditions: Melanoma
Intervention / Treatment:
DRUG: Dabrafenib
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:
* AJCC (2009) stage IIIC cutaneous melanoma rendered free of disease by surgical resection no greater than 90 days prior study enrollment. Patients with unknown primaries will be eligible for this trial. Patients with a history of resected stage I or II cutaneous melanoma who subsequently have their first disease recurrence meeting the criteria for stage IIIC disease will also be eligible for this trial.
* Patients must have clear margins after wide local excision. Patients with nodes that are palpable or detectable on radiologic imaging must have an adequate lymphadenectomy.
* Patients must be adequately recovered from surgery, radiation therapy, or any surgical complications prior to enrollment. In general, this means patients will be off antibiotics from wound infections and drains removed. However, if necessary, patients can be treated with a drain in place at the discretion of the PI if the 90 days window is about to expire.
* Histologic proof of melanoma reviewed and confirmed by MSKCC.
* A documented BRAFV600E or BRAFV600K mutation by genotyping or IHC \[35\]performed by a CLIA certified laboratory.
* Age ≥ 16 years old
* ECOG performance status = 0 or Karnofsky Performance Status equivalent
* The ability to swallow pills.
* Patients must have adequate organ and marrow function as defined below:
Absolute neutrophil count ≥1.5 K/mcL Platelets ≥ 100 K/mcL Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN)
≤ 3.0 X institutional ULN if the patient has Gilbert's Syndrome AST (SGOT) and ALT (SGPT) ≤ 2.5 X institutional ULN Creatinine ≤ 1.5 X institutional ULN or creatinine clearance (calculated or measured) \> 60 ml/min
* Women with child bearing potential and men with reproductive potential must be willing to practice acceptable methods of contraception.
Exclusion Criteria:
* Patients with a history of stage III melanoma (any primary melanoma with locoregional nodal/subcutaneous disease) treated with surgical resection who subsequently have disease recurrence meeting the criteria for stage IIIC disease.
* Prior therapy with ipilimumab, other BRAF inhibitors, or MEK inhibitors.
* Concurrent adjuvant immunotherapy, chemotherapy, or radiotherapy.
* Current use of a prohibited medication while on dabrafenib
* Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs.
* A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency.
* Pregnant women and lactating women.
* A concurrent second malignancy even if it does not require active therapy. Patients with indolent B-cell malignancies will not be eligible. Prior malignancy will be allowed as long as the patient is known to be free of disease for at least 3 years.
* 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.
* QTc interval \> 500 msec unless a bundle branch block is also present. | 2,756 |
Study Objectives
The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer.
Conditions: Prostatic Cancer
Intervention / Treatment:
DRUG: Quinacrine
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients must be males, at least 18 years of age, with pathologically confirmed adenocarcinoma of the prostate
* Patients must have evidence of androgen-independent metastatic prostate cancer (AIMPC) following standard antiandrogen withdrawal. AIMPC will be defined as the category of patients with metastatic prostate cancer with radiologic evidence of metastases (bone scan, CT, etc.) and castrate levels of testosterone (\~ 50 ng/dL).
1. All patients must be receiving ongoing therapy to ensure testicular androgen suppression (LHRH agonists therapy or bilateral orchiectomy).
2. All patients receiving anti-androgen therapy \[e.g., flutamide (Eulexin), bicalutamide (Casodex), or nilutamide (Nilandron)\] must have initiated therapy at least 3 months (90 days) prior to the Baseline visit.
* Patients must have received prior docetaxel-based or mitoxantrone-based chemotherapy, or refused or been ineligible for chemotherapy. Previous chemotherapy treatments must be completed at least 4 week prior to Screening, and patients must not have any residual therapy-related toxicities present at Screening.
* Patients must have evidence of disease progression defined as any of the following:
1. New sites of metastatic disease on radiographic imaging (bone scan or CT scan of chest/abdomen/pelvis) as determined by the referring physician.
2. PSA progression, defined as a 50% or greater rise in PSA value over a baseline level of at least 1.0 ng/mL, confirmed after an interval of at least two weeks.
* ECOG performance status 0-2 (see Appendix 4)
* Patients must have adequate organ and bone marrow function as defined below:
1. Absolute neutrophil count greater than 1500/mL
2. Platelets greater than 100,000/mL
3. Serum creatinine less than 2.0 mg/dL
4. Total bilirubin less than 1.5 mg/dL
5. AST (SGOT) and ALT (SGPT) less than 2 times the ULN \[less than 5 times the ULN if liver metastases are present\].
* Sexually active men whose sexual partners are women of childbearing potential must agree to use a medically acceptable form of barrier contraception or abstinence during their participation in the study and for at least six weeks after study drug discontinuation.
* Written informed consent/HIPAA authorization must be provided prior to the performance of any study-related procedures.
Exclusion Criteria:
* Prior allergic reactions or a history of intolerance attributed to quinacrine or other acridine derivatives
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, hematological disorders, hepatic disease, or psychiatric illness/social situations that would limit compliance with study requirements.
* Lifetime history of porphyria or psoriasis
* Documented glucose-6-phosphate dehydrogenase deficiency
* Lifetime history of seizure disorder (except infant febrile seizures)
* Lifetime history of schizophrenia, bipolar disorder, or any other psychotic disorders.
* Lifetime history of dermatitis as an allergic/toxic reaction to any medication
* Clinical evidence of CNS metastases
* Patients with a history of any malignancy (other than basal, squamous cell cancers and Ta bladder cancers) within 5 years of baseline visit
* Any grade 2 sensory neuropathy
* QTc (Bazett) \>450 msec
* Patients with NYHA class 3 or 4 failure
* Patients with myocardial infarction or acute coronary syndrome within the previous 6 months
* Patients who require anti-arrhythmic treatment | 20,018 |
Study Objectives
This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause melanoma.
Conditions: Melanoma
Intervention / Treatment:
DRUG: epothilone b
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
The following patients may be eligible for this study:
* Patients with advanced metastatic melanoma defined as poor prognosis Stage III melanoma and Stage IV disease, which has been histologically or cytologically confirmed with at least one measurable lesion not including bone metastases (if previous radiation treatment, the target lesion must have demonstrated progression since the radiation)
* Patients with poor prognosis Stage III melanoma must have locally advanced unresectable disease that is measurable (repeat histological or cytological confirmation is not necessary at the time of study entry if previous results are available and there is no question in the investigator's opinion as to the diagnosis)
* Must have a life expectancy of greater than three (3) months
* Prior immunotherapy with interferon alpha in the adjuvant setting is permitted, but must have been completed \> 4 weeks prior to treatment
* Prior vaccine therapy is permitted, but must have been completed \> 4 weeks prior to treatment
* Patient has no major impairment of hematological function (red blood cell transfusions and repeat evaluations for study entry are allowed).
Exclusion Criteria
The following patients are not eligible for this study:
* Patients with choroidal ocular melanoma
* Patients with symptomatic CNS metastases or leptomeningeal involvement
* Patients with renal or hepatic dysfunction
* Patients with any peripheral neuropathy or unresolved diarrhea greater than Grade 1
* Patients with severe cardiac insufficiency
* Patients taking Coumadin or other warfarin-containing agents with the exception of low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports
* Patients who have received any investigational compound or anti-melanoma vaccine within the past 28 days or those who are planning to receive other investigational drugs while participating in the study
* Patients who had received radiotherapy within the last 4 weeks to a site which will be the reference for disease assessment (however, new or progressive lesions in the previously irradiated fields of these patients may be used for disease assessment and patients must have recovered from the side effects of radiotherapy)
* Patients receiving chemotherapy within the last four weeks
* History of another malignancy within 5 years prior to study entry except curatively treated non-melanoma skin cancer or cervical cancer in situ
* Patients with active or suspected acute or chronic uncontrolled infection including abcesses or fistulae
* HIV+ patients
* Pregnant or lactating females. | 7,309 |
Study Objectives
The primary objective of this pilot study is to evaluate the effect of the HPV vaccine Gardasil on anal condylomata recurrence and persistence rates in HIV positive patients.
Conditions: HIV Positive, Anal Condylomata, Anal Warts, HIV Infections
Intervention / Treatment:
DRUG: Saline, DRUG: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* ≥18 years of age;
* HIV positive status;
* CD4 \> 200 and viral RNA \< 400 on anti-retroviral therapy (HAART) or CD4 \> 350 if not on HARRT;
* the presence of anal warts that require surgical excision/ablation.
Exclusion Criteria:
* CD4 \< 200 and/or viral RNA \> 400 on HAART or CD4 \< 350 and not on HAART ;
* low burden of anal warts that would not require surgical excision/ablation;
* previous vaccinations against HPV or allergic reactions to any vaccine component;
* patients who are currently pregnant;
* patients with a previous diagnosis of anal cancer;
* patients who are incarcerated;
* patients who have taken immunomodulators (i.e. interferon, interleukin, corticosteroids, etc.) within the last 90 days;
* patients who have had an opportunistic infection in the last 90 days or who have another intercurrent illness that precludes their safe enrollment in this study;
* patients who, in the judgment of the investigators, are unlikely to adhere to the protocol, either because of a substance abuse or psychiatric diagnosis, or other factors that would affect compliance;
* failure to strictly comply with the vaccination schedule. | 19,138 |
Study Objectives
This randomized phase I trial studies how well anti-semaphorin 4D (anti-SEMA4D) monoclonal antibody VX15/2503 with or without ipilimumab or nivolumab work in treating patients with stage I-III pancreatic cancer that can be removed by surgery or stage IV colorectal cancer that has spread to the liver and can be removed by surgery. Monoclonal antibodies, such as anti-SEMA4D monoclonal antibody VX15/2503, ipilimumab, and nivolumab, may interfere with the ability of tumor cells to grow and spread.
Conditions: Colon Carcinoma Metastatic in the Liver, Colorectal Adenocarcinoma, Pancreatic Adenocarcinoma, Resectable Pancreatic Carcinoma, Stage I Pancreatic Cancer, Stage IA Pancreatic Cancer, Stage IB Pancreatic Cancer, Stage II Pancreatic Cancer, Stage IIA Pancreatic Cancer, Stage IIB Pancreatic Cancer, Stage III Pancreatic Cancer, Stage IV Colorectal Cancer, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer
Intervention / Treatment:
BIOLOGICAL: Anti-SEMA4D Monoclonal Antibody VX15/2503, BIOLOGICAL: Ipilimumab, BIOLOGICAL: Nivolumab, PROCEDURE: Surgery
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* For patients with pancreatic cancer:
* Stage I-III cytologically or histologically-proven pancreatic adenocarcinoma
* Cancer confirmed to be surgically resectable, with surgery evaluation with planned resection
* Patients may have prior neoadjuvant chemotherapy, but no neoadjuvant chemoradiation
* No cancer chemotherapy treatment 2 weeks prior to day 2 of treatment
* For patients with metastatic colorectal cancer:
* Stage IV histologically-proven colorectal adenocarcinoma
* Liver metastasis confirmed to be surgically resectable, with surgery evaluation and planned resection; may have minimal extrahepatic disease that is determined to be resectable
* Tumor must be confirmed to be microsatellite stable (MSS); if not already reported at a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, we will be able to perform this at Emory University
* No prior immunotherapy
* No cancer chemotherapy treatment 2 weeks prior to day 1 of treatment
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Absolute neutrophil count ≥ 1,500 cells/µL
* Platelets ≥ 100,000/µL
* Hemoglobin ≥ 9.0 g/dL (may receive packed red blood cell \[prbc\] transfusion)
* Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
* Albumin ≥ 3.0 g/dL
* Serum creatinine ≤ 1.5 x ULN
* Calculated creatinine clearance of ≥ 50 mL/min
* International normalized ratio (INR) ≤ 1.5; anticoagulation is allowed only with low molecular weight heparin (LMWH); patient receiving LMW heparin on stable therapeutic dose for more than 2 weeks or with factor Xa level \< 1.1 U/mL are allowed on the trial
* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* Ability to understand and willingness to sign a written informed consent document
* Female subjects of childbearing potential must agree to use adequate contraception (e.g., hormonal or barrier method of birth control; abstinence) for the duration of study treatment and 3 months after completion
* Male subjects must agree to use adequate contraception (e.g., condoms; abstinence) for the duration of study treatment and 3 months after completion
* Female subjects of childbearing age must have a negative serum pregnancy test at study entry
Exclusion Criteria:
* Poor venous access for study drug administration
* Determined not to be a surgical candidate due to medical co-morbidities
* Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
* Prior organ allograft or allogeneic bone marrow transplantation
* Subjects with any active autoimmune disease or history of known or suspected autoimmune disease except for subjects with vitiligo, resolved childhood asthma/atopy, type I diabetes mellitus, residual hypothyroidism, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll
* Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration; inhaled or topical steroids and adrenal replacement doses \> 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
* Women who are pregnant or lactating
* Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association \[NYHA\] class III or IV), unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
* Clinical evidence of bleeding diathesis or coagulopathy
* Patients with prior malignancies, including pelvic cancer, are eligible if they have been disease free for \> 5 years; patients with prior in situ carcinomas are eligible provided there was complete removal
* Active bacterial or fungal infections requiring systemic treatment within 7 days of treatment
* Use of other investigational drugs (drugs not marked for any indication) within 28 days or at least 5 half-lives (whichever is longer) before study drug administration
* History of severe hypersensitivity reactions to other monoclonal antibodies
* Non-oncology vaccines within 28 days prior to or after any dose of ipilimumab | 35,836 |
Study Objectives
RATIONALE: Drugs used in chemotherapy, such as bleomycin, etoposide, and cisplatin, 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. It is not yet known which schedule of bleomycin is more effective when given together with etoposide and cisplatin in treating metastatic germ cell cancer of the testicles.
PURPOSE: This randomized phase III trial is studying two different schedules of bleomycin to compare how well they work when given together with etoposide and cisplatin in treating patients with metastatic germ cell cancer of the testicles.
Conditions: Drug/Agent Toxicity by Tissue/Organ, Testicular Germ Cell Tumor
Intervention / Treatment:
BIOLOGICAL: bleomycin sulfate, DRUG: cisplatin, DRUG: etoposide, PROCEDURE: management of therapy complications
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Diagnosis of metastatic germ cell cancer of the testes
* Good-prognosis disease
* Eligible for treatment with bleomycin, etoposide, and cisplatin
PATIENT CHARACTERISTICS:
* Creatinine clearance ≥ 60 mL/min
* No other prior or concurrent malignancy except basal cell skin cancer
* No other major systemic illness
* No impaired respiratory function, including any of the following:
* Shortness of breath on minimal exertion
* Hypoxia at rest
* Carbon monoxide transfer, total lung capacity, and FEV_1 \> 60% of predicted
PRIOR CONCURRENT THERAPY:
* No prior chemotherapy or radiotherapy | 43,805 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.
Conditions: Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Intervention / Treatment:
DRUG: carboplatin, DRUG: gemcitabine hydrochloride, DRUG: paclitaxel
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma
* No tumors of low-malignant potential (borderline tumors)
* No symptomatic brain metastases
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2 OR
* Karnofsky 70-100%
Life expectancy:
* At least 6 months
Hematopoietic:
* WBC at least 3,000/mm\^3
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin greater than 10 g/dL
Hepatic:
* Bilirubin no greater than 2 times upper limit of normal
Renal:
* Glomerular filtration rate at least 60 mL/min
Cardiovascular:
* No history of congestive heart failure (New York Heart Association class III or IV heart disease) even if medically controlled
* No myocardial infarction within the past 6 months
* No history of atrial or ventricular arrhythmias
Neurologic:
* No history of seizure disorder
* No history of CNS disorder
* No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater
Other:
* No severe concurrent infection
* No prior hypersensitivity reaction to products containing Cremophor EL or compounds chemically related to carboplatin, paclitaxel, or gemcitabine
* No complete bowel obstruction
* No other concurrent severe medical problems that would preclude study
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
* No concurrent WBC transfusions
Chemotherapy:
* No prior chemotherapy
* No other concurrent chemotherapy
Endocrine therapy:
* No concurrent hormonal therapy except replacement therapy or steroid antiemetics
Radiotherapy:
* No prior radiotherapy
* No concurrent radiotherapy
Surgery:
* No more than 6 weeks since prior definitive surgery | 38,587 |
Study Objectives
Aim 1: To compare the overall toxicant exposure in pregnant women who use electronic cigarettes (e-cigs, vapor, e-liquid, e-juice, vape, vaping devices) compared to women who smoke conventional cigarettes.
Aim 2. To compare toxicant exposure and birth outcomes among infants born to pregnant women who use e-cigs compared to women who smoke conventional cigarettes.
Aim 3. To explore potential mechanisms by which e-cigs could influence birth weight.
Conditions: Cigarette Smoking-Related Carcinoma
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. cigarette smokers who exclusively smoke conventional cigarettes daily, or who use e-cigs daily, or who use either product daily and the other product at least weekly.
2. Participant is ≤ 24 weeks gestation for conventional smokers and ≤ 36 weeks gestation for e-cig users or dual users.
3. at least 16 years of age
4. able to speak English or Spanish;
5. able to read and sign consent form
6. intent to carry pregnancy to term.
Exclusion Criteria:
1. current drug or alcohol abuse or dependence (other than methadone or buprenorphine maintenance)
2. participant uses combustible marijuana more than 3 times per week (use of edibles/oils is permitted
3. unstable psychiatric disorder
4. unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
5. known congenital abnormality
6. Regular use of tobacco products other than conventional or e-cigs | 8,889 |
Study Objectives
The goal of this study is to determine the feasibility based on toxicity and response rate of giving paclitaxel weekly with concomitant every-other week radiotherapy to limit skin toxicity. This study will also seek to determine the maximally tolerated dose of Navelbine added to this combination when followed by Filgrastim and the dose-limiting toxicities of this regimen.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Paclitaxel, DRUG: Vinorelbine, DRUG: Filgrastim, RADIATION: Radiation
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the male or female breast (male or female) with gross, uncontrolled, unresectable breast and/or chest wall disease including:
1. patients with locally advanced unresectable stage IIIa or IIIb;
2. patients with locally recurrent (including locoregional lymph nodes) disease for which curative surgery is not thought possible
3. patients with metastatic disease AND uncontrolled locoregional disease are eligible.
* Prior chemotherapy allowed, except for nitrosoureas and mitomycin chemotherapy or high dose chemotherapy with marrow or stem cell rescue.
* Prior palliative radiation to sites of metastases allowed (i.e. bone, brain, lung)
* 4 weeks since any prior treatments (excluding hormonal therapy). Concurrent hormonal therapy is not allowed.
* Aged 18 years or older
* CALGB performance status of 0 - 2
* Life expectance of at least 12 weeks
* Initial Laboratory Data:
* ANC Count \> 1500/mm3
* Platelet Count \> 100,000/mm3
* Creatine ≤ 2.0 mg/dl
* Bilirubin ≤ 1.5 mg/dl
* ALT (SGPT) ≤ 3 times the upper limit of normal
* Signed informed consent
Exclusion Criteria:
* Prior breast or chest wall radiation is not allowed unless the proposed site radiation port does not overlap with prior ports
* Subjects must not be pregnant (females able to have children must have negative pregnancy test and agree to use adequate contraception)
* Patients with a documented hypersensitivity to E.coli derived proteins are excluded.
* No other serious medical condition such as uncontrolled infection that in the opinion of the investigators places patient at undue risk for study treatment | 9,320 |
Study Objectives
This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP). Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.
Conditions: Lymphoma, Non Hodgkin
Intervention / Treatment:
DRUG: Cyclophosphamide, DRUG: Doxorubicin, DRUG: Obinutuzumab, DRUG: Polatuzumab Vedotin, DRUG: Prednisolone, DRUG: Prednisone, DRUG: Rituximab
Location: United States, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
All Participants:
* At least one bi-dimensionally measurable lesion, defined as greater than (\>) 1.5 centimeters (cm) in its longest dimension
* Life expectancy of at least 24 weeks
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Adequate hematologic function (unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator)
* Agreement to use highly effective contraception measures. Women of childbearing potential must agree to remain abstinent or use contraceptive measures that result in a failure rate of \<1 percent (%) per year during the treatment period and for at least 12 months for R-CHP arm or for at least 18 months for G-CHP arm after the last dose of study drug. Men must agree to remain abstinent or to use a condom plus an additional contraceptive method that together result in a failure rate of \<1% per year during the treatment period and for at least 5 months after the last dose of study drug
Dose-Escalation Portion of the Study:
* Histologically confirmed B-cell NHL: Participants with newly diagnosed B-cell NHL or relapsed/refractory B-cell NHL are eligible
* No more than one prior systemic treatment regimen for B-cell NHL (single agent anti-cluster of differentiation \[CD\] 20 monoclonal antibody therapy will not be counted as a prior treatment regimen)
* No prior treatment with anthracyclines
Expansion Portion of the Study:
* Previously untreated participants with diffuse large B-cell lymphoma (DLBCL)
* International Prognostic Index (IPI) score of 2-5
Exclusion Criteria:
Dose-Escalation Portion of the Study:
* Diagnosis of primary mediastinal DLBCL
Expansion Portion of the Study:
* Participants with transformed lymphoma
* Prior therapy for NHL
All Participants:
* Prior stem cell transplant
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
* Contraindication to receive any of the individual components of R-CHP or G-CHP
* Current Grade greater than (\>) 1 peripheral neuropathy
* Ongoing corticosteroid use of \>30 milligrams per day (mg/day) of prednisone/prednisolone or equivalent. Participants receiving corticosteroid treatment with less than or equal to (\</=) 30 mg/day of prednisone/prednisolone or equivalent must be documented to be on a stable dose of at least 4 weeks' duration before Cycle 1 Day 1
* Primary central nervous system (CNS) lymphoma
* Vaccination with live vaccines within 6 months before Cycle 1 Day 1
* History of other malignancy that could affect compliance with the protocol or interpretation of results. Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible. Participants with a malignancy that has been treated with surgery alone with curative intent will also be excluded unless the malignancy has been in documented remission without treatment for greater than or equal to (\</=) 5 years before enrollment
* Evidence of significant, uncontrolled concomitant diseases, including renal disease that would preclude chemotherapy administration, or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)
* Significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable angina) or significant pulmonary disease
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks before Cycle 1 Day 1
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
* Positive for hepatitis B or hepatitis C infection
* Prior radiotherapy to the mediastinal/pericardial region
* Pregnant or lactating women
* Recent major surgery within 6 weeks before the start of Cycle 1 Day 1 | 37,300 |
Study Objectives
Lymphomas are classified as Hodgkin's or non-Hodgkin's lymphomas, of which especially the latter represent a heterogeneous group with varying patterns of prognosis, biological behaviour and response to treatment. 18F-FDG PET/CT is useful for staging and response monitoring but has the disadvantage of associated radiation exposure which may not be desirable for young patients. Advanced MRI techniques including diffusion weighted imaging (DWI) are increasingly used for improved lesion detection and characterisation of lymphomas and in the whole-body mode offer a promising radiation-free alternative to CT. Molecular imaging in turn is important in theranostics medicine where detection of therapeutic target is essential. The concept of theranostics has been successfully adapted to management of neuroendocrine tumors (NET) where peptide receptor radiotherapy (PRRT) is offered to patients progressing on treatment with long-acting somatostatin analogues.
