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Study Objectives
Primary Objectives:
1. To collect data on health behaviors in the parents of MATCh study participants
2. To collect and/or update risk factor data from the parents of the MATCh study participants.
Intervention / Treatment
BEHAVIORAL: Supplemental Survey
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Inclusion Criteria:
* The parent or legal guardian of the child participating in UT MDACC Protocol 2004-* Parents/legal guardians will be identified and enrolled after their child is enrolled in protocol 2004-*
* Participants who speak English, Spanish or are bilingual are eligible to participate.
Exclusion Criteria: None
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Study Objectives
This is a study to evaluate the safety and pharmacokinetics in pediatric patients with secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of hemodialysis.
Intervention / Treatment
DRUG: Etelcalcetide
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Inclusion Criteria:
* Subject's parent has provided informed consent and subject has provided assent
* Children Age 2 to less than 18 years
* Diagnosed with chronic kidney disease
* Diagnosed with secondary hyperparathyroidism receiving hemodialysis,
* Weighing at least 7 kg
* Laboratory results within specified range.
Exclusion Criteria:
* Currently receiving treatment in another investigation device or drug study
* Subject has received cinacalcet therapy within 30 days
* History of prolongation QT interval
* Subject is taking any medications that are on the QT prolongation medication list
* Electrocardiograph (ECG) measurements within specified range.
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Study Objectives
The objective of our study is to determine the effects of fish protein on insulin sensitivity in PCOS women with insulin resistance, and its mechanism of action on glucose and endocrine metabolism. Our working hypothesis is that dietary fish protein improves insulin sensitivity, glucose tolerance, and related plasma endocrine and lipid abnormalities in PCOS women by restoring secretory β-cell function and insulin signaling to the PI 3-kinase activity/Akt pathway. We further hypothesize that fish protein will improve cycle regularity and ovarian function.
Intervention / Treatment
OTHER: Semi-controlled nutritional intervention with fish protein diet, OTHER: Semi-controlled intervention with other animal proteins
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Inclusion Criteria:
* women
* 18 to 45 years old
* having polycystic ovarian syndrome
* overweight (BMI>27)
* insulin resistance based on fasting insulin levels in the upper 95th percentile (>90pmol/L)
* non-diabetic
Exclusion Criteria:
* diabetes
* hysterectomy
* abnormal endometrial biopsy if abnormal bleeding in the last 6 months
* clinical evidence of Cushing's syndrome
* congenital adrenal hyperplasia (17-OH progesterone>10nmol/l)
* excessive androgens suspicious of a tumour
* prolactins levels >50μg/l
* previous breast, uterus, ovary or liver neoplasia
* use of medication known to affect glucose and lipid metabolisms (e.g. steroid hormones, oral contraceptives, ß-blockers, glitazones, statins, insulin)
* depo-medroxyprogesterone acetate injection in the last year
* important weight loss or weight gain within the last 6 months
* chronic, metabolic (except well controlled chronic hypothyroidism) or acute disease or major surgery within the last 3 months
* dietary incompatibility with calcium supplementation and/or fish consumption (allergy, intolerance, dislike)
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Study Objectives
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
Intervention / Treatment
DRUG: gemcitabine, DRUG: placebo, DRUG: Erlotinib, DRUG: apricoxib
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Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
* Life expectancy greater than or equal to 3 months.
* Patients must have measurable disease by RECIST.
* ECOG PS of 0, 1, or *
* Negative serum pregnancy test at the time of first dose for women of childbearing potential.
Exclusion Criteria:
* Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
* RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
* Evidence of New York Heart Association class III or greater cardiac disease.
* History of myocardial infarction, stroke, ventricular arrhythmia.
* Symptomatic central nervous system metastases.
* Pregnant or nursing women.
* Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
* History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
* Previous anti-EGFR kinase therapy.
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Study Objectives
This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib \[AG-013736\] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.
Intervention / Treatment
DRUG: Gemcitabine, DRUG: AG-013736, DRUG: Gemcitabine
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Inclusion Criteria:
* patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
* no prior therapy for metastatic disease
Exclusion Criteria:
* patients with locally advanced disease who are candidates for radiation therapy.
* uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)
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Study Objectives
This phase IIb trial studies how well alternative dosing of exemestane before surgery works in treating in postmenopausal patients with stage 0-II estrogen positive breast cancer. Chemoprevention is the use of drugs to keep breast cancer from forming or coming back. The use of exemestane may treat early stage (stage 0-II) breast cancer. Comparing the exemestane standard dose regimen versus two alternative, less frequent dose regimens may decrease undesirable symptoms and have similar efficacy in reducing serum estradiol.
Intervention / Treatment
DRUG: Exemestane, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, OTHER: Placebo Administration, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, PROCEDURE: Therapeutic Conventional Surgery
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Inclusion Criteria:
* Postmenopausal women (postmenopausal: age >= 60 years, or amenorrhea >= 12 months, or bilateral oophorectomy, or - in women with hysterectomy only - follicle stimulating hormone \[FSH\] in the menopausal levels as per local institutional guidelines if < 60 years old) with histologically-confirmed estrogen receptor (ER)-positive (>= 10%) primary breast cancer stage cT0-2, cN0-1, Mx; women with larger tumors who refuse chemotherapy (chemo) and/or endocrine neoadjuvant therapy can be eligible
* Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)
* Leukocytes >= 3,000/microliter
* Absolute neutrophil count >= 1,500/microliter
* Platelets >= 100,000/microliter
* Total bilirubin =< 2 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =< *5 x institutional ULN
* Serum creatinine =< *5 times institutional ULN
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Body mass index (BMI) < *5 Kg/m\^2
* Previous treatment for breast cancer including chemotherapy, endocrine therapy and radiotherapy; women with prior ductal breast carcinoma in situ (DCIS) who were treated with surgery only and whose treatment ended >= 2 years prior to enrollment are eligible for the trial
* Women who are planned to receive neoadjuvant therapy
* Participants may not be receiving investigational agents
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to exemestane
* 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
* Other co-existing invasive malignancies (with the exclusion of basal cell carcinoma or skin squamous cell carcinoma) diagnosed during the last 2 years before randomization
* History of severe osteoporosis (T score =< -4 either spine or hip), or presence of vertebral fracture
* Use of systemic hormone replacement therapy (HRT) in the last 30 days prior to the randomization; the use of non-systemic estrogen (such as vaginal estrogen use) is allowed
* Use of any chemopreventive agents (selective estrogen receptor modulators \[SERM\]) in the last 3 months
* Concomitant use of CYP3A4 inducer medication (rifampicin, phenytoin, carbamazepine, phenobarbital, and St. John's wort)
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Study Objectives
Sympathetic nerve activity can be measured transcutaneously in awake patients by computer-based filtering of raw signal obtained via skin leads attached on the chest. Electrocardiogram can be removed by applying a high-pass filter setting of 150 Hz. Electromyogram can be filtered by applying a high-pass filter setting of 500 Hz or a band-pass filter setting of 500-1000 Hz.