Recently in the investigator's hospital a case of diffuse large B-cell lymphoma (DLBCL) was initially misdiagnosed as NET because of high uptake of 68Ga-DOTANOC in pancreatic tumor at PET/CT. A PubMed search revealed a similar case report in bronchial tumor which turned out to be DLBCL (Jain et al. Clin Nucl Med 2014;39:358-359). Bearing these two cases in mind the investigators now aim to systematically study somatostatin receptor status (ssr) by measuring uptake of 68Ga-DOTANOC with PET/CT in patients with newly diagnosed non-Hodgkin's and Hodgkin's lymphoma. The imaging findings will be compared to immunohistochemically determined ssr-subtypes 2,3 and 5 obtained from pre-treatment fresh tumor samples and 18F-FDG PET/CT which is part of standard diagnostic evaluation. Furthermore, whole-body MRI with DWI will be performed before, during and after chemotherapy to define the most sensitive and specific imaging method appropriate for routine diagnosis and follow-up. This study has potential implications for future response monitoring and follow-up imaging techniques in patients with malignant lymphoma and provides additional biologic characterization which may be useful for novel therapeutic approaches such as PRRT.
Conditions: Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin
Intervention / Treatment:
OTHER: 68Ga-DOTANOC PET/CT; Diffusion weighted MRI
Location: Finland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Age: 18-75 years old
* Language spoken: Finnish or Swedish
* Patients with diagnosed untreated non-Hodgkin's or Hodgkin's lymphoma with measurable disease (the diagnosis is based on radiological, histological and clinical grounds)
* Before treatment CT and FDG-PET performed
* Mental status: Patients must be able to understand the meaning of the study
* The patient signs the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
Exclusion Criteria:
* Any medical or psychiatric condition that compromises the subject's ability to participate in the study
* Any other significant disease including liver or renal disease
* Pregnant or lactating women
* Contraindications for MR imaging | 22,968 |
Study Objectives
The purpose of this study is to describe the rate of 3-year progression free survival in men with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and apalutamide, AND who have had testosterone recovery to \>100 ng/dl at 36 months. The hypothesis is that AR inhibition with apalutamide added to standard salvage external beam radiation with androgen deprivation therapy, as well as the addition of 6 cycles of docetaxel, will further prolong progression free survival.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: Apalutamide, DRUG: Androgen deprivation, RADIATION: Salvage radiation therapy, 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:
1. Histologically-confirmed diagnosis of prostate adenocarcinoma. Variants of prostate cancer, including neuroendocrine features and small cell carcinoma of the prostate, are not permitted.
2. Gleason sum of 7 (with pT3 disease or positive margins or positive nodes \[4 or fewer\]), 8, 9, or 10 based on the radical prostatectomy specimen
3. PSA relapse within 4 years of prostatectomy defined by persistently detectable or rising PSA after surgery.
4. Evidence of disease recurrence or progression as evidenced by a PSA \> 0.20. This requires 2 consecutive rises in PSA, at least 1 week apart, over the post-prostatectomy nadir OR one PSA value above 0.20 ng/mL IF the patient failed to achieve a post-prostatectomy nadir of \< 0.2 ng/mL.
5. Age ≥ 18 years
6. Karnofsky performance status ≥ 80
7. Adequate laboratory parameters
* Adequate bone marrow function: ANC ≥1.5 x 109/L, Platelets ≥100 x 109/L, Hb \>9g/dL
* AST/SGOT and ALT/SGPT ≤ 2.5 x Institutional Upper Limit of Normal (ULN)
* Serum bilirubin ≤ 1.5 x Institutional ULN (In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5xULN, measure direct and indirect bilirubin and patient is eligible if direct bilirubin ≤ 1.5xULN).
* Glomerular filtration rate (either estimated or calculated from 24-hour urine collection) ≥ 45 mL/min
* Serum potassium ≥3.5 mmol/L
8. A minimum of 4 weeks from any major surgery prior to Cycle 1 Day 1.
9. Ability to swallow, retain, and absorb oral medication.
10. Ability to understand and the willingness to sign a written informed consent document.
11. Must use a condom if having sex with a pregnant woman.
12. Male patient and his female partner who is of childbearing potential must use 2 acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at screening and continuing throughout the study period and for 3 months after final study drug administration.
Exclusion Criteria:
1. Radiographic evidence of metastatic disease. Patients with node-positive disease (≤4 positive nodes) at the time of radical prostatectomy are eligible. Patients with pelvic nodes less than 1.5 cm by short axis at the time of screening are eligible. Patients with any enlarged lymph nodes in the retroperitoneum or above the aortic bifurcation or with pelvic nodes ≥ 1.5 cm must be excluded.
2. PSA ≥ 4.0 ng/mL.
3. Testosterone level ≤ 100 ng/dL.
4. More than 1 month of prior hormone exposure or hormone exposure within 30 days of enrollment (up to 1 month of prior LHRH agonist and/or anti-androgen therapy as neoadjuvant therapy prior to prostatectomy is allowed). Prior enzalutamide, apalutamide, ketoconazole, abiraterone, or TAK700 for prostate cancer are prohibited. Prior antiandrogen therapy (including but not limited to bicalutamide, flutamide, nilutamide, enzalutamide, and apalutamide) and prior estrogen therapy (including estrogen patch) are not allowed. All investigational agents are prohibited within 30 days of enrollment.
5. The following medications are prohibited within 2 weeks of enrollment and while on study drug:
* 5 α-reductase inhibitors (finasteride, dutasteride);
* Biologic or other agents with anti-tumor activity against prostate cancer;
* Systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone; oPremedication with systemic glucocorticoids greater than the equivalent of 10 mg per day of prednisone is permitted prior to docetaxel infusions.
* Androgens (testosterone, dihydroepiandrosterone \[DHEA\], etc.)
6. Prior immunotherapy including sipuleucel-T.
7. Prior systemic chemotherapy (docetaxel, cabazitaxel, estramustine, other cytotoxic agents)
8. History of solid organ or stem cell transplantation.
9. History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, prior head or traumatic brain injury with loss of consciousness, prior or current space-occupying lesion in the brain). Also, history of loss of consciousness or transient ischemic attack within 12 months of Day 1 visit.
10. Known or suspected brain metastasis or active leptomeningeal disease.
11. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g., active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol.
12. Severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (eg, pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to enrollment
13. Sustained uncontrolled hypertension (\>150/90 average over 1 week) despite optimal medical management
14. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of apalutamide or increase the risk of radiation (e.g., uncontrolled nausea, vomiting, diarrhea, malabsorption syndromes, prior small bowel resection, or inflammatory bowel disease).
15. Patients who have received prior prostate or pelvic radiotherapy, including external beam or brachytherapy.
16. Patients who have not recovered from side effects of prior systemic therapy prior to Cycle 1 Day 1.
17. Use of medications known to lower the seizure threshold within 4 weeks prior to study entry.
18. Patients unable or unwilling to abide by the study protocol or cooperate fully with the investigator. | 12,483 |
Study Objectives
The most frequently used products in CHE are doxorubicin (36%), cisplatin (31%), and epirubicin (12%). But until recently, there were no obvious reasons to use one product over another. In fact, systemic chemotherapy is considered ineffective in HCC \[hepatocellular carcinoma\], which does not allow any argument in favour of the product. Moreover, 2 randomised trials comparing the molecules (doxorubicin vs. epirubicin) proved to be negative in terms of survival.
Cytotoxicity of different anticancer agents on HCC cell lines have been compared in order to select the best candidate for CHE. Eleven chemotherapy molecules have been tested, including those more frequently used in CHE. Among them, idarubicin (an anthracycline) proved to be the most effective in vitro by far. The superiority of idarubicin (as opposed to doxorubicin) was noted especially on the SNU-449 line, which is known for its resistance to several chemotherapy agents. The best cytotoxicity of idarubicin can be explained by 2 mechanisms: 1) idarubicin has a better intracellular penetration than the other anthracyclines. This is probably due to its more considerable lipophily, facilitating thus its passage through the membrane made up of a double lipid layer, 2) idarubicin is resistant to the multidrug resistance system (MDR). The MDR mechanism, which is often noted in HCC, consists of membrane pumps transporting the molecule outside the cell. These two particularities could explain a more significant accumulation of idarubicin in the HCC cells, and thus better efficacy. It is interesting to note that orally administered idarubicin (5 mg/day for 21 days) has proved to be less toxic and is effective in HCC. Currently, idarubicin is used to treat leukaemia. Its toxicity profile (especially, haematological and cardiac) is known.
On these grounds, A pilot study has been conducted in order to assess the tolerance and efficacy of lipiodol-based CHE using a 10 mg dose of idarubicin in 21 patients with unresectable HCC. These preliminary data reveal that CHE with idarubicin is effective and less toxic.
Idarubicin can be loaded in microbeads. A phase I study (IDASPHERE) has been conducted on DC Beads® microbeads (300-500µm) loaded with idarubicin (dose increased from 5 to 25 mg). The DLT \[dose-limiting toxicity\] and MTD \[maximum tolerated dose\] have been determined in 21 patients using a CRM. The MTD of idarubicin was assessed at 10 mg. In our study, the idarubicin-loaded beads did not give rise to any specific toxicity-related problem. The 10 mg dose is compatible with the known toxicity profile of idarubicin: cumulative cardiotoxicity of doxorubicin is noted from 550 mg/m², whereas that of idarubicin is noted from 93 mg/m². There is thus a 5.9:1 ratio between their cumulative toxicities. The most frequently used dose (and also the weakest one) for the doxorubicin-based CHE is 50 mg. The equivalent of the idarubicin dose would thus be: 50 mg (doxorubicin) / 5.9 (doxorubicin/idarubicin ratio) = approx. 10 mg of idarubicin.
It has been already demonstrated that hepatic extraction of idarubicin is better than those of doxorubicin and daunorubicin in an animal sarcoma model. In this study, AUC 0-48h and AUC 0-72h were 1.35 times higher with idarubicin, proving that its intra-hepatic penetration was 35% higher.
The randomised phase II PRECISION V study compared conventional CHE (cCHE) with CHE by doxorubicin beads (DC Bead®) in patients with HCC. It is currently the largest randomised trial on CHE published. The PRECISION V data can be thus used to compare the other studies in terms of efficacy and tolerance.
To continue our preliminary study and the phase I IDASPHERE study, investigators wish to assess thus the efficacy and confirm the tolerance of idarubicin-loaded beads for the CHE of HCC according to a protocol similar to PRECISION V, as part of a single-arm phase II study.
Conditions: Liver Cancer
Intervention / Treatment:
DRUG: idarubicin, DEVICE: Dc- Beads 300-500µm
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* - Histologically diagnosed HCC or HCC diagnosed according to the EASL criteria
* Measurable targets according to the mRECIST v1.1 criterion
* Preserved liver function (in case of Child-Pugh A or B7 cirrhosis)
* Tumour not subject to interventive care (liver transplant, surgical resection or percutaneous destruction)
* BCLC A/B without portal or extra-hepatic invasion
* No prior treatment by chemotherapy, radiotherapy or transarterial embolisation (with or without chemotherapy)
* Age ≥ 18 years
* WHO 0 or 1
* Laboratory test: platelets ≥ 50,000 mm3, N ≥ 1,000/mm3, creatininaemia ≤ 150 µmol/L, PT ≥ 50%
* No heart failure (isotope or ultrasound VEF \> 50%)
Exclusion Criteria:
* - Advanced tumour (vascular or extra-hepatic invasion including brain metastasis or diffuse HCC with liver invasion \> 50%)
* History of other type of cancer except cancer known to be in remission for more than 5 years (in this case, HCC histological proof is required), or basal-cell carcinoma or in situ cervix uteri cancer properly treated with curative treatment
* Advanced liver disease (Child B8, B9 and C, bilirubinaemia \> 3 mg/dL, SGOT and SGPT \> 5 x ULN or 250 U/L)
* Previous treatment by idarubicin and/or doxorubicin
* Idarubicin contraindications (cardiopathy with myocardial failure, serious kidney or liver failure, yellow fever vaccine)
* Concurrent disease or uncontrolled severe clinical condition
* Uncontrolled severe infection
* Patient requiring long-term anticoagulant treatment
* Thrombosis of the portal vein or a 3-segment region or more
* Hepatofugal portal venous flow
* Presence of serious atheromatosis
* Presence of collateral vascular ways potentially affecting the normal regions during embolisation
* Presence of arthritis of the hepatic artery branches to be treated
* Presence of arterioportal or arterial subhepatic fistula that cannot be embolised by coils
* Pregnancy or breastfeeding
* Absence of effective contraception (for men and women of childbearing age)
* Patient who cannot be regularly monitored on account of psychological, social, family- or geography-related reasons
* Concomitant participation of a patient in another study | 24,131 |
Study Objectives
This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of their breast cancer.
Conditions: Fibrosis
Intervention / Treatment:
DRUG: Pentoxifylline, DRUG: Vitamin E
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Patients with histologically documented cancer of the breast or DCIS or head and neck referred for definitive radiation with curative intent.
* No evidence of metastatic disease.
* Minimum life expectancy of at least 12 months.
* Aged greater than 20 years.
* If female, pregnancy excluded.
* No documented history of collagen vascular disease.
Exclusion Criteria:
* Cognitively impaired patients
* Prisoners
* No histology available
* Documented metastatic disease
* Allergy to Trental
* Life expectance of less than 12 months.
* Aged less than 20 years
* Collagen vascular disease present
* Pregnant
* History of liver disease
* Use of anticoagulants | 30,424 |
Study Objectives
This phase II trial studies the side effects and best dose of venetoclax and romidepsin to see how well it works in treating patients with mature T-cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Venetoclax and romidepsin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Conditions: Anaplastic Large Cell Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma
Intervention / Treatment:
OTHER: Laboratory Biomarker Analysis, DRUG: Romidepsin, DRUG: Venetoclax
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:
* Documented informed consent of the participant and/or the legally authorized representative
* Be willing to provide tissue
* Eastern Cooperative Oncology Group (ECOG) =\< 2
* Resolution of all acute toxic effects of prior therapy or surgical procedures to Common Terminology Criteria for Adverse Events (CTCAE) grade =\< 1 (except alopecia)
* Failed at least 2 prior systemic therapies. For anaplastic large cell lymphoma (ALCL) histologies this must include failure or intolerable side effects of brentuximab vedotin
* Histologically confirmed peripheral T-cell lymphoma (PTCL) as defined by the World Health Organization (WHO) criteria 2016, excluding cutaneous T-cell lymphoma (CTCL); transformed mycosis fungoides is allowed
* Measurable disease defined as:
* Computed tomography (CT)/magnetic resonance imaging (MRI)/ or positron emission tomography (PET) scan, with at least one nodal site of disease which is 1.5 cm in longest dimension, and/or spleen \> 13 cm in vertical length, and/or diffuse enlargement of liver with or without focal nodules (Lugano 2014); extra nodal sites with biopsy proven abnormal lesions are allowed including skin
* Patients with only bone marrow involvement will be acceptable
* Prior stem cell transplant allowed
* If allogeneic hematopoietic cell transplantation (HCT) must have recovered from acute toxicity
* Cannot have active acute or chronic graft versus host disease (GvHD) and must be off immunosuppressive therapies
* Absolute neutrophil count (ANC) \>= 1,000/mm\^3 (to be performed within 14 days prior to day 1 of protocol therapy)
* NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement
* Exception: Unless documented bone marrow involvement by lymphoma
* Platelets \>= 30,000/mm\^3 (to be performed within 14 days prior to day 1 of protocol therapy)
* NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement
* Exception: Unless documented bone marrow involvement by lymphoma
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (=\< 3 x ULN for Gilbert's syndrome or documented hepatic involvement by lymphoma) (to be performed within 14 days prior to day 1 of protocol therapy)
* Aspartate aminotransferase (AST) =\< 3 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
* If hepatic involvement by lymphoma: AST =\< 5 x ULN
* Alanine aminotransferase (ALT) =\< 3 x ULN (to be performed within 14 days prior to day 1 of protocol therapy)
* If hepatic involvement by lymphoma: ALT =\< 5 x ULN
* Creatinine clearance of \>= 50 mL/min per 24 hour urine or the Cockcroft-Gault formula (to be performed within 14 days prior to day 1 of protocol therapy)
* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test
* If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
* Agreement by WOCBP and males of childbearing potential\* to use an adequate method of birth control (hormonal contraception is inadequate) or abstain from heterosexual activity for the course of the study through 90 days after the last dose of protocol therapy
* Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only)
Exclusion Criteria:
* Bcl2 inhibitors
* Any systemic anti-lymphoma therapy, including monoclonal antibody within 28 days or 5 half-lives (whichever is shorter) of initiating protocol therapy
* Radiation and/or surgery (except lymph node or other diagnostic biopsies) within 14 days prior to day 1 of protocol therapy
* Short course systemic corticosteroids for disease control, improvement of performance status or non-cancer indication within 7 days prior to day 1 of protocol therapy; stable ongoing corticosteroid use (i.e. at least 30 days) up to an equivalent dose of 20 mg of prednisone is permissible
* Strong or moderate CYP3A inhibitors within 7 days prior to day 1 of protocol therapy
* Strong or moderate CYP3A inducers within 7 days prior to day 1 of protocol therapy
* P-gp inhibitors within 7 days prior to day 1 of protocol therapy
* Narrow therapeutic index P-gp substrates within 7 days prior to day 1 of protocol therapy
* Any other investigational agent or used an investigational device within 21 days prior to day 1 of protocol therapy
* Prior surgery or gastrointestinal dysfunction that may affect drug absorption (e.g., gastric bypass surgery, gastrectomy)
* Active human immunodeficiency virus (HIV) or hepatitis C virus (HCV) or hepatitis B virus (HBV); subjects who have an undetectable HIV viral load with CD4 \> 200 and are on highly active antiretroviral therapy (HAART) medication are allowed; subjects who are positive for hepatitis B core antibody or hepatitis B surface antigen must have a negative polymerase chain reaction (PCR) result before enrollment; those who are PCR positive will be excluded; patients who have had hepatitis C but have finished treatment and are PCR negative will be allowed (testing to be done only in patients suspected of having infections or exposures)
* Concurrent malignancy requiring active therapy
* Known central nervous system or meningeal involvement (in the absence of symptoms, investigation into central nervous system involvement is not required)
* Congestive heart failure (CHF) that meets New York Heart Association (NYHA) class II to IV definitions
* Patients with known cardiac abnormalities such as:
* Congenital long QT syndrome
* QTc (corrected QT interval on electrocardiogram \[ECG\]) interval \> 480 milliseconds
* Any cardiac arrhythmia requiring anti-arrhythmic medication
* Patients with a history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest, unless currently addressed with an automatic implantable cardioverter defibrillator (AICD)
* Active infection requiring systemic therapy
* Unable to swallow capsules, has a partial or small bowel obstruction, or has a gastrointestinal condition resulting in a malabsorptive syndrome (e.g. small bowel resection with malabsorption)
* WOCBP: Pregnant or breastfeeding
* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
* Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics) | 18,487 |
Study Objectives
Background To optimise cancer outcome in Denmark, cancer diagnostic pathways should, beside cancer patient pathways (CPP) for alarm symptoms, also include a pathway for patients with vague and non-specific symptoms. Research has demonstrated that 50% of all cancers do not qualify for specific CPPs, although the majority of patients initially present symptoms in general practice.
Hypothesis Direct access to an abdominal 'yes-no' pathway is feasible in general practice. Aim The aim of this study is to assess the implementation and clinical implications of direct access to an abdominal 'yes-no' pathway for primary care patients with vague and non-specific abdominal symptoms Materials and methods The study is a feasibility study in which all general practitioners (GPs) in the municipality of Silkeborg in Central Denmark Region are offered direct access to a newly developed abdominal ´yes-no´ pathway for both men and women aged 30 years or above, who present vague and non-specific abdominal symptoms in primary care. The abdominal ´yes-no´ pathway consists of: 1) Medical and objective examination, 2) Selected blood samples and a Fecal Immunochemical test (FIT), and 3) Abdominal ultrasound (US) and transvaginal US (TVUS) (for women).
Perspectives This study will provide important knowledge on how to improve abdominal cancer diagnostics in general practice.
Conditions: Cancer, Primary Health Care
Intervention / Treatment:
DIAGNOSTIC_TEST: Abdominal ´yes-no´ pathway
Location: Denmark
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* GPs in the municipality of Silkeborg can refer patients with the following criteria to Silkeborg Regional Hospital:
Men and women ≥30 years old presenting with vague and non-specific abdominal symptoms for at least 3-4 weeks
Exclusion Criteria:
* Men or women who fulfil access criteria for the CPPs. | 24,586 |
Study Objectives
RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways and combining it with chemotherapy before surgery may kill more tumor cells. It is not yet known which radiation therapy regimen combined with chemotherapy with or without surgery is more effective for head and neck cancer.
PURPOSE: Randomized phase III trial to compare two different radiation therapy regimens combined with cisplatin with or without surgery in treating patients who have stage III or stage IV head and neck cancer.
Conditions: Head and Neck Cancer
Intervention / Treatment:
DRUG: cisplatin, RADIATION: Standard fractionation RT, RADIATION: Accelerated fractionation radiation therapy, PROCEDURE: Conventional surgery for select patients
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | DISEASE CHARACTERISTICS:
* Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
* Stage III or IV (T2, N2-3, M0 or T3-4, any N, M0)
* No metastases below the clavicle or more distant by clinical exam or radiology
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.5 mg/dL
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) no greater than 2 times upper limit of normal
Renal
* Creatinine no greater than 1.5 mg/dL
* Creatinine clearance at least 50 mL/min
* Calcium normal
Cardiovascular
* No symptomatic coronary artery disease (angina)
* No myocardial infarction within the past 6 months
Other
* No other invasive malignancy within the past 3 years except nonmelanoma skin cancer
* No simultaneous primary tumors
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the head and neck except radioactive iodine therapy
Surgery
* No prior surgery to the primary tumor or nodes except diagnostic biopsy or nodal sampling of neck disease
* No radical or modified neck dissection | 6,670 |
Study Objectives
This study looks at patients with advanced lung cancer. Participants in this study will be randomized into two groups. The first group will have radiation plus a drug (pembrolizumab). The second group will have only the drug (pembrolizumab). Tumors of participants will be measured to see if the addition of radiation changes the growth of the tumor compared to the drug alone.
Conditions: Stage IV Non-Small Cell Lung Cancer
Intervention / Treatment:
DRUG: Pembrolizumab, RADIATION: Single Fraction Radiation Therapy
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:
* Be willing and able to provide written informed consent/assent for the trial.
* Have measurable disease based on RECIST 1.1.
* Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor and primary investigator.
* Have a performance status of ≤1 ECOG Performance Scale.
* Demonstrate adequate organ function
* Absolute neutrophil count (ANC) ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin ≥ 9g/dL
* Serum creatinine or measured ≤1.5 times the upper limit of normal (ULN) or measured or calculated creatinine clearance ≥ 60 mL/min for subjects with creatinine levels \>1.5 times the institutional ULN
* Serum total bilirubin ≤ 1.5 X ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels \> 1.5 ULN
* AST (SGOT) and ALT (SGPT) ≤ 2.5 times ULN or ≤ 5 times ULN for subjects with liver metastases
* Albumin ≥ 2.5 mg/dL
* Have one measurable lesion of at least 1 cm outside the planned radiation field (defined as not receiving direct beam from any of the treatment portals).
* Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Female subjects of childbearing potential must be willing to use an adequate method of contraception - Contraception, for the course of the study through 120 days after the last dose of study medication.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject
* Male subjects of childbearing potential must agree to use an adequate method of contraception- Contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.
Exclusion Criteria:
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
* Has a known history of active TB (Bacillus Tuberculosis)
* Hypersensitivity to pembrolizumab or any of its excipients.
* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
* Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
* Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
* Patient who have previously received radiation overlapping with the current planned radiation treatment fields are ineligible. Overlap is defined as any tissue falling within the direct path of both prior and current planned radiation fields.
* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Patients with active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks and, have no evidence of new or enlarging brain metastases and also are off steroids 3 days prior to dosing with study medication. Stable brain metastases by this definition should be established prior to the first dose of pembrolizumab.
* Has had prior chemotherapy, within 2 weeks prior to study treatment. Patients on targeted therapy (tyrosine kinase inhibitor) may go on the study after 5 days off therapy.
* Patients who have not recovered (i.e., ≤ Grade 2 or at baseline) from adverse events due to a previously administered agent.
--Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
* Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non-infectious pneumonitis.
* Has an active infection requiring systemic therapy.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
* Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C.
* Has received a live vaccine within 30 days of planned start of study therapy.
* Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed. | 39,364 |
Study Objectives
Background: The optimal treatment of anaplastic gliomas is controversial. Standard of care in most centers is still radiotherapy. This phase III study compared the efficacy and safety of radiotherapy vs chemotherapy in patients (pts) with newly-diagnosed, supratentorial gliomas of WHO grade III.
Methods: Pts were randomized 2:1:1 between June 1999 and February 2005 in 34 German centers to receive (i) a 6-week course of radiotherapy (1,8-2 Gy fractions, total dose 54-60 Gy) or (ii) four 6-week cycles of CCNU at 110 mg mg/m2 on day 1, vincristine at 2 mg on days 8 and 29 and procarbazine at 60 mg/m2 on days 8-21 or eight 4-week cycles of 200 mg/m2 temozolomide on days 1-5. Treatment was stopped prematurely at disease progression or occurrence of unacceptable toxicity. At this time or at disease progression, treatment in the radiotherapy group was continued with one of the chemotherapies (1:1 randomization) and with radiotherapy in both chemotherapy groups. The primary endpoint was time-to-treatment-failure (TTF) defined as progression after radiotherapy and one chemotherapy in either sequence, or any time before if further therapy could not be employed. Assuming a 50% improvement in TTF of starting with chemotherapy, 318 pts were to be enrolled to provide 80% power to achieve statistical significance at a one-sided level of 0.05.
Conditions: Anaplastic Astrocytoma, Oligodendroglioma, Oligoastrocytoma
Intervention / Treatment:
DRUG: Temozolomide, RADIATION: Focal radiotherapy
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* written informed consent
* centrally confirmed anaplastic glioma according to the WHO-classification 1998/2000
* age ≥ 18 years
* Karnofsky performance status (KPS) of 70 or higher
* no prior systemic chemotherapy or radiation therapy of the brain
* no HIV infection
* adequate bone marrow reserve, liver function, and renal function
* Patients on corticosteroids had to be on a stable or decreasing dosage within the 14 days prior to randomization
Exclusion Criteria:
* Glioblastoma
* infratentorial localization of the tumor
* pregnancy or lactation period
* serious medical or neurological comorbidity
* additional malignancy requiring radio- or chemotherapy
* known hypersensitivity against study drugs
* inability to swallow
* frequent emesis
* psychological. familial, sociological or geographical situations impairing compliance with F/U examinations
* parallel participation in other studies | 24,779 |
Study Objectives
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device.
Conditions: Squamous Cell Carcinoma
Intervention / Treatment:
RADIATION: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Location: Israel
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Histopathological confirmation of squamous cell carcinoma.
2. Tumor size ≤ 5 centimeters in the longest diameter.
3. Age over 18.
4. Women of childbearing potential will have evidence of negative pregnancy test.
5. Life expectancy of more than 6 months.
6. Performance status 2 (ECOG scale) or less.
7. Signed informed consent form.
Exclusion Criteria:
1. Tumor maximal diameter \> 5 centimeters.
2. Tumor of Keratoacanthoma histology.
3. Performance status ≥ 3 (ECOG scale).
4. Patients with moribund diseases, autoimmune diseases or vasculitis.
5. Patients under immunosuppressive and/or corticosteroid treatment.
6. Volunteers that participated in other studies in the past 30 days. | 39,247 |
Study Objectives
Tumors of the spine can be described as primary, meaning that the tumor originated from cells normally found in the spine, or metastatic, cells from another area of the body that have spread to the spine. Metastatic tumors are more common than primary tumors. Tumors of the spine can press against the spinal cord and interfere with information traveling down from the brain to the nerves of the spinal cord. As a result, patients with spinal tumors can suffer from loss of movement and sensation within areas of the body below the tumor. In addition, tumors of the spine are typically painful conditions.
Presently, the treatment of choice for spinal tumors is radiation therapy. However, many tumors of the spine become resistant to radiation therapy. In addition, because the spinal cord is often so close to the tumor it can be damaged by the radiation.
Absolute (100%) ethanol is commonly known as "alcohol". It is the same kind of alcohol found in alcoholic beverages. When pure alcohol is injected directly into a tumor it can destroy cells and blood vessels. Because of this feature, researchers would like to test the effectiveness of alcohol in treating patients with spinal tumors.
Researchers believe that intratumoral ethanol injection is a treatment worth studying more closely because it is minimally invasive, has been proven to be an effective treatment for other types of metastatic tumors, can be used repeatedly, and does not interfere with other treatments such as surgery.
In addition to testing the effectiveness of intratumoral ethanol injection, this study will attempt to determine the causes of pain associated with spinal tumors.
Conditions: Hemangioma, Neoplasm Metastasis, Spinal Neoplasm
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Patients must have a vertebral tumor documented by MRI.
Vertebral height must be at least 50 percent of adjacent vertebrae.
Patients must be symptomatic from their spinal tumor. Treatment attempts to reduce the size of, or eliminate, their tumors and to relieve their symptoms. The treatment of the vertebral tumor must be indicated based on the patient's condition.
Prior surgical or radiation therapy for the vertebral tumor will not result in exclusion from the study if there is radiographic evidence of tumor and there is evidence of persistent local pain, epidural compression, or neurological deterioration related to the vertebral tumor.
The patient must be able to comprehend the risks of the therapy and must be able to give informed consent.
Pregnancy will exclude participation due to the radiation exposure involved in this protocol.
Bleeding disorders will exclude a patient from the protocol unless the disorder can be corrected prior to treatment.
Patients must have no contraindications to MRI scanning.
Patients undergoing ethanol injection in the x-ray department must be able to lay prone for at least one hour with intravenous sedation and analgesia.
Patients whose tumors have not responded to radiation therapy will be candidates for ethanol infusion.
Patients with tumors in areas that have received maximal radiation doses to the spinal cord will be candidates for ethanol infusion.
Patients whose poor general condition precludes open surgery will be candidates for ethanol infusion.
Patients who wish to avoid the morbidity and potential mortality of open surgery will be candidates for ethanol injection.
Patients with radioresistant tumors such as melanoma or prostate carcinoma are candidates for ethanol infusion even if they have not undergone prior irradiation.
Patients with radiation-sensitive spinal tumors such as breast, kidney, and lung carcinoma, lymphoma, myeloma, Ewing's sarcoma, neuroblastoma, seminoma will not be entered into the protocol unless their tumors have either responded to radiation or lie at spinal cord levels that have already received maximal tolerable radiation doses.
Patients with less than a 2 month life expectancy will be excluded.
Patients with symptomatic vertebral metastases at more than 3 spinal levels will be excluded.
Patients with asymptomatic vertebral metastases will be excluded. | 1,588 |
Study Objectives
The purpose of this study is to determine whether combined endurance and resistance training can improve muscle strength in children and adolescents with cancer during the intensive treatment phase.
Conditions: Pediatric Oncology
Intervention / Treatment:
BEHAVIORAL: Exercise Training
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Malignant Tumor
* Medical Treatment in the Center for Pediatrics, Hematology, Oncology and Hemostaseology Mainz (Germany)
* \> 3 years
* Signed Informed Consent
Exclusion Criteria:
* Functional and/or cognitive limitations which limit performance during training
* Orthopedic condition which hinders to adequately participate in exercise training
* Heart failure (NYHA III-IV)
* Partial or global respiratory failure
* Symptomatic coronary disease
* Serious therapy-refractory hypertonia
* Sustainable thrombocytopenia \<10.000/µl, f. ex. therapy-refractory autoimmune thrombocytopenia
* Hereditary or acquired thrombocytopenia or coagulation disturbance
* Uncontrolled cerebral spasm
* CNS metastases
* Medical or psychological condition which does in the doctors opinion not allow participation in sport activity | 10,930 |
Study Objectives
The study is designed to determine whether an accelerated course of hypofractionated radiation therapy with daily image guidance and motion assessment/control will allow more effective treatment of poor performance status patients with stage II-III NSCLC, who would benefit from local therapy compared to standard radiation therapy (60 Gy in 2 Gy per fraction).
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
RADIATION: Radiation Therapy, RADIATION: Conventional radiation
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* All patients must be willing and capable to provide informed consent to participate in the protocol.
* Patients must have appropriate staging studies identifying them as AJCC stage II or III non small cell lung cancer, (according to AJCC Staging, 6th edition; see appendix III), or recurrent non small cell lung cancer. Histologic confirmation of cancer will be required by biopsy or cytology within 6 months of study entry.
* Patients must have the potential for benefit from local therapy (at the discretion of the investigator).
* The patient's Zubrod performance status must be 2 or greater OR patients with Zubrod performance status 0-1 and weight loss \>10% are considered eligible. In addition, patients determined to be medically unfit or refusing combined modality therapy are eligible.
* Age ≥ 18.
* Patients must have measurable or evaluable disease.
* Women of childbearing potential and male participants must agree to use an effective method of contraception.
* Patients must sign study specific informed consent prior to study entry.
* Patients must not have plans for concurrent chemoradiation therapy.
* Patients must complete all required pretreatment evaluations
Exclusion Criteria:
* Total (aggregate) gross tumor volume \> 500 cm3 (500 cc's or 0.5 Liters)
* Prior radiotherapy to the region of the study cancer that would result in direct overlap of radiation therapy fields.
* Chemotherapy given within one week of study registration.
* Pregnant or lactating women, as treatment involves unforeseeable risks to the embryo or fetus. | 41,274 |
Study Objectives
A prospective observational study on italian women undergoing ulipristal acetate (uPa) therapy for symptomatic myomas and its impact on symptomatology and moreover on myomas architecture. We also evaluate changes in the endometrial pattern of selected women.
Conditions: Myoma, Uterine Bleeding, Dysfunctional, Uterine Bleeding Heavy, Dysmenorrhea, Endometrium Hyperplasia
Intervention / Treatment:
DIAGNOSTIC_TEST: Transvaginal ultrasonographic examination
Location: Italy
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* number of myomas from 1 to 4
* heavy menstrual bleeding
* conservative treatment request
Exclusion Criteria:
* concurrent endometrial pathology
* post-menopausal status
* hepatic pathology
* endocrine or metabolic disorders | 2,375 |
Study Objectives
MEK162 has shown significant inhibition of tumor growth as a single agent in NSCLC xenograft models in mice and human cancer cells in vitro, which have KRAS and/or other mutations. These data suggest that MEK162 may provide a potential benefit in cancer indications harboring these mutations. MEK162 is currently being investigated in phase I clinical testing and has been well tolerated up to an MTD of 45mg BID in cancer patients.
There has been little change in survival benefit for patients with non-small cell lung cancer in recent years. Emerging new treatment options relying on molecular and genetic markers are being studied extensively. Thus, there has been a shift to manage non-small cell lung cancer with molecular targeted therapies in combination with standard chemotherapy. This study will be targeting patients with KRAS mutations.
Conditions: Lungcancer
Intervention / Treatment:
DRUG: Binimetinib, DRUG: Pemetrexed, DRUG: Carboplatin
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Subjects eligible for enrolment on the study must meet all of the following criteria:
* Patients with histologically confirmed non-squamous EGFR wild-type, ALK-rearrangement negative carcinoma of lung. Patients with neuroendocrine carcinoma, mixed small and non-small cell carcinoma or squamous carcinoma are not eligible.
* Tissue available for KRAS mutation status analysis.
* Patients must have metastatic disease (Incurable stage IIIB/stage IV).
* Patients must have clinically and/or radiographically documented measurable disease. At least one site of disease must be unidimensionally measurable by RECIST v1.1 as follows (Eisenhauer et al.):
CT-scan, physical exam ≥10 mm Chest X-ray ≥20 mm Lymph node short axis ≥15 mm
* All radiology studies must be performed within 28 days prior to registration (35 days if negative).
* Lesions in previously irradiated areas should not be selected unless there is clear evidence of progression in such lesions.
* Patients may not have received any prior systemic treatment for metastatic NSCLC. Patients who have received adjuvant treatment or chemoradiation for stage III disease should have completed this ≥12 months prior to study enrollment.
* Patients with stable CNS metastases are permitted if stability of disease is documented with imaging ≥28 days after treatment completion, are and off corticosteroids by day 1 of study treatment.
* Patients may have had prior malignancy if definitively treated and/or, in the opinion of the investigator, the only active malignancy is NSCLC. Patients with mixed small cell lung cancer histology are excluded. Patients who have received radiotherapy to \>30% bone marrow are excluded. Consult PI if unsure whether second malignancies meet requirements specified above.
* In patients treated for other malignancy, all prior treatment-related toxicities must be CTCAE v4.0 ≤ Grade 1 (except alopecia) at the time of enrollment.
* Able to swallow and retain oral medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels.
* Patients receiving medications or substances that are inhibitors or inducers of CYP1A2, CYP2A19, CYP2B6, CYP3A4 and/or UGT1A1 and UGT1A9 are eligible but these drugs must be used with caution (Appendix C).
Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as http://medicine.iupui.edu/clinpharm/ddis/table.aspx;
* Patients must be aged ≥18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤1
* Adequate organ and laboratory parameters, defined below.
* Laboratory Requirements - within 7 days prior to enrollment:
Haematology: absolute granulocytes ≥1.5 × 109/L platelets ≥100 × 109/L Biochemistry: bilirubin ≤1.25 × institutional upper limit of normal AST(SGOT) ≤2.5 × institutional upper limit of normal /ALT(SGPT) or ≤5 × institutional upper limit of normal in the presence of liver metastases
creatinine clearance ≥45 mL/min/1.73 m2
-Patients must be able to provide Informed Consent based on the details below:
* absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.
Exclusion Criteria:
* History or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR):
* History of RVO or CSR, or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension, uncontrolled systemic disease such as hypertension, diabetes mellitus, or history of hyperviscosity or hypercoagulability syndromes). Patients with prior deep venous thrombosis or pulmonary embolism are permitted.
* Visible retinal pathology as assessed by ophthalmologic exam that is considered a risk factor for RVO or CSR such as:
* Evidence of new optic disc cupping
* Evidence of new visual field defects on automated perimetry
* Intraocular pressure \>21mmHg as measured by tonography
* Any serious and/or unstable pre-existing medical (aside from malignancy exception), psychiatric disorder, or other conditions that could interfere with subjects' safety, obtaining informed consent or compliance to the study procedures, in the opinion of the PI.
* History of interstitial lung disease or pneumonitis.
* Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal metabolic or cardiac disease).
* Any factors that increase the risk of QTc prolongation or risk of arrhythmic events (e.g. congenital long QT syndrome, family history of long QT syndrome, hypokalemia) or baseline QTcB interval ≥480 msec.
* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty, or stenting within the past 6 months or cardiac metastases.
* History or evidence of current clinically significant uncontrolled arrhythmias.
* History or evidence of current ≥Class II congestive heart failure as defined by New York Heart Association (NYHA).
* Known positivity for Hepatitis B surface antigen or Hepatitis C antibody.
* Known Human Immunodeficiency Virus (HIV) infection.
* Treatment refractory hypertension defined as a blood pressure systolic \>140 mmHg and/or diastolic \>90 mmHg which cannot be controlled by anti-hypertensive therapy.
* Subjects with intra-cardiac defibrillators or permanent pacemakers.
* Pregnant or nursing (lactating) women are excluded.
* Female patient of child bearing potential must have a negative serum or urine pregnancy test.
* Women of child-bearing potential must agree to use of appropriate contraceptive methods throughout the study and for 120 days after, These methods include
* Total abstinence or 2 barrier methods or a barrier method plus hormonal method from visit 1 to 120 days after the last dose of treatment.
* Men must agree to use an appropriate method of contraception starting with first dose of study drug through 120 days after the last dose of treatment (see above).
* Whilst not excluded, patients with significant impaired hearing must be made aware of potential ototoxicity and may choose not to be included. If included, baseline audiograms are recommended and should be followed by repeat audiograms prior to cycle 2. | 17,816 |
Study Objectives
The study will assess the efficacy of EP2006 compared to Filgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.
Conditions: Chemotherapy Associated Neutropenia, Breast Cancer
Intervention / Treatment:
DRUG: EP2006, DRUG: Filgrastim
Location: Ukraine, Slovakia, Hungary, Latvia, Czech Republic, Russian Federation
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
1. Patients with histologically proven breast cancer, eligible for neoadjuvant or adjuvant myelosuppressive chemotherapy
2. Women ≥ 18 years of age
3. Estimated life expectancy of more than six months
Exclusion Criteria:
1. Previous or concurrent malignancy except non-invasive non-melanoma skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least ten years prior to study entry
2. Any serious illness or medical condition that may interfere with safety, compliance, response to the products under investigation and their evaluation, e.g.:
Other protocol-defined inclusion/exclusion criteria may apply. | 31,443 |
Study Objectives
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT Neuro)
This post-market surveillance study is conducted to provide post market surveillance information regarding long-term performance and ease of use of the Polyganics nerve capping device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
Conditions: Neuroma
Intervention / Treatment:
DEVICE: Neurocap®
Location: Germany, United States, Spain, France, United Kingdom, Sweden, Italy
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
2. Subjects who are able to comply with the follow-up or other requirements.
3. Subjects who are ≥ 18 years old.
4. Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.
5. Subjects with a positive Tinel's sign.
6. Symptomatic neuroma confirmed by pain relief following a 10min ± 2min nerve block with Xylocaine (Lidocaine) - Pain relief defined as minimally 50% reduction in VAS questionnaire score.
7. Subjects that are indicated for surgery to treat symptomatic neuroma.
Exclusion Criteria:
1. Subjects who do not complete the informed consent.
2. Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure on the implant zone or immobilization).
3. Subjects who are unable to comply with the follow-up or other requirements and/or have a life expectancy of less than 24 months.
4. Subjects with congenital neuropathy.
5. Insufficient amount of soft tissue to cover the investigational device, as assessed by the surgeon. Use of the device over a joint is advised against.
6. Subjects who have had historical radiotherapy in the area of the (end-) neuroma.
7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester Poly(68/32\[15/85 D/L\] Lactide-ε-Caprolactone) (PLCL).
8. Proximal nerve end \> 8mm.
9. Pregnancy. | 22,046 |
Study Objectives
The purpose of this study is to learn more about the understanding patients with brain tumors have of their disease and their communication with their physician. Ultimately, we hope to use these findings to improve communication between patients and their doctors.
Conditions: Malignant Glioma
Intervention / Treatment:
BEHAVIORAL: surveys and cognitive tests
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
Patient Inclusion Criteria
* Age greater than or equal to 18
* Diagnosis of any WHO grade III or IV glioma
* Admitted to the inpatient Neurology service
* Has had at least one outpatient visit with a neuro-oncologist at MSKCC Fluent in English
Caregiver Inclusion Criteria
* Age greater than or equal to 18
* Identified by the patient as a relative, friend, or partner with whom he or she has a significant relationship and who provides him or her physical or emotional assistance.
* The patient has himself or herself agreed to participate in this study
Exclusion Criteria:
Patient Exclusion Criteria
* A patient will be excluded if the Glasgow Coma Scale is less than 15. The patient must be oriented to self, age, place, and year, and month.
* Aphasia precluding comprehension and verbalization of consent to participate
* Patients who cannot verbally demonstrate their understanding of the risks, benefits, and alternatives to participating in the study. This evaluation will take place for otherwise eligible and willing participants, and it will be performed by the NP or MD clinician who is obtaining informed consent and will be documented in the medical record.
Caregiver Exclusion Criteria
* No eligible caregivers who can complete the brief assessment in person or via telephone will be excluded | 11,433 |
Study Objectives
Pharmacologic inhibition of RANKL attenuates the development of mammary carcinoma and inhibits metastatic progression in multiple mouse models.
In a retrospective analysis it could be demonstrated that elevated expression of RANK was found in 14.5% of patients overall, with a significant predominance in patients with hormone-receptor-negative disease. Expression of RANK was associated with a higher pathological complete response rate but with a shorter disease-free and overall survival. The ABCSG-18 study showed that adjuvant denosumab reduces clinical fractures, improves bone health, and can be administered without added toxicity.
It appears therefore reasonable to test denosumab, a clinically available antibody against RANKL in patients with hormone-receptor-negative primary breast cancer as an adjunct to neoadjuvant chemotherapy for its ability to increase pCR rate and improve outcome in relation to the expression of RANK.
Conditions: Breast Cancer Female NOS, Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Invasive Ductal Breast Cancer, HER2 Positive Breast Cancer, Inflammatory Breast Cancer, Tubular Breast Cancer Stage III
Intervention / Treatment:
DRUG: Denosumab, DRUG: nab-Paclitaxel, DRUG: Epirubicin, DRUG: Cyclophosphamide, DRUG: Carboplatin, DRUG: Trastuzumab, DRUG: Pertuzumab
Location: Germany
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: NONE | Inclusion criteria:
* Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration from the breast lesion alone is not sufficient. Incisional biopsy or axillary clearance is not allowed. In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.