However, it is not known whether the skin sympathetic nerve activity (SKNA) can be measured in anesthetized and/or paralyzed patients. Therefore, we planned this pilot study to observe whether the SKNA can be obtained in these patients. If the SKNA ca be observed, it will be presented in milivolt (uV).
Intervention / Treatment
DRUG: Rocuronium
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Inclusion Criteria:
* patients scheduled to undergo resection of breast cancer under general anesthesia after insertion of laryngeal mask airway
Exclusion Criteria:
* Autonomic nervous system disease
* Medication acting on the autonomic nervous system
* Refuse to participate
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Study Objectives
The purpose of this study is to determine whether patients are able to participate in a so called prehabilitation program (prior to the beginning of cancer treatment) which includes (1) a supervised and home-based exercise program plus one educational session or (2) just home-based exercise plus one educational session or (3) just one educational session.
Breast cancer surgery may have potential for several side effects, including functional (e.g. flexibility in the affected arm, lymphedema \[swelling that generally occurs in the arms or legs that occurs as a result of the removal of or damage to lymph nodes as a part of cancer treatment\], shoulder pain) and psychosocial (e.g. reduced quality of life, increased fatigue) aspects.
Evidence shows that exercise is considered to be an effective treatment approach in breast cancer patients during and after treatment with regard to the above mentioned side-effects. Also, prehabilitative exercise in colon and lung cancer patients was shown as feasible and effective. However, no experience exits with regard to prehabilitation exercise in breast cancer patients.
Intervention / Treatment
BEHAVIORAL: Exercise, BEHAVIORAL: Prehabilitation Education
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Inclusion Criteria:
* Unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy
* Not metastatic (stage <4)
* Females and males ≥18 years of age
* Fluent in written and spoken English
* Must be able to provide and understand informed consent
* Must have an ECOG PS of ≤ 2
* Scheduled for lump- or mastectomy at Penn State Cancer Institute
* ≥ 2 weeks till primary treatment
* Primary attending surgeon approval
Exclusion Criteria:
* Receiving neoadjuvant chemotherapy, radiotherapy or hormone therapy
* Not fluent in written and spoken English
* Evidence in the medical record of an absolute contraindication (e.g. Heart insufficiency > NYHA III or uncertain arrhythmia; uncontrolled hypertension; severe renal dysfunction (GFR < 30%, Creatinine> 3mg/dl; insufficient hematological capacity like either hemoglobin value below 8 g/dl or thrombocytes below *000/µL; reduced standing or walking ability) for exercise
* Pregnant women
* Engaging in systematic intense exercise training (at least 1h twice per week)
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Study Objectives
This study evaluated the pharmacokinetics of aldesleukin in participants with metastatic renal cell cancer or metastatic melanoma.
Intervention / Treatment
DRUG: Aldesleukin
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Inclusion criteria:
* Performance Status Eastern Cooperative Oncology Group: 0 or *
* Adequate organ function.
Exclusion criteria:
* Pregnancy or lactation.
* Prior treatment with any form of IL-*
* Organ transplant. Other protocol-defined inclusion/exclusion criteria may apply
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Study Objectives
To understand the epidemiology, treatment patterns and outcomes of patients with metastatic Renal Cell Carcinoma (mRCC). Data from mRCC patients who received cabozantinib versus non-cabozantinib Tyrosine Kinase Inhibitor (TKI) (a type of targeted cancer drug) immediately after Check Point Inhibitor (CPI) treatment (a type of immunotherapy that blocks proteins that stop the immune system from attacking the cancer cells) in US community oncology practices will be analyzed.
Intervention / Treatment
DRUG: Cabozantinib monotherapy, DRUG: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC
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Inclusion Criteria:
* Evidence of metastatic Renal Cell Carcinoma (mRCC) during the study period (May 01, 2016 to March 31, 2020);
* Patients who received cabozantinib or non-cabozantinib TKI regimens during identification period (May 01, 2016 to September 30, 2019);
* Patients who received CPIs, as monotherapy, or in combination with a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor (e.g. ipilimumab+nivolumab), as the latest treatment for mRCC administrated before cabozantinib or other TKI therapy;
* Patients ≥ 18 years of age as of their index date
* Patients who received care at a US Oncology Network site
* Patients with ≥ 2 visits within the US Oncology Network.
Exclusion Criteria:
* Patients enrolled in a clinical trial at any time during index period
* Patients receiving treatment for another documented primary cancer diagnoses during the study period
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Study Objectives
This clinical trial will evaluate the safety and immune response of the sequential administration cancer vaccine CRS-207 (with or without cyclophosphamide) followed by standard of care chemotherapy (pemetrexed and cisplatin). CRS-207 is a weakened (attenuated) form of Listeria monocytogenes that has been genetically-modified to reduce its capacity to cause disease, while maintaining its ability to stimulate potent immune responses. CRS-207 has been engineered to elicit an immune response against the tumor-associated antigen mesothelin, which has been shown to be present at higher levels on certain tumor cells (such as mesothelioma) than on normal cells. Pemetrexed and cisplatin are the standard chemotherapy regimen to treat malignant pleural mesothelioma. This trial will evaluate whether giving CRS-207 cancer vaccine with chemotherapy will induce anti-tumor immune responses and/or objective tumor response.
Intervention / Treatment
BIOLOGICAL: Immunotherapy plus chemotherapy, BIOLOGICAL: Immunotherapy with cyclophosphamide plus chemotherapy
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Inclusion Criteria:
* Have histologically confirmed epithelial or biphasic MPM not amenable to potentially curative surgical resection (subjects with biphasic tumors that have a predominantly (≥50%) sarcomatoid component will be excluded)
* Be at least 18 years of age
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Have an anticipated life expectancy of greater than 6 months
* For women and men of childbearing potential, a medically acceptable method of highly effective contraception (oral hormonal contraceptive, condom plus spermicide, or hormone implants) must be used throughout the study period and for 28 days after their final vaccine administration. (A barrier method of contraception must be employed by all subjects \[male and female\], regardless of other methods.)