* Tumor lesion in the breast with a palpable size of 2 cm or a sonographical size of 1 cm in maximum diameter. The lesion has to be measurable in two dimensions, preferably by sonography. In case tumor isn't measurable by sonography, then MRI or mammography is sufficient. In case of inflammatory disease, the extent of inflammation can be used as measurable lesion.
* Patients must have stage cT1c - cT4a-d disease.
* In patients with multifocal or multicentric breast cancer, the largest lesion should be measured.
* Centrally confirmed ER-negative and PR-negative status. Central pathology includes also assessment of HER2, Ki-67, TIL and RANK status on core biopsy. ER/PR negative is defined as ≤1% stained cells and HER2-positive is defined as IHC 3+ or in-situ hybridization (ISH) and according to ASCO-CAP guidelines as of 2013. LPBC (lymphocyte predominant breast cancer) is defined as more than 50% stromal tumour infiltrating lymphocytes. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy has therefore to be sent to the GBG central pathology laboratory prior to randomization.
Exclusion criteria:
* Patients with stages cT1a, cT1b, or any M1.
* Prior chemotherapy for any malignancy.
* Prior radiation therapy for breast cancer.
* History of disease with influence on bone metabolism, such as osteoporosis, Paget's disease of bone, primary hyperparathyroidism requiring treatment at the time of randomization or considered likely to become necessary within the subsequent six months.
* Use of bisphosphonates or denosumab within the past 1 year.
* Significant dental/oral disease, including prior history or current evidence of osteonecrosis/ osteomyelitis of the jaw, active dental or jaw condition which requires oral surgery, non-healed dental/oral surgery, planned invasive dental procedure for the course of the study.
* Previous malignant disease being disease-free for less than 5 years (except CIS of the cervix and non-melanomatous skin cancer).
* Known or suspected congestive heart failure (\>NYHA I) and / or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP \>140 / 90 mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
* Currently active infection.
* Incomplete wound healing.
* Definite contraindications for the use of corticosteroids. | 37,144 |
Study Objectives
The overall purpose of the study is to determine if MEDI-551, when used in combination with salvage chemotherapy, Ifosfamide-carboplatin-etoposide (ICE) or Dexamethasone-cytarabine (DHAP) in patients with relapsed or refractory DLBCL who are eligible for Autologous Stem Cell Transplant (ASCT), has superior efficacy compared to rituximab in the same population.
Conditions: Diffuse Large B-Cell Lymphoma
Intervention / Treatment:
DRUG: MEDI-551 2 mg/kg, DRUG: Rituximab, DRUG: ICE, DRUG: DHAP, PROCEDURE: Autologous Stem Cell Transplant (ASCT), DRUG: MEDI-551 4 mg/kg
Location: Hungary, Germany, United States, Turkey, Israel, Canada, Spain, France, Czechia, Russian Federation, Poland
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL \& Grade III FL
* Relapsed from or refractory to at least one treatment containing rituximab or another anti-CD20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy
* Eligible for ASCT
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy of ≥ 12 weeks
* Adequate hematological function
Exclusion Criteria:
* Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
* Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy
* Prior autologous or allogeneic SCT
* New York Heart Association ≥ Class II congestive heart failure; Clinically significant abnormality on ECG
* History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.
* Evidence of active infection
* Documented current central nervous system involvement by leukemia or lymphoma | 41,317 |
Study Objectives
The Novel Markers Trial will compare the safety, feasibility and effectiveness of two different epithelial ovarian cancer screening strategies that use CA125 and add HE4 as either a first or second line screen. This study is the next step in a larger research effort to develop a blood test that can be used as a screening method for the early detection of epithelial ovarian cancer.
Conditions: Epithelial Ovarian Cancer
Intervention / Treatment:
PROCEDURE: CA125 assay on Abbott Architect i1000SR platform, PROCEDURE: HE4 assay on Architect i1000SR platform, PROCEDURE: Transvaginal Ultrasound
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
Risk Group 1, Women ages 25 - 80:
* The subject has tested positive for a deleterious germ line mutation in BRCA1 or BRCA2.
Risk Group 2, Women ages 35 - 80, Pedigree conditions can be satisfied by multiple primary cancers in the same person:
* The subject has a personal history of breast cancer diagnosed before or at age 50.
* OR the subject has a personal history of bilateral breast cancer
* OR the subject has one first-degree relative with breast cancer diagnosed before or at age 50.
* OR the subject has two breast cancers in the first or second degree relatives, same lineage, with at least one breast cancer diagnosed before or at age 50.
* OR the subject has three or more first or second degree relatives, same lineage, with breast cancer diagnosed at any age.
* OR The family contains at least one ovarian cancer diagnosed at any age in the first or second degree relatives.
* OR the subject is of Ashkenazi ancestry and has had breast cancer diagnosed at any age.
* OR The subject is of Ashkenazi Jewish ethnicity and has one first or second degree relative with breast cancer diagnosed at any age (must be in the same lineage as the Ashkenazi ancestry)
* OR The subject has a male relative with breast cancer diagnosed at any age
* OR The subject has a personal history of a positive genetic test result for a deleterious germline mutation in the P53 gene.
* OR The subject has tested positive for a deleterious germline mutation in one of the DNA mismatch repair (MMR) genes associated with the Hereditary Non-Polyposis Colorectal Cancer Syndrome (HNPCC, also known as Lynch Syndrome) The MMR genes include MLH1, MSH2, MSH6 and PMS2.
* OR the subject has a first or second degree relative with an identified deleterious germline BRCA1 or BRCA2 mutation, but has not yet undergone testing herself.
* OR the subject has a first or second degree relative with an identified deleterious germline MMR gene mutation, but has not yet undergone testing herself.
* OR Probability of carrying a BRCA1 or BRCA2 mutation given family pedigree of breast and ovarian cancers exceeds 20% by any existing BRCA mutational probability model.
Risk Group 3, Women ages 45 - 80:
* Have measurement of CA125, HE4, MMP7 or Mesothelin exceeding the 95th percentile;
* OR have a relative risk of at least 2 based on the EpiRisk logistic regression model including age, family history, and other risk factors.
Exclusion Criteria:
* Removal of both ovaries for any reason.
* History of ovarian, fallopian tube cancer or peritoneal carcinomatosis.
* Currently pregnant.
* Unable or unwilling to provide informed consent.
* Unwilling to provide the name of a physician.
* Unwilling to sign informed consent and/or medical records release form.
* Current untreated malignancy (other than non-melanoma skin cancer).
* Currently receiving adjuvant chemotherapy or radiation therapy for cancer (except tamoxifen or aromatase inhibitors +/- lupron). Patients who are being treated may enroll 3 months after completion of last treatment.
* Intraperitoneal surgery within the last 3 months (laparoscopy or laparotomy).
* A medical condition that would place subject at risk as a result of the blood donation, including but not limited to bleeding disorders, chronic infectious disease, emphysema or serious anemia.
* Subject has a family member who is a carrier of a BRCA or MMR gene mutation and the subject has undergone genetic testing that included the family mutation and no mutation was found, and there are no cases of ovarian cancer in the family. | 22,843 |
Study Objectives
This study is aimed at exploring the use of whole body MRI for early cancer detection in TP53 mutation carriers and population controls, with the hypothesis that more cancers will be detected in the TP53 mutation carrier group. A secondary end-point will be the number of incidental findings detected and subsequent investigations required. A series of questionnaires will be used to assess the psychological impact of screening on both the study and control group.
Conditions: Li-Fraumeni Syndrome
Intervention / Treatment:
OTHER: Whole body MRI, OTHER: Psychological questionnaires
Location: United Kingdom
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Carrier of germline TP53 mutation which, in the view of the geneticist, is not known to be low penetrance OR non-related individual with no personal history of malignancy and no first degree relatives diagnosed with malignancy under the age of 50 years
* Please note, TP53 carrier cohort is complete and no longer open to recruitment
* Age between 18 and 60
* Able to give informed consent
Exclusion Criteria:
* Individual with low penetrance TP53 mutation
* Individual with TP53 variant of unknown significance.
* Previous malignancy diagnosed \< 5 years ago in TP53 carriers (except non-melanomatous skin cancer or cervical CIS) Previous history of malignancy in non-related controls (except non-melanomatous skin cancer or cervical CIS)
* Current symptoms suggestive of malignancy
* Contraindication to MRI (such as non-MR compatible metal implants) as specified by the standard MR safety checklist
* Claustrophobia
* ECOG performance status \>2 | 12,082 |
Study Objectives
To assess changes in pain, physical function, and health-related quality of life in patients with post-amputation neuroma-associated residual limb pain after cooled radiofrequency ablation.
Conditions: Phantom Limb Pain, Neuroma Amputation
Intervention / Treatment:
DEVICE: Cooled Radiofrequency Ablation
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:
1. Age greater than 18 years of age at day of enrollment.
2. Clinical diagnosis lower extremity amputation performed more than 1 year since study enrollment.
3. Residual pain described as burning pain and sensations of movement in the affected amputated limb32.
4. Pain duration of more than 6 months despite a trial of conservative therapy (medications, physical therapy) for 2 months.
5. Ultrasound and / or MRI imaging pathology consistent with clinical symptoms and signs.
6. Greater than 50% pain relief with a diagnostic neuroma block
Exclusion Criteria:
1. Refusal or inability to participate, provide consent, or provide follow-up information for the 12-month duration of the study.
2. Contraindications to diagnostic block or treatment ablation (active infection, bleeding disorders, and pregnancy or breastfeeding, active immunosuppression, participation in another phantom or residual limb pain trial within the last 30 days
3. Non-neurogenic source of residual or phantom limb pain.
4. Active moderate to severe lumbar radiculopathy.
5. Any injection in the residual limb within the last 30 days.
6. Severe uncontrolled medical condition as determined by treating physician.
7. Severe psychological illness.
8. History of Inflammatory arthritis.
9. Malignancy within past 5 years except basal cell or squamous cell skin cancer. 10. Current opioid use exceeding50morphinemilligram equivalents per day.
11. A history of alcohol or drug abuse within past 5 years. 12. Use of any investigational drug within past 30 days. 13. Pending litigation involving participant's residual limb pain. 14. Incarceration | 1,837 |
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.
PURPOSE: This research study is looking at biomarkers in tissue samples from young patients with acute myeloid leukemia previously enrolled on clinical trial POG-9421.
Conditions: Leukemia
Intervention / Treatment:
GENETIC: gene expression analysis, GENETIC: microarray analysis, GENETIC: proteomic profiling, OTHER: laboratory biomarker analysis
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Diagnosis of acute myeloid leukemia, meeting 1 of the following criteria:
* Primary induction failure (i.e., failed to achieve remission within the first 60 days of therapy)
* Relapsed disease (early or late)
* In continuous complete remission
* Previously enrolled on POG-9421
* Tissue samples available
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics | 41,241 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.
PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.
Conditions: Unspecified Childhood Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: ECTEINASCIDIN 743
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 confirmed malignant solid tumor at original diagnosis Refractory to standard treatment or no curative therapy available No CNS tumor No bone marrow metastases (for less heavily pretreated stratum only)
PATIENT CHARACTERISTICS: Age: At least 365 days to 17 years Performance status: Karnofsky 50-100% (for patients older than 10 years) Lansky 50-100% (for patients 10 years and younger) Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 (transfusion independent) Hemoglobin at least 8.0 g/dL (RBC transfusion allowed) Hepatic: Bilirubin no greater than normal SGPT no greater than 2.5 times normal Albumin at least 2 g/dL Alkaline phosphatase normal Gamma glutamyl transferase less than 2.5 times normal Renal: Creatinine no greater than 1.5 times normal OR Creatinine clearance or GFR at least lower limit of normal Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Creatine phosphokinase less than 2 times normal No uncontrolled infection Seizure disorder allowed if well controlled on anticonvulsants No CNS toxicity greater than grade II
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 1 week since prior biologic therapy and recovered At least 1 week since prior growth factor therapy At least 6 months since prior peripheral blood stem cell transplantation and no evidence of graft-vs-host disease For less heavily pretreated stratum: No prior peripheral blood stem cell transplantation Chemotherapy: At least 4 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) and recovered No prior ecteinascidin 743 For less heavily pretreated stratum: No more than 2 prior chemotherapy regimens Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior local palliative radiotherapy (small port) At least 6 weeks since prior substantial bone marrow radiotherapy At least 6 months since prior craniospinal radiotherapy or radiotherapy to 50% or greater of pelvis For less heavily pretreated stratum: No prior craniospinal irradiation of 18Gy or greater No prior irradiation to greater than 50% of pelvis Recovered from toxic effects of prior radiotherapy Surgery: Not specified Other: No concurrent foods or medication that interferes with P-450 metabolism Anticonvulsants allowed | 25,583 |
Study Objectives
To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.
Conditions: Polycystic Ovary Syndrome
Intervention / Treatment:
DRUG: Metformin, DRUG: Placebo
Location: Norway
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* 18-45 years,
* PCOS diagnosis according to Rotterdam criteria
* single, viable, ultrasound verified fetus
* if metformin was used at conception and early pregnancy, at least 7 days of "wash out"
Exclusion Criteria:
* known liver disease or ALAT \> 90 nmol/L
* known renal disease or creatinine \> 110 micromol/L
* diabetes mellitus
* alcohol or drug abuse
* peroral steroid treatment
* cimetidine, anticoagulant or erythromycin treatment at time of inclusion
* not suitable for other reasons | 30,986 |
Study Objectives
The primary objective of this prospective trial will be to assess the effects of dexmedetomidine administration on oxygenation and respiratory function in patients undergoing diagnostic or therapeutic medical thoracoscopy/pleuroscopy for a pleural effusion compared to conventional conscious sedation/monitored anesthesia care (MAC) with midazolam. The secondary endpoint of the study will be to also assess the effects of dexmedetomidine administration on respiratory mechanics and postprocedural complications
Conditions: Pleural Effusions, Chronic, Pleural Effusion, Malignant, Pleural Diseases
Intervention / Treatment:
Location: Greece
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Age ≥ 18 years old
* American Society of Anesthesiologists (ASA) physical status of I-IV
* scheduled to undergo medical thoracoscopy/pleuroscopy.
Exclusion Criteria:
* general anesthesia within 7 days prior to study entry
* received an α2-agonist or antagonist within 14 days before the procedure
* received an intravenous opioid within 1 hour
* received an oral or intramuscular opioid within 4 hours from procedure
* New York Heart Association class ≥3
* acute unstable angina
* acute myocardial infarction (confirmed by laboratory findings) in the past 6 weeks
* heart rate (HR) ≤45-50 bpm
* systolic blood pressure (SBP) ≤90 mm Hg,
* 2nd or/and 3rd-degree Atrioventricular (AV) block (if the patient does not have a pacemaker)
* severe functional liver or kidney disease,
* obesity (body mass index ≥30 kg/m-2)
* severe restrictive interstitial lung disease | 44,011 |
Study Objectives
This study creates a patient registry of patients undergoing contrast-enhances-harmonic endoscopic ultrasound imaging. In order to improve what doctors see on the ultrasound exam, sometimes intravenous contrast can be used to better emphasize the blood flow in a particular organ or lesion. Creating a local database that can be used as a patients registry may help doctors keep track of all patients that undergo contrast-enhanced endoscopic ultrasound procedures and also to monitor for possible procedure adverse events.
Conditions: Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Intervention / Treatment:
OTHER: Electronic Health Record Review
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Male and female patients aged 18 years to 99 years old who were undergo CE-EUS are eligible for study inclusion
* Based on clinical judgement of the advanced endoscopist will include those who present with lesions where increased microvasculature and perfusion visualization with contrast-enhanced harmonic endoscopic ultrasound imaging would be of beneficial for lesion characterization
* Clinical medical stability to undergo sedation for endoscopy and provide informed consent
Exclusion Criteria:
* Medical condition that preclude the patient from having an endoscopic procedure
* Patients who cannot provide adequate research authorization
* Patients with known allergies to ultrasound contrast agents
* Patient who did not receive contrast during endoscopic ultrasound (EUS) exams | 25,035 |
Study Objectives
The aim of the current study was to clarify the relationship between protein intake and health by using a very large, general population cohort study, UK Biobank, to study the associations between reported protein intake (expressed in g/day, g/kg/day and % of total energy intake) and three health outcomes (all-cause mortality, incidence CVD and cancer).
Conditions: Cardiovascular Diseases, Cancer, All-cause Mortality
Intervention / Treatment:
OTHER: None as this is an observational study
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* None
Exclusion Criteria:
* None | 36,229 |
Study Objectives
Brain metastases are the most common adult intracranial tumor, occurring in approximately 10% to 30% of adult cancer patients, and represent an important cause of morbidity and mortality in this population. The standard of care for solitary brain metastasis is surgery followed by whole brain radiation therapy (WBRT). Without WBRT, there are unacceptably high levels of local failure that occur. Local recurrence rates ranged from approximately 45% at 1 year to 60% at 2 years after resection alone. However, aside from improvements in intra-cranial control, it is well documented that WBRT is associated with serious long term side effects, including significant decline in short term recall by as early as 4 months after treatment.
Many centers are now offering patients stereotactic radiosurgery (SRS) to the cavity after resection alone to improve local control while avoiding the negative effects of WBRT. There have been several retrospective studies on the use of SRS to the resection cavity alone, from which the 1 year actuarial local control rates range from 35% - 82%. The high rate of in-field local failure suggests that the current dosing regimen used may not be high enough for adequate local control. Currently, the highest local control rates are approximately 80%, but there may be room for improvement with increased dose without significantly increasing the risk of side effects.
The investigators propose a trial for patients after surgical resection of solitary brain metastases. The purpose of this trial will be to determine the maximum tolerated dose for single fraction SRS to the resection cavity. There will be three groups based on the resection cavity size. Dose escalation enrollment will be done sequentially within each cohort. You will know which cohort and which specific dose level you are randomized to. After treatment, which will take one day, regardless of cohort, you will be followed closely for treatment outcome and possible side effects. You will be asked to complete three quick surveys at each follow-up appointment regarding quality of life and memory in addition to standard of care surveillance brain MRI and physical exam.
Conditions: Brain Metastasis, Neoplasm
Intervention / Treatment:
RADIATION: Radiosurgery dose escalation
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Pathologic proven diagnosis of solid tumor malignancy
* Age ≥ 18
* RPA class I or class II
* Mini Mental Status Exam (MMSE) ≥ 18 prior to study entry
* Karnofsky Performance Status ≥ 70%
* Single brain metastasis status post surgical resection with ≤ 1 cc of residual enhancing tumor
* Up to 2 additional intact brain metastases to be treated with stereotactic radiosurgery (SRS) alone
* Resection cavity volume on planning scan of ≤ 35 cc
* First presentation of brain metastases
* Post-operative MRI within 72 hours of surgical resection
Exclusion Criteria:
* Previous brain radiotherapy (SRS or WBRT)
* RPA class III
* Resection cavity volume \> 35 cc
* Radiosensitive or non-solid (eg. small cell lung carcinomas, germ cell tumors, leukemias, or lymphomas) or unknown tumor histologies
* Concurrent chemotherapy (no chemotherapy starting 14 days before start of radiation to 14 days after completion of radiation)
* Evidence of leptomeningeal disease by MRI and/or CSF cytology
* Current pregnancy
* More than 8 weeks between resection and radiosurgical procedure
* No metastases to brain stem, midbrain, pons, or medulla or within 7 mm of the optic apparatus (optic nerves and chiasm)
* Inability to undergo MRI evaluation for treatment planning and follow-up | 41,206 |
Study Objectives
The goal of this clinical trial is to about in Patients With Advanced Solid Tumors. The main question\[s\] it aims to answer are:
* question 1:Evaluating the tolerability of BH002 injection in Chinese patients with advanced solid tumors
* question 2:Obtain the pharmacokinetic (PK) characteristics of BH002 injection in Chinese patients with advanced solid tumors
Conditions: Solid Tumours
Intervention / Treatment:
DRUG: BH002
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. Age ≥18 years old, male or female.
2. Patients were diagnosed advanced solid tumors by histology or cytology (preferably prostate cancer, gastric cancer, non-small cell lung cancer, breast cancer, esophageal cancer, head and neck squamous cell carcinoma, ovarian cancer, liposarcoma, etc.) whose disease progresses after standard treatment.
3. ECOG score 0\~2, expected survival time ≥3 months.
4. Have adequate hematology and organ function, and meet the following conditions based on laboratory test results within 7 days before the first dose:1)For those who have not received blood transfusions, blood products or blood cytokines such as granulocyte colony-stimulating factor (G-CSF) within 14 days of the first dose, blood routine: neutrophil count ≥2.0×109/L, platelet count ≥100×109 /L, white blood cell count ≥4.0×109/L, hemoglobin concentration ≥8.0g/dL. 2)Blood biochemistry: liver function: aspartate aminotransferase and alanine aminotransferase ≤1.5 times the upper limit of normal (ULN), total bilirubin ≤ULN. kidney function: creatinine ≤1.5×ULN.
5. Baseline left ventricular ejection fraction determined by echocardiography ≥50%, normal or abnormal 12-lead electrocardiogram without clinical significance, QTc interval \<450ms (men) or \<470ms (women), and no symptoms or signs of heart failure.
6. The functions of major organs (heart, lung, liver, kidney, bone marrow, gastrointestinal) are basically normal or abnormal without clinical significance, and acute toxicity caused by previous treatment is relieved to ≤ grade 1 (except for hair loss).
7. If the subject has been previously treated with surgery, chemotherapy, immunotherapy, biologic therapy, targeted therapy, anti-tumor traditional Chinese medicine, or small molecule targeted drug, the first dose should be given at an interval of 4 weeks or more than 5 half-lives (whichever is shorter)；If the chemotherapeutic agent is mitomycin or nitrosourea, the first dose needs to be given more than 6 weeks apart.
8. The first dose was more than 6 weeks after the last radiotherapy (except palliative radiotherapy for local pain control), and there was no previous whole-pelvic radiotherapy (radiotherapy ≤30% of the bone marrow area).
9. With the consent of the individual and an informed consent form signed by the individual or his legal representative.
10. The subject can communicate well with the researcher and complete the research in accordance with the research regulations.
Exclusion criteria:
1. Those who have received cabazitaxel in the past.
2. Those who are severely allergic to cabazitaxel, human albumin, or alcohol.
3. Currently receiving other anti-tumor therapys.
4. Patients receiving systemic therapy with glucocorticoids (\>10 mg/d prednisone or equivalent dose of steroids) or other immunosuppressants within 14 days before the first dose. In the absence of active autoimmune disease, inhaled or topical glucocorticoids can be used, and hormone replacement therapy doses ≤10 mg/d prednisone equivalent are allowed.
5. Those who need to use strong inhibitors or inducers of CYP3A4 within 14 days of the first dose and during the study.
6. Those with clinically significant mental or central nervous system diseases.
7. Those with active brain metastasis.
8. Those with two or more malignant tumors (except cured non-melanoma skin cancer, cervical cancer, thyroid cancer and gastrointestinal intramucosal cancer)
9. Subjects who have received 2 or more prior treatments with mitomycin or nitrosoureas, or subjects who have received prior intensive therapy with autologous stem cell transplantation.
10. Those with serious medical diseases:1)Existence of clinically important cardiovascular and cerebrovascular diseases, including: severe or uncontrollable heart disease that requires treatment, congestive heart failure rated ≥ grade 3 by the New York Heart Association (NYHA), and unstable angina that cannot be controlled by drugs. A history of myocardial infarction within 6 months before enrollment, and severe arrhythmia requiring drug treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia). 2)Those with indwelling cardiac stent within 6 months.3)Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg), diabetes, pleural effusion, pericardial effusion, and ascites. 4)Uncontrolled peptic ulcer, or other uncontrolled thromboembolic event. 5)Patients with interstitial lung disease, pulmonary fibrosis, or a history of pneumonia who require steroid treatment.
11. People who are infected with HIV, HBV \[those who are positive for hepatitis B surface antigen (HBsAg) and whose HBV-DNA is higher than 1000IU/mL\], HCV ( those who are HCV-Ab positive and whose HCVRNA detection copy number is higher than normal upper limit)and Treponema pallidum.
12. Those with a history of drug abuse.
13. Women who are pregnant or lactating. female patients of childbearing potential who have a positive pregnancy test within 7 days before the first dose. any male and female patients of childbearing potential do not consent to the use of a medically recognized effective method of contraception throughout the trial and for 3 months after final trial drug administration.
14. Those who have participated in other drug clinical trials within 28 days before the first dose.
15. Those who have been vaccinated within 30 days before the first dose or vaccinated during the study period (except for inactivated vaccines).
16. Other circumstances in which the researcher deems it inappropriate to participate in this trial. | 40,008 |
Study Objectives
Background The flaps closure including natal cleft obliteration and eccentric closure are becoming more popular due to their lower rate of recurrence including both the lateral advancement adipo-fascio-cutaneous flap and the classic limberg flap.
Objective This study was aim to compare the results of the surgery for non-complicated pilonidal sinus with the lateral advancement adipo-fascio-cutaneous flap versus the classic Limberg flap.
Patients and methods This study was a prospective randomized controlled, and was conducted on patients with non-complicated pilonidal sinus attending Zagazig University Hospitals, Egypt during the period from February 2017 to August 2019. Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap groups. The follow-up period ranged from 12 to 36 months. Patient satisfaction, complications and recurrence rates were analyzed and compared.
Conditions: Pilonidal Sinus
Intervention / Treatment:
PROCEDURE: lateral advancement flap, PROCEDURE: classic Limberg flap
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* patients with non-complicated pilonidal sinus
* whose ages ranged from 18 to 60years
Exclusion Criteria:
* elderly patients with comorbid diseases
* scars from a previous pilonidal surgery or recurrent cases
* abscess presentations
* diabetes mellitus, immunodeficiency, or other co-morbidity
* American Society of Anesthesiologists physical status classification grade III-IV
* age \< 18years or \> 60 years | 2,437 |
Study Objectives
18F-FDOPA PET-CT is currently the gold standard in the evaluation of Pheochromocytomas and Paragangliomas (PHEO - PGL) since these tumors can also decarboxylate amino acids such as dihydroxyphenylalanine (DOPA). This property is common to tumors of the APUD system (Amine Precursor Uptake and Decarboxylation). In recent years, PET (Positron Emission Tomography) imaging using peptide receptors has gained an increasing role in the management of NETs. The use of somatostatin agonists, radiolabeled with gallium-68 (68Ga) enables targeting of Somatostatin receptors (SSTRs) with a PET resolution. This has improved diagnosis of SSTRs-expressing tumors, including PGLs.
In the present study, the investigators have chosen DOTATATE (Nal3-octreotate) rather than other agonists (DOTATOC and DOTANOC), because of its higher affinity for SST2 which is the most overexpressed subtype in PHEO/PGL. However, performances of 18F-FDOPA PET-CT and 68Ga-DOTATATE PET-CT have never been compared in this clinical setting.
Conditions: Paragangliomas, Pheochromocytomas
Intervention / Treatment:
OTHER: PET-CT
Location: France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
Age ≥ 18
* PHEO or PGL: initial staging or restaging
* Reference imaging within the last 2 months: multiphasic cervico-thoracoabdominal CT scan, 18F-FDOPA PET-CT and head and neck MRI (if head and neck localization
Exclusion Criteria:
Pregnant or breast-feeding woman | 36,139 |
Study Objectives
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine surgery.
Conditions: Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer, Ovarian Cancer, Urothelial Carcinoma, Non-small Cell Lung Cancer
Intervention / Treatment:
DRUG: ONM-100
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Biopsy-confirmed diagnosis of primary or recurrent respective tumor type and scheduled to undergo surgical resection
* Part 1: Biopsy-confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) or breast cancer
* Part 2: Biopsy-confirmed diagnosis of HNSCC, breast cancer, colorectal cancer, prostate cancer, ovarian cancer, urothelial carcinoma and non-small cell lung cancer.
* Part 3: Stage 2 to 4 HNSCC Including T0 or Tx unknown Primary cancers
Exclusion Criteria:
* Histologically diagnosed by an excisional biopsy procedure
* Tumors at sites of which the surgeon would assess that in vivo intraoperative imaging would not be feasible
* Life expectancy \<12 weeks
* Hepatic impairment (Child-Pugh score \>5) or significant liver disease including active hepatitis or cirrhosis | 4,269 |
Study Objectives
This phase I trial will use the combination of irinotecan and BKM120 in patients with advanced colorectal cancer who have failed on or have become intolerant of at least one line of therapy for advanced colorectal cancer and who are candidates for irinotecan therapy.
Conditions: Colorectal Cancer
Intervention / Treatment:
DRUG: Irinotecan, DRUG: BKM120
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 adenocarcinoma of the colon or rectum with measurable disease (patients who have become resistant or intolerant of at least one-line of chemotherapy regimen are eligible)
* Patients who had had previous treatment with Irinotecan and who have definite progression on Irinotecan are eligible provided they are not a candidate for other therapeutic treatment options. Definitive progression is defined as progression of disease while on Irinotecan or within 4 weeks of discontinuing Irinotecan.
* ≥ 18 years old
* ECOG performance status ≤ 2 (Karnofsky \> 60%)
* ANC ≥ 1.5 x 109/L, Platelets ≥ 100 x 109/L, Hb \>9 g/dL
* Serum bilirubin within normal range (or \< 1.5 x IULN if liver metastases present; or total bilirubin ≤ 3.0 x IULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)
* AST (SGOT) or ALT (SGPT) within normal range (or ≤ 3.0 x upper limit of normal if liver metastases present)
* adequate renal function as evidenced by creatinine ≤ 1.5 x IULN or creatinine clearance ≥ 50 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.
* serum calcium (corrected for serum albumin) within normal limits. Biphosphonate use for malignant hypercalcemia control is not allowed.
* Serum magnesium ≥ the institutional lower limit of normal (ILLN) and potassium within institutional normal limits.
* serum lipase ≤ IULN; serum amylase ≤ IULN; fasting plasma glucose ≤ 120 mg/dL (6.7 mmol/L)
* females of child-bearing potential must have negative serum pregnancy test within 72 hours prior to treatment. Cannot be pregnant or nursing.
* Males and females must agree to use effective contraceptive method.
* INR ≤ 2 Exclusion Criteria
* Previous treatment with chemotherapy, biologic therapy, or wide field radiotherapy \< 4 weeks or limited field radiation for palliation \< 2 weeks prior to starting study drug; must have recovered from side effects of such therapy
* Known hypersensitivity to BKM120 or to its excipients or to irinotecan
* Untreated brain metastases. Patients with metastatic CNS tumors may participate in this trial, if the patient is \> 4 weeks from therapy completion, is clinically stable and is not receiving corticosteroid therapy
* Known polymorphism in UGTAIA or Gilbert's syndrome
* Acute or chronic liver, renal disease or pancreatitis
* Medically documented history or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, history of suicidal attempt or ideation, or homicidal ideation; ≥ CTCAE grade 3 anxiety; meets cutoff score of ≥ 10 in the PHQ-9 or cut-off of ≥ 15 in GAD-7 mood scale, respectively, or selects positive response of "1, 2, or 3" to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
* Clinically significant heart disease including: Left ventricular ejection fraction (LVEF) \<50% as determined by echocardiogram; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromised cardiac function; symptomatic pericarditis; QTc \> 480 msec on screening ECG (using QTcF formula; angina pectoris that requires use of anti-anginal medication
* History of cardiac dysfunction including: acute myocardial infarction ≤ 6 months, documented by persistent elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LVEF function; history of documented congestive heart failure (NYHA Class III or IV; document cardiomyopathy
* Other concurrent severe and/or uncontrolled concomitant medical conditions
* Significant symptomatic deterioration of lung function. If clinically indicated, pulmonary function tests including measures of predicted lung volumes, DLco, O2 saturation at rest on room air should be considered to exclude pneumonitis or pulmonary infiltrates
* Clinical manifestation of diabetes mellitus or steroid-induced diabetes mellitus
* Impairment of GI function or disease that may significantly alter the absorption of BKM120; diarrhea ≥ grade 2
* Major surgery ≤ 4 weeks prior to starting study drug
* Prior treatment with a P13K inhibitor; any hematopoietic colony-stimulating growth factors ≤ 2 weeks prior to starting study drug; corticosteroids ≤ 2 weeks prior to starting study drug; chemotherapy or targeted anticancer therapy ≤4 weeks (6 weeks for nitrosourea, antibodies or mitomycin-C) prior to starting study drug; small molecule therapeutics (excluding monoclonal antibodies) ≤5 effective half-lives prior to starting study drug
* Currently receiving medication that has the potential to prolong the QT interval or inducing Torsades de Pointes
* chronic treatment with steroids or another immunosuppressive agent. Note: Topical applications (eg rash), inhaled sprays (eg obstructive airways diseases), eye drops or local injections (eg intra-articular) are allowed. Patients with previously treated brain metastases, who are on stable low dose corticosteroids treatment (eg dexamethasone 2 mg/day, prednisolone 10 mg/day) for at least 14 days before start of study treatment are eligible.
* therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant.
* any medications or substances that are inhibitors or inducers of specific CYP450 enzyme(s).
* any other study agents
* Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug. Herbal medications include, but are not limited to St. John's wort, Kava, ephedra (ma huang), gingko biloba, dehydroepiandrosterone (DHEA), yohimbe, saw palmetto, and ginseng. Fruits include the CYP3A inhibitors Seville oranges, grapefruit, pummelos, or exotic citrus fruits.
* Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
* Women who are pregnant or breast feeding; adults of reproductive potential not using an effective method of birth control.
* Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (eg age appropriate, history of vasomotor symptoms) or 6 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 6 weeks 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.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during treatment for 8 days after stopping treatment and for additional 12 weeks after study drug discontinuation. Highly effective contraception is defined as: true abstinence: Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Sterilization: have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
* Male partner sterilization (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female subjects on the study, the vasectomised male partner should be the sole partner for that patient.
* Use of a combination of any two of the following (a+b): Placement of an intrauterine device (IUD) or intrauterine system (IUS); Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository; Oral contraception, injected or implanted hormonal methods are not allowed as BKM120 potentially decreases the effectiveness of hormonal contraceptives.
* Fertile males must use condom during treatment, for 8 days after stopping treatment and for additional 12 weeks after study drug discontinuation and should not father a child in this period.
* Known diagnosis of human immunodeficiency virus (HIV) infection
* History of another malignancy within 3 years, except cured basal cell skin carcinoma or excised cervical carcinoma in situ
* Previous treatment with Irinotecan who have definite progression on Irinotecan. | 15,375 |
Study Objectives
This research is being done to determine whether exercise while receiving doxorubicin or Adriamycin chemotherapy for breast cancer can reduce the cardio-toxic effects of this treatment on the heart and improve other outcomes related to cancer such as tumor markers, nausea, fatigue and the ability to tolerate chemotherapy.
Conditions: Breast Cancer Female, Adriamycin Toxicity
Intervention / Treatment:
BEHAVIORAL: 10,000 steps, BEHAVIORAL: Usual Care
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* Women who are 18 years and older
* Women newly diagnosed with stage I to III breast cancer who will be receiving adjuvant or neoadjuvant doxorubicin-based chemotherapy
* Women who will be treated at the Johns Hopkins Hospital, Sibley Memorial Hospital or who will be treated by oncologists in the community as long as we will have access to treatment records.
* Women must be willing to receive follow up care either at Hopkins or with their local oncologist for at least 1 year.
* Patients who are receiving therapy with an anthracycline.
* Women who have a smart phone
Exclusion Criteria:
* Inability to exercise
* Presence of metastatic disease
* Advanced pulmonary disease as assessed by clinical symptoms of shortness of breath or known forced expiratory volume in 1 second \< 1
* Any patients requiring oxygen at baseline
* The presence of known ischemic heart disease as defined by significant obstructive heart disease (stenosis \> 70%) seen on coronary angiography or cardiac CT
* Abnormal baseline cardiac function defined as an ejection fraction of less than 55%
* The presence of more than mild valvular stenosis or regurgitation, prosthetic valves or pacemaker on their baseline echocardiogram
* Poor image quality on baseline echocardiogram or anatomic limitations that preclude the acquisition of good quality images such as recent mastectomy or surgery
* Patients who do not have a smart phone onto which the Under Armour application can be downloaded
* Patients who are unwilling to wear the Under Armour health band
* Pregnancy
* Previous anthracycline exposure
* Rhythms other than sinus rhythm
* Patients unwilling to come to the Johns Hopkins campus to have the required testing performed | 9,378 |
Study Objectives
Evaluation of detection rate of 18F-Fluciclovine compared to current standard of care imaging techniques within 30 days of the standard of care imaging study and a 6 month phone follow-up
Conditions: Patients With Prostate Cancer
Intervention / Treatment:
DIAGNOSTIC_TEST: Pelvic CT or MRI + MDP bone scan + or - 18F-NaF PET/CT(SOC)
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. Age \>18 and ≤89
2. History of Prostate Cancer which required surgical resection or radiation
3. Documented Biochemical recurrence defined as a positive PSA any time after the initial diagnosis of prostate cancer which at that time required surgical resection or radiation and then had a negative result to a post treatment PSA.
4. Patient undergoing standard of care work up pelvic CT or MRI, 99mTc-MDP bone scan, and F18 NaF PET/CT.
-
Exclusion Criteria:
1. BCR with negative 99mTc-MDP bone scan but 18F-NaF PET/CT was not able to be done.
- | 32,811 |
Study Objectives
RATIONALE: Transcendental meditation may be an effective way to decrease the amount of stress in older women with breast cancer. It is not yet known if transcendental meditation is more effective than basic breast cancer education in improving quality of life.
PURPOSE: This randomized clinical trialstudies stress reduction in improvingquality of life in older women with stage II, stage III, or stage IV breast cancer.
Conditions: Breast Cancer, Psychosocial Effects of Cancer and Its Treatment
Intervention / Treatment:
PROCEDURE: psychosocial assessment and care, PROCEDURE: quality-of-life assessment
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose:
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Diagnosis of stage II, III, or IV breast cancer
* No brain or CNS metastases
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 55 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* ECOG 0-2
Life expectancy:
* More than 3 months
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* No non-cancer life-threatening illness
* No history of major psychiatric disorders
* No drug abuse dependency disorder
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified | 11,617 |
Study Objectives
The purpose of this study is to find out whether the new drug PX-866 will slow the growth of your prostate cancer. The investigators will also watch you carefully for any side effects that PX-866 might cause.
Conditions: Prostate Cancer
Intervention / Treatment:
DRUG: PX-866
Location: Canada
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 histological or cytological diagnosis of adenocarcinoma of the prostate.
* All patients must have formalin fixed paraffin embedded tissue (from their primary or metastatic tumour) available for translational studies.
* Presence of clinically and/or radiologically documented disease (measureable or non-measurable). All radiology studies must be performed within 28 days prior to registration (within 35 days if negative).
* Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (\< 1.7 nmol/L) must be present.
* Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated.
* No prior chemotherapy regimens for recurrent disease
For Part A, patients must have progression defined as:
PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of ≥ 5 ng/ml and must be performed no longer than 7 days prior to trial registration.
OR Radiological Progression: defined as the development of new metastatic lesions with a stable or rising PSA.
Patients entered to Part B of the study (after 2nd stage of accrual completed) must have a rise in their PSA while on abiraterone/prednisone continuing at time of registration (≥ 25% higher from baseline or nadir, whichever is lowest).
* The PSA must be ≥5 ng/ml at the time of study entry.
* ECOG performance of 0, 1 or 2.
* Age ≥ 18 years of age.
Previous therapy:
Surgery:
Previous major surgery is permitted provided that it has been at least 14 days prior to patient registration and that wound healing has occurred.
Hormonal Therapy:
Prior hormone therapy is required. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide). Therapy with LHRH agonist must continue for those prostate cancer patients already receiving this treatment at the time of enrollment. If the patient has discontinued the LHRH agonist, this must be restarted (if not surgically castrated) and the castrate level of testosterone must be present. Prior therapy with CYP17 inhibitors (e.g. abiraterone, ketoconazole) or novel anti-androgens (e.g. MDV3100) is permitted.
Part B: Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry (at least 6 weeks for bicalutamide). Therapy with LHRH agonist must continue for those prostate cancer patients already receiving this treatment at the time of enrollment. If the patient has discontinued the LHRH agonist, this must be restarted (if not surgically castrated) and the castrate level of testosterone must be present. All patients must currently be receiving abiraterone.
Radiation:
Prior external beam radiation is permitted provided a minimum of 2 weeks has elapsed between the last dose and enrollment to the trial. Exceptions may be made for low dose, non-myelosuppressive radiotherapy after consultation with NCIC CTG. Prior strontium is not permitted.
- Laboratory Requirements (must be done within 7 days prior to registration)
Hematology:
Granulocytes (AGC) ≥ 1.5 x 10\^9/L Platelets ≥ 100 x 10\^9/L
Biochemistry:
Serum creatinine ≤ 1.5 x UNL Total bilirubin ≤ 1.5 x UNL ALT and AST ≤ 1.5 x UNL Glucose ≤ 8.9 mmol/L (≤ Grade 1) PSA ≥ 5ng/mL
-Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrollment in the trial to document their willingness to participate.
Patients who cannot give informed consent (i.e. mentally incompetent patients, or those physically incapacitated such as comatose patients) are not to be recruited into the study. Patients competent but physically unable to sign the consent form may have the document signed by their nearest relative or legal guardian. Each patient will be provided with a full explanation of the study before consent is requested.
* Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre. This implies there must be reasonable geographical limits (for example: 2 hour's driving distance) placed on patients being considered for this trial. Investigators must assure themselves that the patients registered on this trial will be available for complete documentation of the treatment, adverse events, response assessment and follow-up.
* In accordance with NCIC CTG policy, protocol treatment is to begin within 5 working days of patient registration.
Exclusion Criteria:
* Patients with a history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumours curatively treated with no evidence of disease for \>=3 years.
* Known HIV-positive patients.
* Uncontrolled diabetes mellitus.
* Patients with upper gastrointestinal or other conditions that would preclude compliance or absorption of oral medication are not eligible.
* Patients with active or uncontrolled infections, or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
* Patients are not eligible if they have a known hypersensitivity to the study drug(s) or their components.
* Patients with history of central nervous system metastases or untreated spinal cord compression.
* Patients who have had prior treatment with a PI3 kinase inhibitor.
* Men who are not sterile unless they use an adequate method of birth control.
* Patients enrolled to Part B must be suitable for continued therapy with abiraterone/prednisone. | 37,240 |
Study Objectives
This is a pilot study that will be an exploratory investigation of the rate of occurrence of ADHD/S-ADHD in adolescent cancer survivors. The procedures that will be used for identifying attention problem symptoms, determining the frequency and severity of such symptoms, and characterizing the level of impairment resulting from the symptoms are novel to pediatric oncology research.This pilot study will draw from the approach used in traumatic brain injury research of post-injury effects to illuminate more clearly the nature of attentional late effects experienced by survivors of childhood cancer.
Conditions: ADHD, Cancer
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
1. Patients treated for acute lymphoblastic leukemia (ALL) OR primary central nervous system (CNS) tumor.
2. Completed primary treatment at least one year prior to enrollment with no evidence of active disease.
3. Age 12-17 years inclusive at the time of enrollment.
4. At least one parent/guardian must be present.
5. Participant and parent are able to understand English.
6. Participant and parent are willing and able to provide consent/assent according to institutional guidelines.
7. Parent/guardian signs consent.
Exclusion Criteria:
1.Significant impairment in intellectual functioning (e.g., full or estimated IQ \<70) as documented in the medical record. | 41,570 |
Study Objectives
The study is intended as a Proof of Concept and dose confirmation study. The primary objective of this study is to observe safety and tolerability of idronoxil (NOX66) in combination with radiotherapy (at palliative doses) in patients with metastatic castrate-resistant prostate cancer (CRPC) and to confirm dose in order to progress to Phase 2/3.
Conditions: Cancer
Intervention / Treatment:
DRUG: NOX66, RADIATION: Irradiation Therapy
Location: Australia, Georgia, New Zealand
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. Provision of informed consent
2. ≥ 18 years of age
3. Histologically confirmed prostate cancer and/or PSA of \>100 ng/mL at original diagnosis
4. Metastatic disease evidenced by either CT/MRI imaging or bone scan
5. Objective evidence of disease progression as defined by either:
i. Radiographic progression of in nodal or visceral metastases and bone disease progression with 2 or more new lesions ii. Rising PSA value ≥2ng/ml in at least 3 measurements, at least 1 week apart, with castrate levels of serum testosterone.
6. Eligible to receive palliative radiation therapy for management of disease
7. At least one symptomatic lesion which is suitable for radiation therapy
8. ECOG Performance status 0-2
9. A minimum life expectancy of 24 weeks
10. Adequate bone marrow, hepatic and renal function as evidenced by:
* Absolute neutrophil count (ANC) \> 1.5 x 109/L
* Platelet count \> 100 x 109/L
* Hemoglobin \> 9.0 g/dL
* Serum bilirubin \< 1.5 x ULN
* AST/ALT (SGOT/SGPT) \< 2.5 x ULN for the reference laboratory or \< 5 x ULN in the presence of liver metastases
* Serum creatinine \< 1.5 x ULN
11. Ongoing androgen deprivation therapy with luteinizing hormone-releasing hormone (LHRH) agonist or antagonist
12. At least 4 weeks must have elapsed prior to commencement of NOX66 treatment since prior chemotherapy, investigational drug or biologic therapy and any toxicity associated with these treatments has recovered to ≤ NCI-CTCAE (version 4.03) Grade 1.