* Be willing and able to give written informed consent, and be able to comply with all study procedures
* Have adequate organ function as defined by specified laboratory values
Exclusion Criteria:
* A candidate for curative surgery
* Surgery within 2 weeks prior to dosing
* Prior radiotherapy or biologic therapy
* Treatment with an investigational agent within 4 weeks before dosing
* Prior systemic chemotherapy
* Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
* Documented and ongoing brain metastases
* Have any evidence of hepatic cirrhosis or clinical or radiographic ascites
* Have clinically significant and/or malignant pleural effusion
* Known or suspected allergy or hypersensitivity to yeast or any other component of CRS-207 (e.g., glycerol), Platinol or platinum-containing compounds, or pemetrexed
* Used any systemic steroids within 28 days of study treatment
* Use more than 3 g/d of acetaminophen
* An artificial (prosthetic) joint or other artificial implant or device that cannot be easily removed (with some exceptions for dental and breast implants and biliary stents and mediports)
* Infection with HIV or hepatitis B or C at screening
* Any immunodeficiency disease or immunocompromised state or active autoimmune disease or history of autoimmune disease requiring systemic steroids or other immunosuppressive treatment
* Be a woman who is pregnant or breastfeeding
* Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen
* Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
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Study Objectives
The purpose of this study is to examine the safety and evaluate the response of VB-111 on DTC.
Intervention / Treatment
DRUG: VB-111
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Inclusion Criteria:
* Histologically or cytologically confirmed advanced DTC (papillary, follicular, Hurthle cell);
* Absence of sensitivity to therapeutic radioiodine;
* Measurable disease, defined as at least one non-bony lesion that can be accurately measured in at least one dimension as confirmed with spiral CT scan
* Life expectancy >3 months; ECOG performance status (PS) 0, 1, or 2; Karnofsky performance status of ≥60%;
* Subjects with a normal/acceptable hematological profile
* Subjects with adequate renal function
Exclusion Criteria:
* Presence of any of the following:
* Radiotherapy or chemotherapy <4 weeks prior to baseline visit; (Concurrent and/or prior therapy with octreotide will be allowed, provided tumor progression on this therapy has been demonstrated; Concurrent and/or prior therapy with biphosphonates will be allowed)
* Radiotherapy to ≥25% of bone marrow;
* Major surgery <4 weeks prior to baseline visit;
* Any other ongoing investigational agents within 4 weeks before dosing;
* Subjects who suffered from an acute cardiac event within the last 12 months, including myocardial infarction, cardiac arrythmia, admission for unstable angina, cardiac angioplasty, or stenting;
* QTc prolongation (defined as QTc interval ≥500 msecs) or other significant ECG abnormalities (e.g. frequent ventricular ectopy, evidence of ongoing myocardial ischemia);
* Subjects with active vascular disease, either myocardial or peripheral;
* Subjects with proliferative and/or vascular retinopathy;
* Subjects with known active liver disease (alcoholic, drug/toxin induced, genetic, or autoimmune) other than related to tumor metastases;
* Subjects with known CNS metastatic disease (Exception: Subjects with treated CNS metastases stable by radiographic examinations >6 months after definitive therapy administered, are eligible);
* Subjects testing positive to one of the following viruses: HIV, HBV or HCV;
* Any of the following conditions:
* Serious or non-healing wound, ulcer, or bone fracture;
* History of abdominal fistula, gastro-intestinal perforation, active diverticulitis, intra-abdominal abscess or gastro-intestinal tract bleeding within 6 months of dosing;
* Any history of cerebrovascular accident (CVA) within 6 months of dosing;
* Current use of therapeutic warfarin (Note: Low molecular weight heparin and prophylactic low-dose warfarin \[INR<*2 X ULN\] are permitted);
* History of bleeding disorder, including subjects with hemophilia, disseminated intravascular coagulation (DIC), or any other abnormality of coagulation potentially predisposing subjects to bleeding;
* Poorly controlled depression or anxiety disorder, or recent (within the previous 6 months) suicidal ideation;
* Subjects with an ongoing requirement for immunosuppressive treatment, including the use of glucocorticoids or cyclosporin, or with a history of chronic use of any such medication within the last 4 weeks before dosing;
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
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Study Objectives
A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.
Intervention / Treatment
PROCEDURE: 6-minute then 9-minute withdrawal, PROCEDURE: 9-minute then 6-minute withdrawal
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Inclusion Criteria:
* Patients whose age is between 40-*
* Patients who have indications for screening
* Patients who have signed inform consent form.
Exclusion Criteria:
* Patients who have undergone colonic resection or polypectomy
* Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
* Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days
* Patients with inflammatory bowel diseases
* Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests
* Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
* Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
* Patients with failed cecal intubation
* Patients with poor BPQ that necessitated a second bowel preparation
* Patients with therapeutic colonoscopy for existing lesions
* Patients refusing to participate or to provide informed consent
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Study Objectives
Sorafenib may stop the growth of tumor cells by stopping blood flow to the tumor and by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving sorafenib with gemcitabine may kill more tumor cells. This phase II trial is studying how well giving sorafenib together with gemcitabine works in treating patients with locally advanced or metastatic pancreatic cancer.
Intervention / Treatment
DRUG: sorafenib tosylate, DRUG: gemcitabine hydrochloride
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Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas
* Locally advanced or metastatic disease
* Locally advanced disease must extend outside the boundaries of a standard radiotherapy port
* Not amenable to curative surgery or radiotherapy
* Measurable disease
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Pleural effusion and ascites are not considered measurable lesions
* Outside prior radiotherapy port
* No known brain metastases
* Performance status - ECOG 0-1
* Performance status - Karnofsky 70-100%
* More than 3 months
* WBC ≥ 3,000/mm\^3
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No evidence of bleeding diathesis
* Bilirubin normal
* AST and/or ALT ≤ *5 times upper limit of normal
* Creatinine normal
* Creatinine clearance ≥ 60 mL/min
* No uncontrolled hypertension
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active or ongoing infection
* No other active malignancy
* No history of allergic reaction attributed to compounds of similar chemical or biological composition to sorafenib or other study agents
* No psychiatric illness or social situation that would preclude study compliance
* No other uncontrolled illness
* No prior antiangiogenic agents
* No prior cytotoxic chemotherapy for metastatic disease
* At least 4 weeks since prior adjuvant chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No prior gemcitabine
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* No prior investigational drugs
* No prior sorafenib
* No prior MAPK signaling agents
* Concurrent warfarin anticoagulation allowed provided the following criteria are met:
* Therapeutic on a stable warfarin dose
* INR ≤ 3
* Undergo weekly INR testing
* No active bleeding or pathological condition that carries a high risk of bleeding
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents
* No other concurrent anticancer therapies
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Study Objectives
The primary objective of the study is to determine the maximum tolerated dose (MTD) of blinatumomab in combination with pembrolizumab in adults with relapsed or refractory (r/r) DLBCL.