13. At least 21 days must have elapsed following major surgery and any surgical incision should be completely healed.
Exclusion Criteria:
1. Tumour involvement of the central nervous system
2. Uncontrolled infection or systemic disease
3. Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease, angina, and cardiac arrhythmias) or myocardial infarction within the last 12 months
• Patients with a QTc \> 470 msec on screening ECG
4. Concurrent systemic chemotherapy or biological therapy
5. Any situation where the use of suppository therapy is contra-indicated or impractical (eg. chronic diarrhoea, colostomy, ulcerative colitis).
6. Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
7. Any subject whose testosterone is not suppressed i.e. is \> 0.5nmols/L
8. Any other reason which, in the opinion of the investigator, will preclude suitable participation in the study. | 19,378 |
Study Objectives
To determine whether further study of single-agent enzastaurin is warranted in patients with previously treated Waldenstrom's Macroglobulinemia or Multiple Myeloma based on response.
Conditions: Waldenstrom's Macroglobulinemia, Multiple Myeloma
Intervention / Treatment:
DRUG: Enzastaurin
Location: United States, France
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* At least 18 years of age.
* Patients must have Waldenstrom's Macroglobulinemia (WM) or Multiple Myeloma (MM) previously treated with at least 1 and no more than 5 prior therapies.
* Treatment with prior autologous transplant is permitted. If a transplant is used as consolidation following chemotherapy, without intervening disease progression, it will be considered 1 line of treatment with the preceding chemotherapy.
* Patients with MM must have a monoclonal protein in the serum of greater than or equal to 1 gram per deciliter (g/dL) or monoclonal light chain in the urine protein electrophoresis of greater than or equal to 200 milligrams (mg)/ 24 hours, or measurable plasmacytoma.
* Patients with WM must have an immunoglobulin M (IgM) paraprotein with a minimum IgM level of \> 2 times the upper limit of normal (ULN), have detectable lymphoplasmacytic (LPL) cells in the bone marrow, and be symptomatic for WM.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2.
* The following laboratory values obtained prior to registration:
* Absolute neutrophil count (ANC) greater than or equal to 1000/microliter
* Platelet (PLT) count greater than or equal to 75,000/microliter
* Total bilirubin less than or equal to 1.5 x ULN (if total is elevated check direct and, if normal, patient is eligible)
* Aspartate transaminase (AST) less than or equal to 3 x ULN
* Creatinine less than or equal to 1.5 x ULN
* Hemoglobin (Hgb) greater than or equal to 8.0 g/dL.
* Expected survival of greater than 12 weeks.
* The ability to provide informed consent.
* Male and female patients with reproductive potential must use an approved contraceptive method, if appropriate (for example, intrauterine device \[IUD\], birth control pills, or barrier device) during and for 3 months after discontinuation of study treatment. Women with childbearing potential must have a negative serum pregnancy test less than or equal to 3 days prior to study enrollment
Exclusion Criteria:
* Prior allogeneic hematopoietic stem cell transplant.
* Are unable to discontinue use of non-Enzyme-Inducing Anti-Epileptic Drugs (EIAEDs), for example carbamazepine, phenobarbital, and phenytoin. Patients on anti-coagulant therapy should be monitored. Ongoing treatment with therapeutic doses of Coumadin is prohibited. However, prophylactic, low dose (less than or equal to 2 mg daily) Coumadin for deep venous thrombosis (DVT) is allowed. In such cases, prothrombin time/ international normalized ratio (PT/INR) should be closely monitored.
* Have electrocardiogram (ECG) abnormalities including baseline 12-lead ECG with QTc interval of greater than 450 milliseconds (msec) in males or greater than 470 msec in females, or QRS duration of greater than 100 msec. Patients who have a congenital long-QT-syndrome in their own or family medical history should be excluded at the investigator's discretion.
* Have an uncontrolled infection.
* Have prior treatment with Carmustine (BCNU) 6 weeks, alkylating agent 4 weeks, or other cytotoxic chemotherapy agents 4 weeks prior to registration in this trial. Have prior treatment with biologic therapy less than or equal to 12 weeks or corticosteroids less than or equal to 2 weeks prior to registration in this trial. However, treatment with less than or equal to 10 mg of prednisone as a chronic therapy is allowed.
* Have radiation therapy less than or equal to 2 weeks prior to treatment in this trial.
* Are pregnant or breast-feeding.
* Are being treated with concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational.
* Are known to be human immunodeficiency virus (HIV) positive.
* Were previously treated with enzastaurin.
* Patients who are unable to swallow tablets.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
* Concurrent malignancy that could complicate interpretation of response or safety evaluation. Non-melanoma skin cancer and carcinoma in situ of the cervix are not exclusions. | 1,434 |
Study Objectives
We aim to determine the effectiveness of 2013 "Mag paDRE ka" programme in increasing general public awareness on prostate health and promoting prostate health assessment among Filipino males aged 40 or older.
Conditions: Benign Prostatic Hyperplasia, Prostatitis, Prostate Cancer
Intervention / Treatment:
OTHER: Prostate health screening
Location: Philippines
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Filipino male ages 40 or older consulted on "Pa-DRE ka" prostate health screening program 2013
* patients presented to the Philippine Board of Urology accredited 11 training institutions
* Consented for the screening program.
* Completed the questionnaire of International Prostate symptoms score
* Has been examined with digital rectal examination
Exclusion Criteria:
* Patients who have incomplete data and did not consent for the screening program
* Non-Filipino male patients | 37,987 |
Study Objectives
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer chemotherapy.
Conditions: Hepatitis C Virus Infection
Intervention / Treatment:
DRUG: LDV/SOF
Location: Egypt
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Key Inclusion Criteria:
* Aged 12 to \<18 years
* Parent or legal guardian must provide written informed consent
* Treatment naïve or experienced children with genotype 1 or 4 HCV infection, and are on a maintenance cancer chemotherapy regimen
* Receiving a protocol-approved maintenance chemotherapy regimen for a hematological malignancy
* Chronic HCV infection (≥ 6 months) documented by medical history or liver biopsy
* Screening laboratory values within defined thresholds
* No History of solid organ or bone marrow transplantation
* No history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply. | 33,149 |
Study Objectives
The I-START trial is designed to determine the highest doses of radiotherapy that can safely be used in locally advanced non-small cell lung cancer (NSCLC). Patients with NSCLC who are expected to live longer than three months and are fit to receive radical radiotherapy (radiotherapy given with curative intent) will be eligible to participate. All trial participants will receive 20 doses (called fractions) of radiotherapy. Evidence is available that suggests increasing the dose of radiotherapy given per fraction may improve both local control of the cancer and survival in some patients. However, high dose radiotherapy can damage normal tissues as well as the tumour. The dose of radiotherapy that can be used to treat lung cancer is limited by the normal tissues close to the cancer. For most of these normal tissues (lung, spinal cord and heart) the maximum safe radiotherapy dose that can be given is known. The maximum safe dose of radiotherapy for the oesophagus (gullet) is not currently known.
The trial will be split into two parts:
1. For those participants where the oesophagus will receive a high dose of radiation due to it lying close to the cancer, the first part of the trial will establish the maximum safe dose of radiotherapy to the oesophagus. The first group of participants will receive a slightly higher dose than is currently used to treat lung cancer. If these participants do not have any significant side effects, a second group of participants will receive a slightly higher dose than the first group. This process will continue incrementally until side effects from the treatment become evident, thus demonstrating the maximum dose that can safely be given. Once the maximum safe dose to the oesophagus is known this will be classed as the recommended Phase II dose and all further patients entering the trial will receive no more than this dose to the oesophagus.
2. For those participants where the cancer is a safe distance from their oesophagus, the highest dose of radiotherapy that does not exceed the known safe dose limits of the normal structures (lung, spinal cord and heart) will be used.
The findings of both parts of this study will determine whether increasing the dose of radiotherapy for NSCLC patients is a tolerable, safe and effective treatment. If the results are positive then this new treatment may be compared against the best currently available standard treatments in a future larger randomised (Phase III) trial.
Conditions: Locally Advanced Non-small Cell Lung Cancer
Intervention / Treatment:
RADIATION: Radiotherapy
Location: United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. Histologically or cytologically confirmed stage II - IIIb NSCLC (see appendix II)
2. Inoperable disease (as assessed by a lung cancer MDT with thoracic surgical input) or operable but the patient refuses surgery
3. Disease which can be encompassed within a radical radiotherapy treatment plan in keeping with standard practice at the participating centre
4. WHO Performance Status 0 or 1 (Appendix III)
5. Adequate respiratory function: FEV1 ≥ 1.0 litre, DLco (transfer factor) ≥ 40% of predicted and Kco (DLco/VA) \> 40% predicted on baseline lung function tests
6. Blood Haemoglobin ≥ 10g/dL
7. No prior thoracic radiotherapy
8. Age ≥ 16 years
9. Considered fit to receive trial treatment
10. Estimated life expectancy of more than 3 months
11. Written informed consent obtained
12. Patient consents for electronic CT scan and planning data to be used for future research
13. Patient is available for follow up
Exclusion Criteria:
1. Medically unstable (e.g. unstable diabetes, uncontrolled hypertension, infection, hypercalcaemia or very symptomatic ischaemic heart disease)
2. Previous or current malignant disease likely to interfere with protocol treatment
3. Pancoast tumours
4. Connective tissue disorders (e.g. Scleroderma, Systemic Lupus Erythematosus)
5. Interstitial lung disease
6. Women who are pregnant or lactating
7. Women of childbearing potential who are not using adequate contraceptive precautions | 4,404 |
Study Objectives
The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets for vaccination against lung cancer. In this clinical study, the investigators examine using a combination of these three peptides the safety, immunogenicity, and antitumor effect of vaccine treatment to prevent relapse of the disease for HLA-A\*2402-positive advanced non-small cell lung cancer patients whose disease are controlled after any standard therapies.
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
BIOLOGICAL: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant
Location: Japan
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
1. NSCLC whose disease are controlled after any standard therapies, but who do not have any additional standard ones to prevent .future relapse of the disease.
2. ECOG performance status 0-2
3. Age between 20 to 85
4. Clinical efficacy can be evaluated by some methods
5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within appropriate periods
6. Life expectancy \> 3 months
7. Laboratory values as follows 1500/mm3 \< WBC \< 15000/mm3 Platelet count \> 75000/mm3 Asparate transaminase \< 3 X cutoff value Alanine transaminase \< 3 X cutoff value Total bilirubin \< 3 X cutoff value Serum creatinine \< 2X cutoff value
8. HLA-A\*2402
9. Able and willing to give valid written informed consent
Exclusion Criteria:
1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)
2. Myocardial infarction within six months before entry
3. Breastfeeding and Pregnancy (woman of child bearing potential)
4. Active and uncontrolled infectious disease
5. Concurrent treatment with steroids or immunosuppressing agent
6. Other malignancy requiring treatment
7. Non-cured traumatic wound
8. Decision of unsuitableness by principal investigator or physician-in-charge | 44,489 |
Study Objectives
This study will assess the safety, tolerability, and efficacy of every-3-week dosing (Q3W) of pembrolizumab (MK-3475) in participants with advanced melanoma; participants may receive pembrolizumab for up to 2 years if deriving clinical benefit. The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.
Conditions: Melanoma
Intervention / Treatment:
BIOLOGICAL: Pembrolizumab
Location:
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria:
* Histologically confirmed diagnosis of locally advanced (unresectable Stage III) or metastatic (Stage IV) melanoma not amenable to local therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* At least one measurable lesion
* Adequate organ function
Exclusion criteria:
* Prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-PD ligand-1 (PD-L1), anti-PD-L2, anti-CD137 antibody, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) agent
* Is currently participating or has participated in a study with an investigational compound or device within 30 days, or 5X half-life of the investigational compound, whichever is longer, of initial dosing on this study
* Chemotherapy, targeted small molecule therapy, radiotherapy, or biological cancer therapy (including monoclonal antibodies) within 4 weeks prior to the first dose of trial treatment, or not recovered (\<= Grade 1 or baseline) from adverse events due to a previously administered agent
* Expected to require any other form of systemic or localized antineoplastic therapy while in study
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents
* Receiving systemic steroid therapy or any other form of immunosuppressive therapy within 1 week prior to the first dose of study treatment
* Received a live vaccine within 4 weeks prior to the first dose of trial treatment
* Has a known hypersensitivity to the components of the study drug or another monoclonal antibody
* History or evidence of active pneumonitis
* Human immunodeficiency virus (HIV)-positive
* Has known history of active Hepatitis B or C
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial treatment through 120 days after the last dose of study medication | 40,956 |
Study Objectives
This is a randomized phase II open label study of daratumumab, weekly low-dose oral cyclophosphamide and dexamethasone with or without pomalidomide in patients with relapsed and refractory multiple myeloma. The study consists of two arms. Patients will be randomized into ARM A and ARM B in a 1:1 ratio.
Conditions: Multiple Myeloma
Intervention / Treatment:
BIOLOGICAL: DCdP, BIOLOGICAL: DCd+P
Location: Canada
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria - Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
1. Males or females, age 18 years or older.
2. ECOG performance status score of 0, 1 or 2.
3. Life expectancy of at least 3 months.
4. Measurable disease according to the IMWG criteria defined below. (These baseline laboratory studies for determining eligibility must be obtained during the screening period within 28 days prior to start of study drug):
1. Serum monoclonal paraprotein (M-protein) ≥ 10 g/L (if IgG) or ≥5g/L (if IgA, D, E or M)
2. Urine M-protein ≥ 200 mg/24 h
3. Serum free light chains (FLC) assay: Involved FLC level ≥ 100 mg/L and an abnormal serum free light chain ratio (\< 0.26 or \> 1.65).
5. Relapsed or relapsed and refractory disease defined as documented disease progression during or after completing their last treatment line and it must have contained either a proteasome inhibitor and/or lenalidomide. The only exception for non-refractory patients is when re-treatment with these agents is medically contra-indicated.
6. Have undergone at least 1 prior line of therapy. Induction therapy followed by ASCT and consolidation/maintenance will be considered as one line.
7. Have achieved at least a Minimal Response (MR) or better to at least one previous line of therapy, as per IMWG response criteria.
8. Have received at least 2 consecutive cycles of prior treatment that have included lenalidomide or a proteasome inhibitor, either alone or in combination regimens, unless intolerant to these agents.
9. Subjects must be eligible for pomalidomide reimbursement by their provincial jurisdictions or by the criteria of their insurance companies.
10. The following laboratory results must be met within 10 days of first study drug adminitration:
1. ANC ≥ 1.0 x 109/L
2. Hemoglobin ≥ 80 g/L
3. Platelets ≥ 70 x 109/L (or ≥50 x 109/L if ≥50% plasmacytosis in bone marrow.
4. Calculated or measured CrCl ≥ 30 mL/min
5. AST and ALT ≤ 3.0 x ULN
6. Total bilirubin ≤ 2 x ULN unless known to have Gilbert's disease
7. Corrected serum calcium ≤ 3.5 mmol/L
11. Have signed the informed consent documents indicating that the subject understands the purpose of and procedures required for the study and is willing to participate and adhere to the study protocol.
12. Females with child-bearing potential (FCBP†) must agree to use 2 reliable forms of contraception\* simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including during dose interruptions), and for at least 90 days after study treatment discontinuation.
†Females of childbearing potential (FCBP): a female of childbearing potential is a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months).
\* The two methods of birth control used may be selected from the following categories, but the two methods cannot be selected from any one category: barrier method: i.e., condom (male or female) or diaphragm with spermicide; hormonal: i.e., contraceptive pill, patch; intrauterine device (IUD); vasectomy; or tubal ligation.
13. Females must agree to abstain from breastfeeding during study participation and 90 days after study drug discontinuation.
14. Males must agree to use a latex condom during any sexual contact with FCBP while participating in the study and for 90 days following discontinuation from this study, even if he has undergone a successful vasectomy.
15. Males must also agree to refrain from donating semen or sperm during the treatment phase and for 90 days after discontinuation from this study treatment.
16. All subjects must agree to refrain from donating blood while on study therapy and for 28 days after discontinuation from this study treatment.
17. All subjects must be eligible for enrollment and enrolled in the RevAid® program (refer to https://www.revaid.ca/revaid/ for RevAid eligibility).
Exclusion Criteria - Subjects who meet any of the following exclusion criteria are not eligible for enrollment:
1. Prior exposure to daratumumab (or other anti-CD38 monoclonal antibody) or pomalidomide.
2. History of prior allogeneic stem cell transplantation and showing evidence of active graft-versus-host disease or graft-versus-host disease that requires immunosuppressive therapy.
3. Chemotherapy or other anti-myeloma therapy within 14 days prior to the first dose of study drug.
4. Treatment-related toxicity that has not recovered ≤Grade 1 unless deemed to be irreversible (an example of an irreversible toxicity would include steroid induced cataracts). Peripheral neuropathy \> Grade 2 or Grade 2 with pain will be excluded.
5. Subjects who have received steroids within 2 weeks prior to starting study treatment or who have not recovered from side effects of such therapy. Concomitant therapy medications that include corticosteroids are allowed if subject receive ≤ 10 mg of prednisone per day, or equivalent, as indicated for other medical conditions, or up to 100 mg of hydrocortisone as pre-medication for administration of certain medications or blood products prior to enrollment in this study.
6. Subjects who have received any investigational agents within 28 days or 5 half-lives (whichever is shorter, however the minimum allowed timeframe is 14 days) of the first dose (Cycle 1, Day 1).
7. Prior history of malignancies, other than MM, unless the subject has been free of the disease for 3 years or longer. Exceptions include the following:
1. Basal or squamous cell carcinoma of the skin,
2. Carcinoma in situ of the cervix or breast,
3. Adenocarcinoma of the prostate (TNM stage of T1a or T1b).
8. Other concurrent severe and/or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection, acute diffuse pulmonary disease, pericardial disease, uncontrolled thyroid dysfunction) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol.
9. Known chronic obstructive pulmonary disease (COPD), defined as a FEV1 \<50% predicted.
10. Known moderate or severe persistent asthma within the last 2 years, or currently has uncontrolled asthma of any classification.
11. History of or current uncontrolled cardiovascular disease including:
1. Unstable angina, myocardial infarction, or known congestive heart failure Class III/IV (Appendix 5) within the preceding 12 months.
2. Transient ischemic attack within the preceding 3 months, pulmonary embolism within the preceding 2 months.
3. Any of the following: sustained ventricular tachycardia, ventricular fibrillation, Torsades de Pointes, cardiac arrest, Mobitz II second degree heart block or third degree heart block; known presence of dilated, hypertrophic, or restrictive cardiomyopathy.
4. QTc prolongation as confirmed by ECG assessment at screening (QTc \>470 milliseconds).
12. Women who are pregnant, breastfeeding or planning to become pregnant while enrolled in this study, or within 90 days after the last dose of study medications. Male subject who plans to father a child while enrolled in this study, within 90 days after the last dose of study medications.
13. Subjects who are:
1. Known to be seropositive for human immunodeficiency virus (HIV).
2. Seropositive for hepatits B (defined by a positive test for hepatitis B surface antigen \[HBsAg\]). Subjects with resolved infection (ie, subjects who are HBsAg negative but positive for antibodies to hepatitis B core antigen \[anti-HBc\] and/or antibodies to hepatitis B surface antigen \[anti-HBs\]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) DNA levels. Those who are PCR positive will be excluded. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (anti-HBs positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR.
3. Seropositive for hepatitis C (except in the setting of a sustained virologic response \[SVR\], defined as aviremia at least 12 weeks after completion of antiviral therapy).
14. Known allergies, hypersensitivity to mannitol, corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to the Daratumumab PM), or known sensitivity to mammalian-derived products.
15. Known CNS involvement, amyloidosis, or currently active plasma cell leukemia.
16. Subjects who are receiving any other investigational agent.
17. Autologous, peripheral stem cell transplant within 12 weeks of the first dose of study drug
18. Any other condition that, in the Investigator's opinion, would contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures. | 34,494 |
Study Objectives
The purpose of the study is to assess the safety, tolerability and pharmacokinetics of AZD8055 and determine the maximum tolerated dose to take into phase II trials.
Conditions: Solid Tumors
Intervention / Treatment:
DRUG: AZD8055
Location: United States, France, United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histological or cytological confirmation of an advanced solid malignant tumour (or lymphoma Part A only)
* Cancer which is refractory to standard therapies or for which no standard therapy exists, patients with measurable or non-measurable disease (according to RECIST criteria) can be recruited to Part A
* Evidence of post-menopausal status or negative urine/serum pregnancy test for pre-menopausal female patients
Exclusion Criteria:
* Patients with severe laboratory abnormalities for haematology, liver or renal function. Also treatment with any haemopoietic growth factors are not allowed within two weeks from first dose of study drug.
* Patients with abnormal fasting glucose, have type I or II Diabetes or have uncontrolled blood fats and cholesterol
* Patients with a history of neurological disease, peripheral or central neuropathy, brain metastases or family history of myopathy are excluded
* Patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions | 26,085 |
Study Objectives
Water exchange method has been shown to reduce medication requirement and pain experienced during colonoscopy. It may increase the adenoma detection rate (ADR). Water exchange provides salvage cleansing and the refractive index of water (n equals about 1.3) is larger than that of air, which creates optical distortion that likely contributes to objects appearing larger underwater, making smaller lesions easier to visualize and it may help draw attention to those smaller lesions during withdraw. These principles facilitate to the higher adenoma detection rate.
There is a large number of literature on the adenoma detection rate during water exchange colonoscopy, but most studies have been conducted in only one centre, simple-size, and under sedation patients, the influence of adenoma detection rate under unsedation patients was unclear.
The aim of this study is to compare the ADR of colonoscopy by using the water exchange method versus the conventional air method in unsedation patients in multiple centers in China.
Conditions: Adenoma, Pain
Intervention / Treatment:
OTHER: Water colonoscopy
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: SINGLE | Inclusion Criteria:
* age 18-80 patients with intact colon and rectum
Exclusion Criteria:
* prior finding of severe colorectal stricture;
* solid fetus contained in the last stool before colonoscopy
* no bowel preparation or cleansed by enema/lavage
* without the requirement of reaching cecum
* known colorectal polyps or polyposis syndrome without complete removal previously
* pregnant women
* hemodynamically unstable
* patients who cannot give informed consent | 23,679 |
Study Objectives
The interest of pulmonary rehabilitation for patients who underwent lung resection for cancer remains controversial. The investigators studied the effects of the RR and its impact on quality of life and level of anxiety and depression in patients.
In 2011 and 2012 , an RR was proposed to the patients referred to our center after lung resection for cancer. Patients were assessed at entry and departure by 6minutes walk test , a visual analog pain scale , a quality of life questionnaire ( EORTC QLQ C30 ) and an anxiety questionnaire and Depression (HAD) . These same questionnaires were mailed 6 months after the end of the pulmonary rehabilitation .
Conditions: Pulmonary Resection
Intervention / Treatment:
OTHER: questionnaires
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Patient with pulmonary resection
* Patients undergoing a standardized approach (or thoratomie videothoracoscopy) | 3,483 |
Study Objectives
The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
Conditions: Oral Mucositis
Intervention / Treatment:
DRUG: GC4419 90mg, DRUG: Placebo
Location: Canada, United States, Puerto Rico
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE3
Primary Purpose: SUPPORTIVE_CARE
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* squamous cell carcinoma of the head and neck
* treatment plan to receive IMRT delivered as single daily fractions of 2.0 to 2.2 Gy with a cumulative radiation dose of 60-72 Gy
* Treatment plan to receive standard cisplatin monotherapy
* Age 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Adequate hematologic, renal and liver function
* Negative serum pregnancy test
* Use of effective contraception
Exclusion Criteria:
* Tumor of the lips, larynx, hypopharynx, nasopharynx, sinuses, or salivary glands
* Metastatic disease
* Prior radiotherapy to the region of the study cancer or adjacent anatomical
* Prior induction chemotherapy
* Receiving any approved or investigational anti-cancer agent other than those provided for in this study
* Concurrent participation in another interventional clinical study
* Inability to eat soft solid food at baseline
* Malignant tumors other than HNC within the last 5 years
* Active infectious disease excluding oral candidiasis
* Presence of oral mucositis at baseline
* Known history of HIV or active hepatitis B/C
* Female patients who are pregnant or breastfeeding
* Known allergies or intolerance to cisplatin and similar platinum-containing compounds
* Requirement for concurrent treatment with nitrates or other drugs that may create a risk for a precipitous decrease in blood pressure | 11,195 |
Study Objectives
Factors which delay recovery following uncomplicated abdominal surgery include uncontrolled pain, intolerance of diet and poor mobility. Enhanced recovery after Surgery (ERAS) programmes are perioperative care pathways that address systematically these issues (i.e. improved dynamic pain relief, optimised nutritional care and enforced mobilisation) to promote a faster recovery and a shorter stay. The key treatments that improve outcome within an ERAS programme are not known. Moreover there are few acceptable, objective endpoints to assess key outcome variables such as return of GI function. This randomised trial will assess the potential synergy between early recovery of GI function (laxation) and early postoperative oral nutritional support(with associated preoperative preconditioning using carbohydrate/fluid loading). The main overall outcome targets being improved recovery of gastrointestinal function, postoperative nutritional status and physical function. It will validate the use of a novel, objective technique to measure gastric motility (surrogate for GI function). Such refinement of ERAS should result in shorter hospital stay and better use of limited health care resource.
Conditions: Colorectal Liver Metastases
Intervention / Treatment:
DRUG: Post operative laxation (Magnesium Oxide), DIETARY_SUPPLEMENT: Preoperative metabolic conditioning postoperative nutritional supplementation, OTHER: Standard ERAS group
Location: Netherlands, United Kingdom
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: HEALTH_SERVICES_RESEARCH
Allocation: RANDOMIZED
Interventional Model: FACTORIAL
Masking: NONE | Inclusion Criteria:
* Patients undergoing hepatic resection for benign or malignant conditions
* Able to understand the nature of the study and what will be required of them.
* Men and non-pregnant, non-lactating women
* BMI 18 - 30
Exclusion Criteria:
* Inability to give written, informed consent
* Patients with dementia or neurological impairment
* Patients with pre-existing condition limiting mobility
* Planned bile duct excision
* Repeat or staged procedures
* Central extended resections
* Underlying cirrhotic liver disease
* Jaundice (Bilirubin \> 50 μmol/L) | 37,642 |
Study Objectives
To study the efficacy of everolimus combined with temozolomide as first-line treatment in advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as disease control rate (non-progressive disease) at 6 months.
Conditions: Neuroendocrine Carcinoma
Intervention / Treatment:
DRUG: Everolimus , temozolomide
Location: Norway
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria
Histologically proven neuroendocrine carcinoma with a Ki67 of 20-55%.Primary gastroenteropancreatic tumor or cancer of unknown primary where metastases are mainly abdominalMeasurable disease according to RECIST by CT/MR
General conditions:
* \>18 years;
* WHO/ECOG performance status 0-1.
* Adequate haematological, renal and hepatic functions:
* Written informed consent prior to inclusion
Prior therapy:
* No prior chemotherapy treatment for advanced disease.
* Adjuvant chemotherapy must have ended \> 6 months before inclusion.
Prior or current history:
* No curatively resectable disease;
* No other serious illness or medical conditions (including: unstable angina, myocardial infarction within 6 months, unstable diabetes, immune suppression )
Concomitant treatments :
* No concomitant (or within 4 weeks before inclusion) administration of any other experimental drug;
* No other concurrent anti-cancer therapy.
Other :
* Not pregnant or breast feeding. Fertile patients must use adequate contraceptives and fertile females must have a negative pregnancy test. | 11,368 |
Study Objectives
This study is being done to evaluate the safety and efficacy of pembrolizumab (MK-3475) in participants with advanced non-small cell lung cancer (NSCLC) tumors that are positive for programmed cell death ligand 1 (PD-L1): the hypothesis is that treatment with pembrolizumab will result in a clinically meaningful Overall Response Rate (ORR).
Conditions: Non-small Cell Lung Cancer
Intervention / Treatment:
BIOLOGICAL: Pembrolizumab
Location:
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 diagnosis of non-small cell lung cancer (NSCLC) that is PD-L1 positive per central laboratory review
* At least one measurable lesion
* Radiographic progression of NSCLC after treatment with a platinum-containing doublet for Stage IIIB/IV or recurrent disease
* Eastern Cooperative Oncology Group (ECOG) Performance Scale 0 or 1
* Adequate organ function
Exclusion Criteria:
* Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 3 weeks of the first dose of trial treatment
* Systemic steroid therapy within 3 days prior to the first dose of trial treatment or any other form of immunosuppressive medication
* Expected to require any other form of systemic or localized antineoplastic therapy while on trial
* History of prior malignancy, with the exception of basal cell carcinoma of the skin, superficial bladder cancer, squamous cell carcinoma of the skin, or in situ cancer
* Active central nervous system (CNS) metastases and/or carcinomatous meningitis
* Active autoimmune disease or documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents
* Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody
* Concurrent or past history of interstitial lung disease
* Pregnant or breast-feeding, or expecting to conceive or father children within the projected duration of the study, starting with screening visit through 120 days after the last dose of pembrolizumab | 33,275 |
Study Objectives
This pilot clinical trial studies tumor-specific markers (clonotype), blood tests, and positron emission tomography (PET)/computed tomography (CT) in predicting treatment response at different times during chemotherapy in patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Studying samples of blood in the laboratory from patients during chemotherapy may help doctors learn more about the effects of treatment on cells and may help doctors determine whether patients are responding to treatment. PET/CT scan procedures are done at the same time with the same machine and the combined scans give more detailed pictures of areas inside the body than either scan gives by itself and may help doctors find out how well treatment is working.
Conditions: Recurrent Diffuse Large B-Cell Lymphoma, Refractory Diffuse Large B-Cell Lymphoma
Intervention / Treatment:
DRUG: Chemotherapy, PROCEDURE: Computed Tomography, DRUG: Fludeoxyglucose F-18, PROCEDURE: Positron Emission Tomography
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose: DIAGNOSTIC
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Subject/legal representative willing and able to provide written informed consent
* Histologically confirmed aggressive B-cell DLBCL, including follicular lymphoma (FL) transforming to DLBCL and high grade B-cell lymphoma
* Willing to provide existing relapse-confirmatory DLBCL tumor sample
* Relapsed from or refractory to at least one treatment containing a CD20 monoclonal antibody combined with anthracycline-based chemotherapy
* CT scans showing involvement of 1 or more clearly demarcated lesions with a long axis \> 1.5 cm and short axis \>= 1.0 cm
* Baseline FDG-PET/CT scans must demonstrate at least one hypermetabolic lesion as defined by the Deauville criteria localizing to CT-defined anatomical tumor sites
* Suitable candidate for therapy with standard salvage chemotherapy and autologous stem cell transplant (ASCT) as determined by the treating physician
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Life expectancy of \>= 12 weeks as estimated by the treating physician
* Negative serum beta-human chorionic gonadotropin (beta-hCG) test (women of childbearing potential only)
* Hemoglobin \>= 8.5 g/dL
* Absolute neutrophil count (ANC) \>= 1500/mm\^3
* Platelet count \>= 75,000/mm\^3
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 5 x institutional upper limit of normal (ULN) for cases involving liver metastasis and =\< 3 x institutional ULN for all other cases
* Bilirubin =\< 2 x ULN (unless related to lymphoma) or =\< 5 x ULN for subjects with documented or suspected Gilbert's disease
* Serum creatinine =\< 1.5 x ULN or calculated creatinine clearance (CrCl) \>= 50 mL/min as determined by the Cockcroft-Gault equation
Exclusion Criteria:
* Any condition that, in the opinion of the investigator, would interfere with the interpretation of study results or subject safety including non-malignant FDG avid diseases such as sarcoidosis or other granulomatous disease
* Uncontrolled diabetes mellitus
* Concurrent enrollment in another clinical study where they are receiving non-standard salvage chemotherapy, (i.e., concurrent enrollment is allowable if the patient is receiving standard salvage chemotherapy and research imaging is allowed)
* Any chemotherapy, radiotherapy, immunotherapy, biologic, or investigational therapy for treatment of lymphoma within 14 days prior to treatment
* Symptomatic congestive heart failure | 35,770 |
Study Objectives
Prospective \& Retrospective data collection of breast cancer cases from 2000 to present
Conditions: Breast Cancer
Intervention / Treatment:
OTHER: Breast Cancer database
Location: Saudi Arabia
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: EARLY_PHASE1
Primary Purpose:
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Patients with breast cancer | 12,365 |
Study Objectives
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of irinotecan plus ICI D1694 in treating patients with advanced solid tumors.
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Intervention / Treatment:
DRUG: irinotecan hydrochloride, DRUG: raltitrexed
Location: United States
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: TREATMENT
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS: Histologically confirmed solid tumor for which no effective therapy exists Measurable or evaluable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0 or 1 Hematopoietic: WBC at least 3,000 AGC at least 1,500 Platelets at least 100,000 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 5 times normal Renal: Creatinine no greater than 1.5 mg/dL Metabolic: Glucose no greater than 200 mg/dL Electrolytes within 10% normal Other: No active infection that contraindicates entry No significant medical problem that contraindicates entry Effective contraception required of fertile patients Able and willing to participate in pharmacokinetic sampling
PRIOR CONCURRENT THERAPY: At least 3 weeks since chemotherapy (6 weeks since mitomycin or nitrosoureas) and recovered At least 3 weeks since radiotherapy and recovered | 15,400 |
Study Objectives
The purpose of the study is the identification and semi-quantification of Ki-67 protein expression level in breast cancer tissues by the GenASIs GoPth system as compared to manual reading of the same slides.
The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying ER/PR IHC stained samples
Conditions: Breast Cancer
Intervention / Treatment:
PROCEDURE: Women with Breast Cancer
Location:
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Slides with nuclear borders of tumor nuclei that is distinguishable, and having good integrity.
Exclusion Criteria:
* Slides that have lots of background that interfere with the analysis | 9,766 |
Study Objectives
Primary Objective:
To evaluate safety of rasburicase in pediatric patients with NHL and AL
Secondary Objective:
To assess efficacy of rasburicase for prevention and treatment of hyperuricemia
Conditions: Lymphoma
Intervention / Treatment:
DRUG: RASBURICASE SR29142
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion criteria :
* Patient or parent/legal guardian is willing and able to provide signed informed consent, and if required, the patient is willing to provide assent.
* Children or adolescent aged 2 to 18 years old (inclusive) at time of signing of informed consent.
* At screening, the patient is expected to have a minimum life expectancy of 45 days and has a performance status (PS) no greater than 3 on the Eastern Cooperative Oncology Group (ECOG) scale, or a PS no less than 30 on the Lansky score as per the Investigator's preference (see Appendix D for ECOG and Lansky scale).
* Newly diagnosed NHL or AL who is at the initiation of or during the first cycle of chemotherapy,baseline blood uric acid greater than 8 mg/dL (473 mol/L) at screening.
* If newly diagnosed NHL patient with blood uric acid no greater than 8 mg/dL at screening, the patient must be diagnosed with Stage III or IV non-Hodgkin's lymphoma with high tumor burden which will be high risk of TLS defined, with one or more of following below: A. Burkitt lymphoma/leukemia or -lymphoblastic lymphoma, and/or B. Has at least one of lymph node or tumor, the diameter \>5 cm, and/or C. Lactate dehydrogenase (LDH) no less than 2 times the upper limit of normal (ULN).
* If newly diagnosed AL patient is with blood uric acid no greater than 8 mg/dL at the screening but with a high risk of TLS defined with one of the following below criteria: A. White blood cell (WBC) no less than 100.0 10-9/L, or B. WBC \< 100.0 10-9/L with LDH no less than 2 ULN.
* The patient will receive the chemotherapy, and will be confined in hospital for at least 14 days after first dose of rasburicase.
Exclusion criteria:
* Acute promyelocytic leukemia
* Patient who has been treated or planned to receive allopurinol within 72 hours of rasburicase administration.
* Patients with abnormal liver or renal function: alanine aminotransferase (ALT) \>5 ULN, total bilirubin \>3 ULN, serum creatinine \>3 ULN.
* Documented history of hereditary allergy or asthma.
* Patients with known deficiency of glucose-6-phosphate dehydrogenase (G6PD), or a history of hemolytic disease or methemoglobinemia.
* Patients with severe infection or active bleeding.
* Previous therapy with urate oxidase.
* Hypersensitive reaction against rasburicase or any of the other ingredients of the study drug.
* Patient is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures.
* Pregnant or breastfeeding woman.
* Woman of childbearing potential (WOCBP) not protected by highly-effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy (see contraceptive guidance in Appendix A).
* Male participant with a female partner of childbearing potential not protected by highly-effective method(s) of birth control
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. | 33,334 |
Study Objectives
The purpose of this study is to make a preliminary assessment of the efficacy of a combined APR-246 and PLD chemotherapy regimen in patients with platinum-resistant recurrent high grade serous ovarian cancer (HGSOC) with mutated TP53. In addition, the study aims to assess the safety profile of the combined APR-246 and PLD chemotherapy regimen, to evaluate potential biomarkers, and to assess the biological activity in tumor and surrogate tissues. The trial will enroll at least 25 evaluable patients.
Conditions: High-grade Serous Ovarian Cancer
Intervention / Treatment:
DRUG: APR-246, DRUG: Pegylated Liposomal Doxorubicin Hydrochloride (PLD)
Location: Spain, United Kingdom, Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Confirmed High Grade Serous Ovarian Cancer, and positive nuclear immunohistochemical (IHC) staining for p53
* Disease Progression between 4 weeks - 6 months after the last platinum-based treatment was administered
* At least a single measurable lesion
* Adequate organ function prior to registration
* Toxicities from previous cancer therapies (excluding alopecia) must have recovered to grade 1 (defined by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0). Chronic stable grade 2 peripheral neuropathy secondary to neurotoxicity from prior therapies may be considered on a case by case basis
* ECOG performance status of 0 to 2
Exclusion Criteria:
* Prior exposure to cumulative doses of doxorubicin \>400 mg/m2 or epirubicin \>720 mg/m2
* Hypersensitivity to PLD or to any of the excipients
* Unable to undergo imaging by either CT scan or MRI
* Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment related complications
* Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ)
* Is taking concurrent (or within 4 weeks prior to registration) chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation). Supportive care measures are allowed. Palliative limited radiation therapy for pain reduction is allowed | 20,232 |
Study Objectives
The purpose of this study is to evaluate the safety and efficacy of the combined therapy using irreversible electroporation（IRE）and nature killer(NK) cells for advanced pancreatic cancer.
Conditions: Pancreatic Cancer
Intervention / Treatment:
BIOLOGICAL: NK cells, PROCEDURE: irreversible electroporation (IRE )
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. Age:18-80
2. Diagnosis：advanced and active pancreatic cancer
3. The tumour is measurable
4. Eastern Cooperative Oncology Group(ECOG) score：0\~2；3 but has no relationship with tumour
5. Vital organ function is normal:
total bilirubin(TB) \<68μmol/L aspartate aminotransferase(AST)\<90 IU/L Cre\<353μmol/L white blood cell count(WBC)\<9×10\^9/L,when WBC is close to or even greater than 9×10\^9/L，the recommended dose should be halved platelet count(PLT)\>80×10\^9/L Red blood cell specific volume(HCT)\>0.20 Non severe viral or bacterial infection
6. Non pregnant and lactating patients
7. Non allergic reactions to biological products
8. Informed and consent
Exclusion Criteria:
1. Patients with cardiac pacemaker
2. Patients with severe cardiac and pulmonary dysfunction
3. Patients that the researchers do not think fit into the group,including patients failed in compliance assessment | 30,648 |
Study Objectives
The investigators study is to investigate safety and efficacy of performing a planned incomplete removal of large acoustic neuroma tumors to decrease surgical morbidity and yet avoid tumor recurrence by post-operative radiation therapy.
Conditions: Neuroma, Acoustic
Intervention / Treatment:
PROCEDURE: Microsurgery, PROCEDURE: Stereotactic radiation therapy
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Adult patients with acoustic neuromas the widest diameter of 2.5 cm or larger at the cerebellopontine angle are eligible for this trial.
* Patients that are deemed good surgical candidates based on age, general health, genetic predispositions, and hearing in contralateral side would be included as the subjects of this trial.
* Although we would include patients with neurofibromatosis II in this trial, considering their genetic predisposition for recurrence, we would analyze their outcome as a separate group.
Exclusion Criteria:
* Patients who have received any form of treatment of their acoustic neuromas prior to enrollment in the study including surgery or radiation therapy. | 28,575 |
Study Objectives
Background:
- Normal bacteria and other tiny organisms (the microbiota) live in the mouth and nose. They contribute to human health in many ways, including digesting food and balancing hormones. Testing samples from the mouth can show how microbiotas are related to health and disease. However, the microbiota in a person's mouth differs depending on the methods of collection and the part of the mouth that is tested. Understanding what can change the microbiota (including mouth sites, and what a person eats or smokes) will give more information on how to study oral microbiota and smoking-related cancers and other diseases.
Objectives:
* To see how smoking affects the microbiotas in mouth and nose.
* To determine which collection method for mouth specimens should be used for studying microbiota.
Eligibility:
* Individuals at least 18 years of age who have been using tobacco products regularly for at least 5 years.
* Individuals at least 18 years of age who have never smoked.
Design:
* Participants will be screened with a physical exam and medical history.
* Participants will have a dental exam. They will provide a saliva sample. The dentist will take swabs from the inside of the mouth, including the tongue, tonsils, gums, and teeth. The inside of the nose will also be swabbed.
* Participants will also fill out a questionnaire. It will ask about their history of smoking and consumption of alcohol, tea, and coffee. It will also ask about current medications, including antibiotics.
Conditions: Microbiota, Lung Cancer, Oral Cancer
Intervention / Treatment:
Location: United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | * INCLUSION CRITERIA
This study will recruit a convenience sample of 50 volunteers (25 current smokers with at least 5 years of smoking history, 25 never smokers). Current smokers are defined as individuals who have smoked more than 100 cigarettes in their lifetime and have smoked 5 or more cigarettes in the last 24 hours. Recent use of other tobacco products (pipe, cigar, snuff, cigarillos, and chewing tobacco) is an overall exclusion, but use in the remote past (\> 6 month ago) is acceptable in smokers. Never smokers are defined as individuals who have never smoked cigarettes nor used any other tobacco products including pipe, cigar, snuff, cigarillos, or chewing tobacco.
The ethnic mix of the clinic is roughly 50% Caucasians and 50% African- Americans with a small number of unspecified or other racial groups. The median age is about 50 and the gender mix consists of an equal number of men and women. We therefore will select smokers and frequency match to non-smokers based on ethnicity (White, African-American), gender (male, female), and age (above or below the median, estimated to be 50).
EXCLUSION CRITERIA
We will exclude pregnant women and other racial groups because they may represent very small numbers and thus be difficult to match. Hormonal changes associated with pregnancy and unique cultural habits associated with specific ethnic groups could be associated with highly unique or variable microbiome patterns, and therefore reduce the power to detect differences associated with smoking which is our primary goal. We will also exclude subjects with antibiotic usage in the last three months and subjects with previous diagnosed major periodontal disease or cancer because they might be potential confounders. | 35,439 |
Study Objectives
Lung cancer screening with low-dose computed tomography (LDCT) has been recently shown to result in a significant reduction in lung cancer-specific mortality. However, the utility of LDCT screening in developing countries with high incidence of tuberculosis has not been adequately studied. The investigators hypothesize that LDCT screening in tuberculosis endemic regions is likely to yield a large proportion of false-positive results, especially in the initial round of screening, posing a significant burden on the healthcare system. Herein, the investigators assess the utility of LDCT and its cost-effectiveness in India.
Conditions: Lung Cancer
Intervention / Treatment:
DIAGNOSTIC_TEST: Low-dose computed tomography of chest
Location: India
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: NA
Primary Purpose: SCREENING
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Individuals aged 55-74 years with at least 30 pack-year history of smoking (or smoking index ≥600) who are current smokers or quit within the last 15 years OR
* Individuals aged 50-74 years with at least 20 pack-year history of smoking (or smoking index ≥400) who are current or former smokers with COPD or family history of lung cancer in any first-degree relative
Exclusion Criteria:
* Symptomatic structural lung disease other than COPD (e.g. bronchiectasis, chronic pulmonary aspergillosis, pulmonary fibrosis)
* Severe comorbid condition which is likely to limit the survival of the patient in the opinion of the investigator (e.g. advanced lung disease, cardiovascular disease, chronic kidney disease, chronic liver disease)
* Presence of symptoms which lead to a suspicion of lung cancer (e.g. hemoptysis or unexplained weight loss \[\>5 kg\] within the last 6 months)
* Conditions which may interfere interpretation of CT (e.g. metallic implants on chest wall, cardiac pacemakers)
* Treatment for any other cancer in the last 5 years
* Pulmonary infection (for which treatment with antimicrobials is indicated) which is active at present or was recent (within the last 3 months)
* Patients who have underwent CT chest within the last 18 months
* Negative consent | 21,102 |
Study Objectives
Non-randomized, open label, multicentric translational research study in women with untreated invasive breast carcinoma eligible for primary surgery (Stage I-IIIA).