Intervention / Treatment
DRUG: Blinatumomab, DRUG: Pembrolizumab
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Inclusion Criteria:
* Have histologically confirmed diffuse large B-cell lymphoma that is either:
* Refractory after at least one regimen of systemic chemotherapy and/or targeted therapy, or
* In first or later relapse if have received at least 2 systemic regimens since time of diagnosis, or
* Relapsed post-autologous or allogeneic hematopoietic stem cell transplantation (HSCT) with adequate organ function after proximity to transplantation time exclusions
* Have measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Life expectancy of ≥ 12 weeks in the opinion of the Investigator
* Biopsy proven DLBCL (biopsy proven at least at primary diagnosis of DLBCL)
Other Inclusion Criteria May Apply
Exclusion Criteria:
* Richter's transformation (DLBCL arising in the setting of prior chronic lymphocytic leukemia) or primary mediastinal B cell lymphoma (PMBCL)
* History or presence of clinically relevant central nervous system pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
* Has a diagnosis of immunodeficiency or has received systemic steroid therapy (in excess of 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol specified therapy.
* Has undergone prior allogeneic HSCT:
* within the last 5 years OR
* greater than 5 years ago but has active graft versus host disease (GvHD) requiring systemic treatment.
* Has received autologous HSCT within 6 weeks prior to start of treatment.
Other Exclusion Criteria May Apply.
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Study Objectives
The Whipple procedure is associated with increased readmission rates for infection, pancreatic leak, and failure to thrive/malnutrition. The purpose of this study is to develop an evidence based perioperative nutrition plan to improve patient outcomes. The study has two specific aims including evaluation of feasibility of implementing an evidence based perioperative nutritional plan for patients undergoing Whipple and evaluation of impact of a standard perioperative nutritional plan on primary outcome of readmission rate and secondary outcomes of readmission cause, length of stay for initial hospitalization and/or readmission, post surgical complications (surgical site infections, pancreatic leak, sepsis, delayed gastric emptying), and nutritional status (PG-Subject Generated Assessment scores, BMI, albumin, pre-albumin, and method of oral intake). Categorical variables including readmission rate, readmission cause, post-surgical complications and nutritional status will be compared by chi-square test between intervention and control group. Length of stay for initial hospitalization and readmission will be compared by non parametric Wilcoxon test between two groups. Descriptive statistics will be used to describe the sample. There are no risks to the study participants.
Intervention / Treatment
DIETARY_SUPPLEMENT: Nestle Impact Advanced Recovery nutritional supplement
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Inclusion Criteria:
* Adult patients (>18 years of age)at Duke Cancer Center
* Malignant pancreatic disease, undergoing surgical resection with pancreaticoduodenectomy (Whipple)
* Able to read and speak English.
Exclusion Criteria:
* Patients receiving preoperative enteral nutrition
* Inability to tolerate preoperative oral intake
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Study Objectives
Phase I trial to study the effectiveness of combining erlotinib with radiation therapy with or without cisplatin in treating patients who have advanced mouth or throat cancer. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining erlotinib with radiation therapy with or without cisplatin may kill more tumor cells.
Intervention / Treatment
DRUG: erlotinib hydrochloride, DRUG: cisplatin, RADIATION: intensity-modulated radiation therapy, OTHER: laboratory biomarker analysis
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Inclusion Criteria:
* Patients with clinical findings consistent with a diagnosis of squamous cell carcinoma of the OC or OP, as determined by the head and neck surgeon, may be recruited to the study prior to diagnostic biopsy; patients must have a histologically confirmed diagnosis of squamous cell carcinoma of OC or OP prior to proceeding with treatment
* Oropharyngeal sites include base of tongue, tonsil, soft palate, and oropharyngeal wall
* Oral cavity sites include oral tongue, buccal mucosa, floor of mouth, retromolar trigone, alveolar ridge, hard palate and mucosal lip
* Patients must be AJCC stage II (T2N0) or III (T1-2N1) (AJCC fifth edition, 1997) for part A of the study, and must be AJCC stage III (T3N 0-1) or IV (T1-4N2-3M0, T4N0-1M0) for part B of the study
* Priority for study entry will be given to patients with easily accessible tumor and who consent to repeat biopsy; study entry will not be restricted to patients who agree to further biopsies; if a patient enrolls on study and later refuses biopsy (excluding diagnostic), he/she may remain on study
* Patients with operable or inoperable tumors will be eligible
* No prior therapy for the tumor, including chemotherapy, radiation therapy, immunotherapy, EGFR targeted therapies, or any other investigational agents
* Prior malignancies of sites other than the head and neck are allowed if disease free interval >= 3 years; basal cell carcinomas of the skin and in situ cervical dysphagias are allowed within this three year interval if completely resected
* Documentation of evaluable tumor less than or equal to four weeks before treatment start
* ECOG performance status = 0, 1 or 2 (Karnofsky >= 60%)
* Life expectancy of greater than or equal to 6 months
* Leukocytes >= 3,000
* Absolute neutrophil count >= 1,500
* Platelets >= 100,000
* Total bilirubin within normal institutional limits unless due to hemolysis or Gilbert's syndrome
* AST(SGOT)/ALT(SGPT) =< *5 X institutional upper limit of normal
* Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/*73 m\^2 for patients with creatinine levels above institutional normal
* APTT/INR within normal institutional limits; patients who have abnormalities in APTT/INR that are correctable after administration of vitamin K are eligible
* No uncontrolled diabetes mellitus as glucose must be within a consistently normal range for each patient in order to standardize PET scan interpretations
* No known malabsorption syndrome
* G-tube dependent patients are eligible
* The effects of OSI-774 on the developing human fetus at the recommended therapeutic dose are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Patients with known brain involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to OSI-774 or other agents used in study
* Major surgery or significant traumatic injury occurring within 28 days prior to treatment
* Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjögren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
* Gastrointestinal tract disease resulting in an inability to take oral or enteral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, untreated or new cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Pregnant women are excluded from this study because OSI-774 is an epidermal growth factor inhibitor with the potential for teratogenic or abortifacient effects based on the data suggesting that EGFR expression is important for normal organ development; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with OSI-774, breastfeeding should be discontinued if the mother is treated with OSI-774
* Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with OSI-774; appropriate studies will be undertaken in patients receiving combination anti-retroviral therapy when indicated
* Patients on Coumadin are excluded from the study because of reports of interactions between the study drug and Coumadin
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Study Objectives
The purpose of this study is to determine the efficacy and safety of bevacizumab/capecitabine/oxaliplatin combination in metastatic or recurrent Korean colorectal cancer.
Intervention / Treatment
DRUG: Bevacizumab
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Inclusion Criteria:
* Histologically or cytologically documented colorectal adenocarcinoma
* ECOG performance status of 2 or lower
* Adequate bone marrow function
* Adequate kidney function
* Adequate liver function
* Informed consent
Exclusion Criteria:
* Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start
* Known allergy to study drugs
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Study Objectives
The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.
Intervention / Treatment
DRUG: Sequential Gefitinib With Pemetrexed/Platinum, DRUG: Pemetrexed/Platinum
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Inclusion Criteria:
* 18\~70 years
* Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
* Presence of at least one index lesion measurable by CT scan or MRI
* Ecog0-1
* Expected life time longer than 12 weeks
* Normal laboratory values:
* leucocyte ≥ 4×109/L
* neutrophil ≥ *5×109/L
* platelet ≥ 100×109/L
* Hemoglobin ≥ 10g/L
* ALT and
* AST ≤ *5×ULN (≤ 5×ULN if liver metastasis)
* Signed written informed consent
Exclusion Criteria:
* Patients have used drugs according to protocol
* Patients were allergic to pemetrexed or cisplatin
* Patients received radiotherapy or other biological treatment 4 weeks before the trial
* Uncontrolled hydrothorax or hydropericardium
* neuropathy toxicity ≥ CTC 3
* Severe symptomatic heart disease
* Active upper gastrointestinal ulcer or digestive disfunction
* Severe infection or metabolic disfunction
* Patients with other malignant tumor
* Uncontrolled brain metastases
* Patients have accepted other clinical trials
* Female patients during their pregnant and lactation period, or patients without contraception
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Study Objectives
This phase II trial is studying the side effects and how well giving alvocidib together with cytarabine and mitoxantrone works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as alvocidib, cytarabine, and mitoxantrone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.
Intervention / Treatment
DRUG: alvocidib, DRUG: cytarabine, DRUG: mitoxantrone hydrochloride
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Inclusion Criteria:
* Adults with established, pathologically confirmed diagnoses of newly diagnosed, poor-risk Acute Myeloid Leukemia(AML) including de novo and secondary Acute Myeloid Leukemias but excluding newly diagnosed acute progranulocytic leukemia (APL, M3) will be considered eligible for study
* ECOG performance status 0-2
* Patient must be able to give informed consent
* Serum creatinine =< *0
* ALT, AST =< 5 x upper limit of normal
* Bilirubin =< *0 mg/dl
* Left ventricular ejection fraction >= 45%
* Newly diagnosed AML, subtypes M0,1,2,4-7 but excluding M3 (APL) with poor-risk features, including:
* Age > 50 years, or age > 18 years with one or more of the following criteria:
* Antecedent hematologic disorder including myelodysplasia (MDS)-related AML (MDS/AML) and prior myeloproliferative disorder (MPD)
* Treatment-related AML
* AML with trilineage dysplasia (AML-TLD)
* Adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q or 17p; t(6;9); t(9;22); trisomy 8; trisomy 13, complex karyotypes (>= 3 unrelated abnormalities)
Exclusion Criteria:
* Patients who have received hydroxyurea alone or have received non-cytotoxic therapies previously for MDS or MPD (e.g., thalidomide or lenalidomide, interferon, cytokines, low-dose 5-azacytidine, low-dose cytoxan) will be eligible for this trial
* Any previous treatment with flavopiridol
* Concomitant chemotherapy, radiation therapy, or immunotherapy
* Hyperleukocytosis with >= 50,000 blasts/uL; leukapheresis or hydroxyurea may be used immediately prior to study drug administration for cytoreduction; must be stopped 24 hours before first dose of Flavopiridol
* Acute Progranulocytic Leukemia (APL, M3)
* Active CNS leukemia
* Active, uncontrolled infection; patients with infection under active treatment and controlled with antibiotics are eligible
* Presence of other life-threatening illness
* Patients with mental deficits and/or psychiatric history that preclude them form giving informed consent or from following protocol
* Pregnant and nursing patients are excluded
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Study Objectives
This study aims to evaluate if BioXmark™, a surgical marker, may efficiently and safely be used to preoperatively mark the proximal and distal resection line 5 cm proximal and distal to the tumor margin of gastroesophageal-junction adenocarcinoma (GEJ AC).
Furthermore, to determine if placing the resection margin according to the resection margin defined by BioXmark™ is superior to the current standard of a proximal resection line estimation by the individual surgeon based on the intraoperative findings.
Intervention / Treatment
OTHER: BioXmark™
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Inclusion Criteria:
* Patients referred with gastroesophageal adenocarcinoma to the Department of Surgery \& Transplantation, Centre of Cancer and Organ Diseases, Rigshospitalet, and who are candidates for curatively intended surgery.
Exclusion Criteria:
* Patients under the age of *
* Patients diagnosed with disseminated disease during surgery.
* Patients with impaired cognitive ability, making obtainment of informed consent impossible
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Study Objectives
Colorectal cancer (CRC) is the second most common cancer and the fourth leading cause of cancer death in Korea. Colonoscopy with polypectomy decreases the incidence and mortality from colorectal cancer. However, significant lesions can be missed during colonoscopy. Recent retrospective studies have shown that fellow involvement as a second observer may increase adenoma detection rate in colonoscopy.