The aim of PAMELA is to test the hypothesis that PAM50 HER2-enriched (HER2-E) subtype better predicts response to neoadjuvant dual anti-HER2 blockade, with or without endocrine therapy, compared to traditional clinical HER2 classification. Furthermore, we posit that characterization of gene expression patterns may identify profiles of those who may be safely spared chemotherapy.
Conditions: Breast Cancer
Intervention / Treatment:
DRUG: Lapatinib, DRUG: Trastuzumab, DRUG: Endocrine Therapy, DRUG: Paclitaxel
Location: Spain
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
* Written informed consent prior to beginning specific protocol procedures
* Untreated invasive breast carcinoma eligible for primary definitive surgery (stage I-IIIA)
* Histologically confirmed invasive breast carcinoma, with all of the following characteristics: primary tumor ≥1 cm in largest diameter, cN0-2, No evidence of distant metastasis (M0)
* HER2-positive invasive breast cancer by central assessment, defined by ASCO/CAP guidelines
* Female patients
* Age ≥18 years
* ECOG performance status of 0 or 1
* Adequate organ function defined as: Absolute neutrophil count (ANC) ≥1.5 × 109/L, Hemoglobin (Hgb) ≥10 g/dL, Platelets \>100 000/mm3, Creatinine ≤1.6 mg/dL, ALT and AST ≤2.5 × ULN, Alkaline phosphatase ≤5 ULN, Total bilirubin ≤1.5 mg/dL, Baseline LVEF ≥50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan
* Negative β-HCG pregnancy test (serum) for premenopausal women of reproductive capacity (those who are biologically capable of having children) and for women less than 12 months after the menopause. All subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from 2 weeks before administration of the first dose of investigational product until 28 days after last dose of investigational product
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* In the case of multifocal tumor (defined as the presence of two or more tumor foci in the same quadrant of the breast), the largest lesion must be ≥ 1 cm, and "target lesion" must be designated for all subsequent tumor assessments. In all tumor foci should be documented HER2 status as positive
* Availability of enough tumor sample or possibility to take a new biopsy for PAM50 analysis
Exclusion Criteria:
* Stage III inoperable breast cancer or known metastatic disease
* Patients for whom upfront chemotherapy including taxanes and anthracyclines is clinically judged appropriate as optimal neoadjuvant treatment
* Prior chemotherapy, radiotherapy or surgery for invasive breast cancer, other than excision of tumor in the contralateral breast, and provided that the patient did not previously receive adjuvant radiotherapy or chemotherapy
* Subjects with a concurrently active second malignancy, other than adequately treated non-melanoma skin cancers, in situ melanoma or in situ cervical cancer. Subjects with other non-mammary malignancies must have been disease-free for at least 5 years
* Known or suspected hypersensitivity reaction to any investigational or therapeutic compound or their incorporated substances
* Concurrent congestive heart failure or LVEF \<50%
* Clinically significant (i.e. active) cardiovascular disease, including cerebrovascular accident (\<6 months before enrollment), unstable angina pectoris, myocardial infarction ≤6 months before enrollment, uncontrolled hypertension (systolic \>150 mmHg and/or diastolic \>100 mmHg) or high-risk uncontrolled arrhythmias
* Uncontrolled diabetes mellitus, active peptic ulcer disease or uncontrolled epilepsy
* Active uncontrolled infection at the time of enrollment
* History of significant comorbidities that, in the judgment of the investigator, may interfere with the conduction of the study, the evaluation of response, or with informed consent
* Use of any investigational agent or participation in another therapeutic clinical trial concurrently or in the previous 30 days before the enrollment
* Patients who are pregnant or breast-feeding
* Women of child-bearing potential who are unable or unwilling to use contraceptive measures
* Inability or unwillingness to abide by the study protocol or cooperate fully with the investigator
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded
* Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies)
* Concomitant use of CYP3A4 inhibitors or inducers | 19,719 |
Study Objectives
The purpose of this study is to examine adherence to cardio-oncology consultation.
Conditions: Cancer
Intervention / Treatment:
OTHER: Cardiac Aggressive Risk MitigAtion Plan
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:
* Any stage (I-IV) malignancy being treated with high dose (≥30 Gy) radiotherapy where the heart is in the treatment field.
* Have Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2.
* Planning to receive standard of care radiotherapy treatments.
* Access to a smart device that has the capability to sync to the devices.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
* Ability to read, write and understand English.
Exclusion Criteria:
* Known allergy to surgical steel or elastomer/rubber.
* Heart attack within 6 months prior to study enrollment.
* Severe and/or active scleroderma or systemic lupus erythematosus. | 33,622 |
Study Objectives
The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.
Conditions: Chemotherapy Induced Oral Mucositis
Intervention / Treatment:
DRUG: oral quercetin capsules, DRUG: Placebo
Location: Iran, Islamic Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: QUADRUPLE | Inclusion Criteria:
* patient under chemotherapy
* for a hematologic malignancy
* the hematologist permits the trial on the patient
* agreement of patient for participating in the trial
Exclusion Criteria:
* presence pf ANY oral lesion at the beginning of the trial
* loss of follow up
* use of digoxin and cyclosporine
* patient death | 37,145 |
Study Objectives
The goal of Part 1 of this clinical research study is to find the highest dose of (Imbruvica) ibrutinib that can be given to patients with non-small cell lung cancer (NSCLC). The goal of Part 2 of this clinical research study is to learn if the dose of ibrutinib found in Part 1 can help to control the disease.
The safety of this drug will also be studied in both parts of the study.
Conditions: Lung Cancer
Intervention / Treatment:
DRUG: Ibrutinib
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. Patients must have histologically or cytologically confirmed stage IV non-small cell lung cancer, or recurrent non-small cell lung cancer which is not amenable to curative intent therapy.
2. Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors(RECIST) 1.1 criteria
3. For EGFR mutant cohort, patients must have: a) Documented EGFR mutation by Clinical Laboratory Improvement Amendments (CLIA)-certified test b) Documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other EGFR-targeted tyrosine kinase inhibitor c) Tissue available from a biopsy or surgical procedure performed after progression on an EGFR targeted tyrosine kinase inhibitor. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy.
4. For HER2 mutant cohort, patients must have: a) Documented EGFR mutation by CLIA-certified test b)Documented disease progression on treatment with erlotinib, gefitinib, afatinib, or other EGFR-targeted tyrosine kinase inhibitor c)Tissue available following progression on most recent systemic therapy. If tissue is not available, the patient must have biopsy accessible disease and must be willing to undergo a biopsy.
5. Age \>/=18 years
6. Eastern Cooperative Oncology Group (ECOG) performance status \</=2
7. Ability to take pills by mouth
8. Patients must have normal organ and marrow function as defined: leukocytes \>/= 3,000/mcL; absolute neutrophil count \>/= 1,500/mcL; hemoglobin \>/= 9 g/dL; total bilirubin \</= 1.5 x institutional upper limit of normal (ULN); AST(SGOT)/ALT(SGPT) \</= 2.5 × ULN or \</= 5 x ULN if metastases to the liver; creatinine clearance \>/= 45 mL/min
9. Patients with asymptomatic brain metastases are allowed, as long as they are stable and do not require treatment with anticonvulsants or escalating doses of steroids. Maximum daily dose of steroids should be prednisone 20 mg or equivalent. Radiation therapy for brain metastases must be completed at least 14 days prior to treatment on protocol
10. The effects of ibrutinib on the developing human fetus are unknown. Women of child-bearing potential and men must agree to use highly effective contraception (if using hormonal birth control must add a second barrier method; abstinence) prior to study entry, for the duration of study participation as well as for at least 1 month after the last dose of ibrutinib. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use highly effective contraception prior to the study, for the duration of study participation and 3 months after completion of ibrutinib administration.
11. Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
1. Patients who have received EGFR tyrosine kinase inhibitors within 72 hours of initiation of study treatment, or treatment with other anti-cancer agents within 21 days of study treatment
2. Prior treatment with ibrutinib
3. Known hypersensitivity to ibrutinib
4. Concurrent use of agents that strongly inhibit or induce CYP3A unless use is approved by the medical monitor
5. 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
6. Pregnant and nursing women
7. Patients with a history of another active malignancy within the past two years, with the exception of non-melanoma cutaneous malignancy, cervical carcinoma in situ, or ductal carcinoma in situ which has been successfully treated with curative intent therapy
8. Any gastrointestinal disorder expected to limit absorption of ibrutinib
9. Treatment with warfarin or other vitamin K antagonist. Patients with using warfarin who switch to another form of anticoagulation will be eligible
10. Patients with persistent and uncontrolled atrial fibrillation. | 23,020 |
Study Objectives
This is a retrospective study, including 79 patients with duodenal papillary adenoma, who treated with Endoscopic Papillectomy (EP) at Beijing friendship hospital. The cohort included patients who underwent EP with or without Pancreatic Duct (PD) and Common Bile Duct (CBD) stent placement. The investigators assessed the outcomes of EP and the impact of stent placement on complications and recurrence rates.
Conditions: Duodenal Adenoma, Complication of Treatment
Intervention / Treatment:
PROCEDURE: Stent Placement in Pancreatic and Bile Ducts
Location: China
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | Inclusion Criteria:
* Age ≥18 years.
* Identification of duodenal papillary lesions via gastroscopy or duodenoscopy.
* Intraductal involvement \<20mm.
* Absence of preoperative peripheral lymph node metastasis and pancreatic/biliary duct stenosis (verified by CT, MRI, or other imaging).
* Postoperative biopsy confirming adenoma.
Exclusion Criteria:
* Diagnosis of familial adenomatous polyposis or multiple hamartoma syndrome.
* Patients undergoing pancreaticoduodenectomy within a month post-EP for residual lesions. | 9,961 |
Study Objectives
The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.
Conditions: Lung Cancer, Small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung
Intervention / Treatment:
DRUG: Ipilimumab, DRUG: Placebo, DRUG: Paclitaxel, DRUG: Carboplatin
Location: Ukraine, India, Poland, Germany, United States, France, Russian Federation, Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer \[SCLC\])
* Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
* Eastern Cooperative Oncology Group performance status of ≤1 at study entry
* Accessible for treatment and follow-up
Exclusion Criteria:
* Brain metastases
* Malignant pleural effusion
* Autoimmune disease
* Motor neuropathy of autoimmune origin
* SCLC-related paraneoplastic syndromes
* Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
* Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.
* Grade 2 peripheral neuropathy (motor or sensory)
* Known HIV or hepatitis B or C infection
* Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
* Inadequate hematologic function defined by an absolute neutrophil count \<1,500/mm\^3, a platelet count \<100,000/mm\^3, or hemoglobin level \<9 g/dL.
* Inadequate hepatic function defined by a total bilirubin level \>2.0 times the upper limit of normal (ULN), or ≥2.5 times the ULN if liver metastases are present, aspartate aminotransferase and alanine aminotransferase levels ≥2.5 times the ULN or ≥5 times the ULN if liver metastases are present.
* Inadequate renal function defined by a serum creatinine level ≥2.5 times the ULN
* Inadequate creatinine clearance defined as less than 50 mL/min. | 25,445 |
Study Objectives
This is non randomised, open label, dose finding, efficacy and safety study, enrolling patients with advanced (stage III and IV) ovarian cancer It will be conducted in two successive phases. Phase II has a two-step design
Conditions: Ovarian Cancer
Intervention / Treatment:
DRUG: CP-4055, DRUG: CP-4055
Location: Italy, Belgium
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Primary Purpose: TREATMENT
Allocation: NA
Interventional Model: SINGLE_GROUP
Masking: NONE | Inclusion Criteria:
* Histologically or cytologically documented advanced epithelial ovarian cancer measurable with CT and/or MRI
* Received prior chemotherapy regimen(s) for ovarian cancer, at least one being a platinum based therapy (PBT)
* Evidence of platinum resistant or refractory disease
* ECOG Performance Status 0 - 1
* Life expectancy \> 3 months
* Signed informed consent (IC)
* Women of child-bearing potential must have a negative serum or urine pregnancy test. Nursing patients are excluded.
* Women of child-bearing potential must not become pregnant while participating in the study
* Adequate haematological and biological functions
Exclusion Criteria:
* Patients with mixed mullerian tumours (MMT) (carcinosarcomas)
* Known brain metastases
* Another known active cancer within the last 5 years
* Radiotherapy to more than 30 % of bone marrow
* Participation in another therapeutic clinical study within 30 days of enrolment or during this clinical study
* Concomitant treatment with a non-permitted medication
* A history of allergic reactions or sensitivity attributed to compounds of similar or biological composition to CP-4055, i.e., ara-C and/or egg
* Any serious concomitant systemic disorders incompatible with the clinical study
* Any significant CNS or psychiatric disorder(s) that would hamper the patient's compliance
* Pregnancy or breastfeeding
* Known positive status for HIV and/or hepatitis B or C
* Drug and/or alcohol abuse
* Any reason why, in the investigator's opinion, the patient should not participate | 31,056 |
Study Objectives
To evaluate the safety and immunogenicity of the 9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha) in Chinese Female Subjects Aged 9-45 Years.
Conditions: Cervical Cancers, Vulvar Cancer, Vaginal Cancer, CIN1, CIN2, CIN 3, AIS, Invasive Carcinoma, Mild Dysplasia of Vulva, Moderate Dysplasia of Vulva, Vin III, VaIN1, VaIN2, VaIN3, Genital Wart
Intervention / Treatment:
BIOLOGICAL: 9-valent HPV Recombinant Vaccine, BIOLOGICAL: Placebo
Location: China
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE1
Primary Purpose: PREVENTION
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* Healthy females between, and including, 9 and 45 years of age at the time of enrolment
* Be able to provide legal identification for the sake of recruitment
* Be able to understand and sign informed consent form prior to enrollment and for subjects aged 9-17 years, they and their legal guardian(s) are supposed to understand and sign informed consent form together
* Subjects who the investigator believes that they can and will comply with the protocol requirements
* Subject must be not pregnant at the enrollment and agree to use adequate contraceptive precautions within 7 months or don't have pregnancy plan
Exclusion Criteria:
* Fever or axillary temperature\> 37.0℃ before vaccination
* Previous vaccination against HPV
* Planned administration/administration of investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding first dose of vaccine
* Planned to take part in other clinical research within 7 months after participating this study or have taken part in other clinical research within 3 months before participating this study
* Abnormal laboratory tests parameters(except the part the clinician diagnosed as non clinical significance)
* Administration of any whole blood, plasma or immunoglobulins products within 3 months preceding first vaccination
* Interval between administration of the study vaccination and any attenuated live vaccine less than 14 days, and other vaccines less than 10 days
* History of serious allergic disease requiring medical intervention (such as oral and throat swelling, difficulty breathing, hypotension or shock)
* History of to adverse event to vaccine, or allergic to some food or drug
* History of epilepsy, seizures or convulsions, or family history of mental illness
* Subjects are immunocompromised or have been diagnosed as suffering from congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis inflammation (JRA), inflammatory bowel disease or other autoimmune diseases, administration of immunosuppressants with six months prior to the first vaccine dose.
* Asplenia, functional asplenia, or any circumstances result of asplenia or splenectomy
* Subject to severe hepatorenal disease, cardiovascular disease, hypertension, diabetes, malignant tumor, all kinds of infectious diseases and acute illness, or during chronic disease acute attack period
* Medical diagnosis of coagulation abnormalities (eg, clotting factor deficiency, coagulation disorders, platelet anomaly) or obvious bruising or coagulation disorder
* Breastfeeding, pregnancy (including pregnancy test positive), or planned to be pregnant within 7 months
* During acute disease (including infectious and non-infectious disease) and chronic diease period of onset
* Abnormal cervical cancer screening or subject to CIN or acuteness wet wart that relevant to HPV infection in the past two years
* Planned to move out of local before the end of the study or leave the local for a long time during the study period
* Other unsuitable factors for the study judged by investigators | 22,823 |
Study Objectives
Context: Metformin administration in women with polycystic ovary syndrome (PCOS) improves hormonal and metabolic patterns with beneficial effects in terms of reproductive outcomes and intermediate cardiovascular disease risk factors. Furthermore, reduced folate and vitamin B12, and increased homocysteine (Hcy) levels have been found in type-2 diabetes mellitus patients treated with metformin.
Objective: To evaluate if metformin administration exerts any effects on Hcy levels, and if folate supplementation may improve endothelial structure and function in PCOS patients.
Conditions: Polycystic Ovary Syndrome, Anovulation
Intervention / Treatment:
DRUG: Folate plus metformin, DRUG: Placebo plus metformin
Location: Italy
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE4
Primary Purpose: PREVENTION
Allocation: NON_RANDOMIZED
Interventional Model: PARALLEL
Masking: DOUBLE | Inclusion Criteria:
* PCOS
Exclusion Criteria:
* age \<18 or \>35 years
* BMI \>35 kg/m2
* neoplastic, metabolic, hepatic, renal, and cardiovascular disorders
* Current or previous use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic and anti-obesity drugs or other hormonal drugs. | 13,984 |
Study Objectives
The primary purpose of this trial is to compare the efficacy and safety of DS-8201a and physician's choice treatment in HER2-overexpressing advanced gastric or gastroesophageal junction adenocarcinoma patients who have progressed on two prior treatment regimens including fluoropyrimidine agent, platinum agent, and trastuzumab.
Conditions: Neoplasm, Gastrointestinal
Intervention / Treatment:
DRUG: DS-8201a, DRUG: Physician's Choice
Location: Japan, Korea, Republic of
Study Design and Phases
Study Type: INTERVENTIONAL
Phase: PHASE2
Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE | Inclusion Criteria:
1. Has a pathologically documented locally advanced or metastatic adenocarcinoma of gastric or gastroesophageal junction
2. Progression on and after at least 2 prior regimens
3. Has an adequate tumor sample
4. Has measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1
Exclusion Criteria:
1. Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
2. Has a QTc prolongation to \> 450 millisecond (ms) in males and \> 470 ms in females
3. Has a medical history of clinically significant lung disease
4. Is suspected to have certain other protocol-defined diseases based on imaging at screening period
5. Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
1. safety or well-being of the participant or offspring
2. safety of study staff
3. analysis of results | 17,419 |
Study Objectives
The purpose of this study is to determine the rate of response with the combination of erlotinib and bevacizumab in previously treated patients with thymoma or thymic carcinoma, and to determine potential molecular markers that may predict response to therapy in patients with thymoma or thymic carcinoma.
Conditions: Thymic Cancer, Thymoma
Intervention / Treatment:
DRUG: bevacizumab, DRUG: Erlotinib
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 invasive, recurrent or metastatic thymoma or thymic carcinoma not amenable to potentially curative therapy by surgery in the opinion of the investigator. Original biopsy of tumor is sufficient for diagnoses unless otherwise clinically indicated.
* Patients must have measurable disease per RECIST. Note: Any scans or x-rays used to document measurable disease must be obtained within 28 days prior to registration.
* Patients must have had prior chemotherapy (no limit for prior regimens) for metastatic disease.
* Patients must not have had any form of systemic anticancer therapy within 21 days prior to being registered for protocol therapy.
* Patients receiving radiation therapy must have completed their radiation at least 21 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to ≤ grade 1 or baseline prior to registration. Previously radiated area(s) must not be the only site of disease.
* Be at least 18 years of age at the time of consent.
* Patient's must have laboratory data as specified below within 14 days of registration to study:
1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal (ULN) (unless liver metastases are present, in which case AST/ALT ≤ 5 times upper limit of normal will be acceptable).
2. Total bilirubin ≤ 1.5 mg/dl.
3. White blood cell (WBC) count \> 3000/mm3
4. Absolute neutrophil count (ANC) ≥ 1500/mm3
5. Platelets ≥ 100,000/mm3
6. International normalized ration (INR) of prothrombin time ≤ 1.2, and aPTT no more than 5 seconds longer than the ULN
7. Urine protein:creatinine ratio 1.0 at screening.
* Patients must not have prior history of malignancy in the past 5 years with the exception of basal cell and squamous cell carcinoma of the skin. Other cancers with low potential for metastasis, such as in situ cancers (e.g., Grade 1, TA TCC (low grade superficial bladder cancer), colonic polyp with focus of adenocarcinoma) can also be enrolled after approval from the study chair.
* No prior use of an EGFR inhibitor or anti-angiogenic agent.
* No use of an investigational agent within 30 days prior to registration for study protocol.
* Must not have any contraindications to the use of erlotinib or bevacizumab as per the package labeling for either product.
* No uncontrolled hypertension ( e.g. \> 150/100 mmHg pretreatment)
* No history of unstable angina.
* No history of New York Heart Association (NYHA) Grade II or greater congestive heart failure
* No history of myocardial infarction or angina pectoris/ anginal equivalent in the last 6 months (the patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months )within 6 months prior to registration for protocol therapy.
* No history of stroke within 6 months prior to registration for protocol therapy.
* No clinically significant peripheral vascular disease.
* No evidence of bleeding diathesis or coagulopathy.(Low dose anticoagulant therapy to maintain patency of a vascular access device is allowed).
* Patients must not have been using aspirin (\>325 mg/day) or another nonsteroidal anti-inflammatory medications known to inhibit platelet function daily within 10 days prior to registration..
* Patients may not be taking the following drugs known to inhibit platelet function: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal).
* No known evidence of central nervous system involvement or brain metastases. If symptomatic must be confirmed by Head CT or Brain MRI within 6 weeks prior to being registered for protocol therapy.
* No major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy.
* No anticipation of need for major surgical procedure during the course of the study.
* No minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
* No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to registration for protocol therapy.
* No serious, non-healing wound, ulcer, or bone fracture.
* No history of hemoptysis.
* No history of deep vein thrombosis or pulmonary embolism.
* No active infections. | 8,613 |
Study Objectives
RATIONALE: Quality-of-life assessment in cancer survivors may help determine the long-term effects of having had gynecologic cancer and may help improve the quality of life for future cancer survivors.
PURPOSE: This clinical trial is studying the quality of life in survivors of gynecologic cancer.
Conditions: Endometrial Cancer, Ovarian Cancer
Intervention / Treatment:
PROCEDURE: quality-of-life assessment
Location: Canada, United States
Study Design and Phases
Study Type: OBSERVATIONAL
Phase:
Primary Purpose:
Allocation:
Interventional Model:
Masking: | DISEASE CHARACTERISTICS:
* Histologically confirmed early stage ovarian and endometrial cancer survivors treated and diagnosed five or more years ago
* Patients completing treatment in GOG-95 or GOG-99 protocols at least 5 years ago with no recurrence of disease
* Patients with secondary malignancy or under treatment for other medical conditions are eligible
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Must be capable of completing telephone interview in English
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* See Disease Characteristics
Radiotherapy:
* See Disease Characteristics
Surgery:
* See Disease Characteristics | 14,594 |
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