The aim of this prospective, multicenter, randomized study is to evaluate the impact when endoscopy nurse participate in adenoma detection during screening colonoscopy. The primary outcome measure is the adenoma detection rate (ADR).
Intervention / Treatment
PROCEDURE: standard of care colonoscopy, PROCEDURE: standard of care colonoscopy
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Inclusion Criteria:
* age over 50
* screening colonoscopy
Exclusion Criteria:
* History of colorectal surgery
* History of hereditary colorectal cancers or polyposis syndrome
* Gastrointestinal bleeding
* Inflammatory bowel diseases
* Inability to provide informed consent
* Pregnancy
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Study Objectives
This Phase 1b/2 study is designed to assess the safety and efficacy of ibrutinib in combination with lenalidomide and rituximab in subjects with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not eligible for transplant.
Intervention / Treatment
DRUG: Ibrutinib, DRUG: Lenalidomide, DRUG: Rituximab
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Inclusion Criteria:
* Pathologically confirmed relapsed/ refractory DLBCL
* Must have previously received first line treatment regimen
* Must be ineligible for high dose therapy/ stem cell transplantation
* Measurable disease sites on computed tomography (CT) scan (>*5 cm in longest dimension)
* prothrombin time/international normalized ratio (PT/INR) < *5 x upper limit of normal (ULN) and partial thromboplastin time (PTT; activated partial thromboplastin time \[aPTT\]) <*5 x ULN
* Men and women ≥18 years of age
* Eastern Cooperative Oncology Group (ECOG) < 2
* Adequate hepatic and renal function
* Adequate hematologic function
Exclusion Criteria:
* Medically apparent central nervous system lymphoma or leptomeningeal disease
* History of allogeneic stem-cell (or other organ) transplantation
* Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
* Radio- or toxin-immunoconjugates within 10 weeks
* Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
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Study Objectives
The purpose of this study is to confirm the safety profile such as the frequency of serious adverse events or any unexpected adverse events and overall efficacy of Faslodex for long term treatment in daily clinical practice.
Intervention / Treatment
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Inclusion Criteria:
* Patients treated with Faslodex for the first time due to postmenopausal breast cancer
Exclusion Criteria:
* None
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Study Objectives
To figure out whethetr 18F-FES PET/CT could influence the staging and management of newly diagnosed Oestrogen Receptor-positive Breast Cancer Patients.
Intervention / Treatment
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Inclusion Criteria:
* Patients with newly diagnosed immunohistochemical confirmed oestrogen receptor (ER)-positive breast cancer
* Patients underwent both 18F-FES PET/CT and 18F-FDG PET/CT in Fudan University Shanghai Cancer Center within 1 week after diagnosis
* Patients with available medical history
Exclusion Criteria:
* Patients with incomplete medical history
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Study Objectives
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
Intervention / Treatment
DEVICE: MammoSite Radiation Therapy System
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Inclusion Criteria:
* Pre-Surgery:
* Unicentric pure DCIS
* Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI
* Post-Surgery:
* Negative histological margins confirmed prior to beginning radiation therapy.
* Margins are positive if there is tumor at the inked margin.
* Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible
* Clinically node negative
Exclusion Criteria:
* Distance from the balloon surface to the surface of the skin < 5mm as determined by CT imaging.
* Distant metastases.
* Invasive or in-situ lobular carcinoma (post-surgery assessment).
* Nonepithelial breast malignancies such as sarcoma or lymphoma.
* DCIS that is multicentric in the ipsilateral breast.
* Pregnant or lactating.
* Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
* Collagen vascular diseases
* Coexisting medical conditions with life expectancy < 2 years.
* Serious psychiatric or addictive disorder
* Previously treated contralateral breast carcinoma
* Synchronous bilateral breast carcinoma.
* Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous.
* Patients with diffuse disease
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Study Objectives
Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 7000 children aged \<21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).
Intervention / Treatment
DRUG: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
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Inclusion Criteria:
* 1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver
Exclusion Criteria:
* 1) Failure to obtain consent/assent (as indicated)
* 2) Known pregnancy as determined via interview or testing if available.
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Study Objectives
At this point in the treatment of extensive stage SCLC, we have reached a plateau in survival with conventional chemotherapy and newer regimens are greatly needed. It has been noted that patients with increased VEGF levels have a poorer prognosis. Anti-angiogenic agents hold significant promise in the treatment of patients with extensive stage SCLC. ZD6474, a new inhibitor of the VEGFR-2, has shown favorable action in NSCLC.
Intervention / Treatment
DRUG: Cisplatin, DRUG: Etoposide, DRUG: Placebo, DRUG: ZD6474
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Inclusion Criteria:
* Histological or cytological proof of chemotherapy-naïve, extensive, small cell lung cancer.
* Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy.
* Written informed consent and HIPAA authorization for release of personal health information.
* Age 18 years or older at the time of consent.
* Potassium ≥*0 mmol/L and <*5mmol/L (supplementation is allowed).
* Calcium within normal range (supplementation is allowed).
* Magnesium within normal range (supplementation is allowed).
Exclusion Criteria:
* No prior EGFR inhibitor or antiangiogenic agent allowed.
* No prior hormonal therapy.
* No symptomatic brain metastasis.
* No clinically significant infections as judged by the treating investigator.
* No evidence of severe or uncontrolled other systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.
* No previous history of QTc prolongation as a result of medication that required discontinuation of that medication.
* No congenital long QT syndrome or known 1st degree relative with unexplained sudden death under 40 years of age.
* No presence of left bundle branch block (LBBB.)
* No QTc with Bazett's correction that is unmeasurable, or ≥480 msec on screening ECG obtained within 7 days prior to registration for protocol therapy. If a subject has QTc ≥480 msec on screening ECG, the screen ECG may be repeated twice (at least 24 hours apart). The average QTc from the three screening ECGs must be <480 msec in order for the subject to be eligible for the study.
* No concomitant (within 14 days prior to registration for and during protocol therapy) medication associated with Torsades de Pointes or cause QTc prolongation, is allowed. Medications that prolong QT, but are not strictly associated with Torsades, are allowed if medically necessary and will require increased ECG and electrolyte monitoring.
* No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg).
* No currently active diarrhea that may affect the ability to absorb ZD*
* No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason < grade 7 prostate cancers, or other cancer for which the subject has been disease-free for at least 5 years.
* Major surgery must be completed greater than 28 days prior to registration for protocol therapy and healed surgical incision is required.
* No concomitant (within 14 days prior to registration for and during protocol therapy) medications that are potent inducers (rifampicin, rifabutin, phenytoin, carbamazepine, phenobarbital and St. John's Wort) of CYP3A4 function.
* Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 8 weeks after treatment discontinuation.
* Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
* Females must not be breastfeeding.
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Study Objectives
The trial was designed to compare the effectiveness of radical resections of lung cancer plus adjuvant chemotherapies and perioperative chemotherapies in the patients with N2 non-small cell lung cancer
Intervention / Treatment
PROCEDURE: Surgeries
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Inclusion Criteria:
* Patients with radical resection of lung cancer enrolled from 2014 to 2019;
* Pathologically diagnosed patients with non-small cell lung cancer;
* Patients with age > 18 years old;
* Patients who did not receive chest surgeries before hospitalization;
* Patients with N2 lymph nodes (+) after surgeries;
* Patients who received lymphadenectomy for one group or more groups of lymph nodes;
Exclusion Criteria:
* Patients with second primary tumors or multiple primary tumors;
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Study Objectives
The goals of the study are to investigate the needs of older (age 60+) caregivers caring for adults with cancer at 1-week and 2 weeks following hospital discharge and to explore strategies that may assist caregivers in their home caregiving needs. This study will explore how these needs vary based on caregiver spirituality and relationship with the care recipient.
The study will enroll cancer patients and their caregivers admitted to 9100 and 9300, which are the hematological and non-hematological malignancy units at Duke University Medical Center (DUMC) respectively. Results of this study will lay the groundwork for creating tailored interventions for caregivers that are compatible to their preferences and more responsive to their needs.
Intervention / Treatment
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Inclusion Criteria:
* Caregiver must speak English
* Caregiver must be at least 60 years of age
* Patients must be 18 years of age or older \& speak English
* Patients must have been admitted to either the 9100 or 9300 oncology unit for treatment of cancer, or treatment-related/cancer-related complications
* Patients must be discharged home to participate in the study
Exclusion Criteria:
* Dyads who received hospice referral prior to the care recipient's discharge
* Patient must not have any diagnosis of dementia in their medical records, or any cognitive impairment as assessed by hospital providers (physicians and nurses)
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Study Objectives
The primary objective of this study is to compare disease-free survival (DFS) of patients with triple negative breast cancer randomised to treatment with standard adjuvant chemotherapy alone or to standard adjuvant chemotherapy followed by 1 year of Capecitabine (Xeloda) metronomic therapy.
Intervention / Treatment
DRUG: Capecitabine
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Inclusion Criteria:
* Patients must be >=18 years of age;
* The patients must be Operable primary invasive breast cancer;
* Definitive loco-regional surgery must be completed;
* Primary tumor centrally confirmed as triple negative;
* Operable node-positive (or node-negative with tumor diameter ≥ *5cm);
* Chest, abdominal, bone imaging performed with 3 months prior to randomization must not reveal the presence of distant spread;
* There are normal organ function, including bone marrow function, renal function, liver function, and cardiac function;
* All patients must have signed and dated an informed consent form.
Exclusion Criteria:
* Patients with bilateral breast cancer, inflammatory carcinomas;
* Patients with positive supraclavicular or internal mammary lymph node;
* Previous breast cancer history;
* Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin;
* Pregnant or breast-feeding women;
* Women who are unwilling to agree to use an effective non-hormonal method of contraception during the treatment period of Xeloda;
* Any sex hormonal therapy;
* Malabsorption syndrome.
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Study Objectives
Prospective, multicenter, observational registry of myeloma patients undergoing hematopoietic progenitor cell mobilization for upfront autologous transplantation.
Intervention / Treatment
PROCEDURE: Autologous hematopoietic cell transplant
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Inclusion Criteria:
* Myeloma patients ages 18-70 years.
* Undergoing upfront autoHCT (≤12 months from start of initial therapy for myeloma).
Exclusion Criteria:
* Patients with light chain (AL) amyloidosis or myeloma with associated AL amyloidosis.
* POEMS syndrome
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Study Objectives
This is a single arm, open-label, non-randomized, dose-escalation, phase I study to determine the safety and efficacy of CNCT19 in adult patients with relapsed or refractory diffuse Non-Hodgkin lymphoma.
Intervention / Treatment
BIOLOGICAL: single dose of CNCT19
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Inclusion criteria:
* Informed consent is signed by the subject.
* Age 18 to *
* Relapsed or refractory NHL with CD19-positive after at least two systemic lines of therapy
a. Diffuse large B cell lymphoma (DLBCL) non-specific (NOS), T-cell / Histiocyte Rich large B-cell lymphoma, elderly EBV-positive diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), chronic inflammation-associated DLBCL, follicular lymphoma (FL) transformed large B-cell lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and / or BCL6 rearrangement and High-grade B-cell lymphoma-unspecified; b. Chemotherapy-refractory disease, defined as one of more of the following:
* No response to last line of therapy; i. Progressive disease (PD) as best response to most recent therapy regimen; ii. Stable disease (SD) as best response to at least 4 courses of first-line treatment / at least 2 courses of end-line treatment (2 lines and above) with duration no longer than 6 month from last dose of therapy OR;
* Refractory post-autologous stem cell transplant (ASCT); i. Disease progression or relapsed less than or equal to 12 months of ASCT (must have biopsy proven recurrence in relapsed individuals); ii. If salvage therapy is given post-ASCT, the individual must have had no response to or relapsed after the last line of therapy; Any BM relapse after autologous stem cell transplantation (ASCT); c. Individuals must have received two systemic lines of therapy
* anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20-negative;
* an anthracycline containing chemotherapy regimen;
* FL-transformed DLBCL must have received pre-chemotherapy for FL and become resistant after conversion to DLBCL.
* At least one measurable lesion, defined as at least 1 lymph node >*5 cm in the longest diameter, per revised IWG Response Criteria.
* Any previous systemic immune checkpoint therapy (such as anti-PD1 / PD-L1 monoclonal antibody, etc.), at least 3 half-lives away from the Cell Product Preparation; other systemic treatments should be stoped at least 2 weeks or 5 half-lives before Cell Product Preparation (shorter Whichever comes first).
* Eastern cooperative oncology group (ECOG) performance status of 0 to *
* Sufficient bone marrow reserves defined as:
* Absolute neutrophil (ANC) > 1,000 / mm3;
* Lymphocyte absolute value (ALC) ≥ 100 / mm3;
* Platelet (PLT) ≥ 50,000 / mm*
* Adequate organ function defined as:
* aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN);
* Serum alanine aminotransferase (ALT) ≤ 3 upper limit of normal (ULN);
* Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome; Note: Patients with Gilbert's syndrome that bilirubin ≤ 3 ULN and direct bilirubin ≤ *5 ULN will be eligible;
* A serum creatinine≤ *5 ULN or Creatine removal rate ≥ 60mL/min (Cockcroft and Gault);
* Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation > 91% on room air;
* International normalized ratio (INR) ≤ *5 ULN and activated partial thromboplastin time (APTT) ≤ *5 ULN;
* Non-hematological toxic reactions (excluding diseases related) caused by previous treatment were restored to ≤ 1 level before screening (excluding ≤ 2 level of neurotoxicity caused by hair loss and chemotherapy drugs).
* Women of childbearing age have a negative blood / urine pregnancy test within 7 days before the CNCT19 infusion. Women of child-bearing potential and all male participants must use highly effective methods of contraception throughout the study and for a period of at least six months after the CNCT19 infusion.
Exclusion criteria:
* Active CNS involvement by malignancy.
* Patients who received chemotherapy within 2 weeks before CNCT19 infusion. The following situations are excluded:
* Lymphodepleting Chemotherapy prescribed by the protocol;
* CNS prophylaxis treatment must be stopped > 1 week prior to CNCT19 infusion.
* Has had treatment with any prior anti-CD19 therapy.
* Plans to receive autologous stem cell transplantation (ASCT) within 6 weeks before the CNCT19 infusion.
* Patients who have previously received Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT).
* Patients with systemic vasculitis (such as Wegener granulomatosis, nodular polyarteritis, systemic lupus erythematosus) and active or uncontrolled autoimmune disease (such as autoimmune hemolytic anemia, etc.).
* Patients who are positive for any of HBsAg, HCV-Ab, TP-Ab.
* Patients who have previously received surgery within 4 weeks before the screening that was unsuitable for enrollment by the investigator's assessment.
* Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease. Patients with Prior malignancy that has been cured for ≥ 2 years are excluded.
* a. Left Ventricular Ejection Fraction (LVEF) ≤45%; b. III/IV congestive heart failure (NYHA); c. Severe arrhythmia (except for Atrial fibrillation, Paroxysmal supraventricular tachycardia); d. QTc≥450ms (male)or QTc≥470ms (female)(QTcB=QT/RR1/2); e. Myocardial infarction or Coronary Artery Bypass Graft Surgery, heart stent surgery < 6 months prior to CNCT19 infusion; f. Clinically significant valvular disease; g. Other heart diseases that have been judged by the investigator to be unsuitable for receiving cell therapy.
* Clinically significant pleural effusion.
* Patients with a history of epilepsy, cerebrovascular ischemia / hemorrhage, cerebellar disease or other active central nervous system diseases.
* Lymphoma affects the atrium or ventricle.
* Clinical emergencies (such as intestinal obstruction or vascular compression) that requires urgent treatment due to obstruction or compression of lymphoma tumors during screening.
* History of deep vein thrombosis or pulmonary embolism within 6 months of screening.
* Known history of hypersensitivity to ingredients used in the drug.
* Has had treat with live vaccine within 6 weeks prior to screening.
* Patients with evidence of currently uncontrollable serious active infections (e.g., sepsis, bacteremia, fungemia, viremia, etc.).
* Life expectancy < 12 weeks.
* Patient in other interventional clinical studies within 3 months before the CNCT19 infusion, who have received active drug therapy, or who intend to participate in another clinical trial or receive anti-tumor therapy outside the protocol during the entire study.
* Patients with other conditions making the patients unsuitable for receiving cell therapy as judged by the investigator.
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Study Objectives
The aim of the project is to assess the associations between biomarkers of acrylamide and glycidol exposure and disease outcomes in a case-cohort study based on two prospective cohorts with biobanks. The investigators also aim to assess the exposure-affected OMICS signatures and molecular pathways underlying disease development (specifically cardiovascular diseases such as myocardial infarction and stroke and cancer such as breast-, endometrial and colorectal cancer) for these exposures along with persistent organic pollutants (POPs) and per- and polyflouroalkyl substances (PFAS) using a prospective cohort study utilizing and integrating various 'OMICs' technologies.
Intervention / Treatment
OTHER: Biomarkers of acrylamide, glycidol, POPs, PFAS
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Inclusion Criteria:
* 60YO: Men and women of 60 years old residing in Stockholm
* SMC-C: Women residing in Uppsala
Exclusion Criteria:
* Subjects will be excluded if they had the outcome under investigation at baseline
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Study Objectives
The purpose of this study is to look for markers of how Ra-223 improves the lives of men with prostate cancer. This study makes use of Ra-223 in the standard FDA-approved way, but adds non-standard testing in an attempt to gain insight about how the drug works and how best to track patients who are receiving the drug.
Intervention / Treatment
PROCEDURE: Blood Tests, PROCEDURE: CT scan, PROCEDURE: FACBC PET/MRI in a subset of participants, DRUG: Radium-223 dichloride, PROCEDURE: bone scan
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Inclusion Criteria:
* Male age ≥ 18 years.
* Histologically or cytologically confirmed adenocarcinoma of the prostate. Life expectancy of at least 6 months.
* ECOG performance status of zero, one, or two.
* Bone-predominant metastatic CRPC: at least two skeletal metastases on bone scan with no lung, liver, and/or brain metastasis (lymph node metastasis is allowed).
* Symptomatic as defined by either of the following:
* (a) Regular use of analgesic medication for cancer-related bone pain (≥ level 1; WHO ladder for cancer pain), or
* (b) Treatment with EBRT for bone pain (though EBRT must be completed ≥12 weeks prior to enrollment in this trial).
* Judged by investigator to have progressive disease sufficient to clinically justify standard-of-care radium-223 treatment.
* Subjects must be able to understand and be willing to sign the written informed consent form.
* All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v*0 Grade 1 or less at the time of signing the Informed Consent Form (ICF).
* No intention to use cytotoxic chemotherapy within the next 6 months. Subjects must agree to use adequate contraception beginning at the signing of the ICF until at least 6 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator.
* Acceptable hematology and serum biochemistry screening values:
* White Blood Cell Count (WBC) ≥ 3,000/mm3
* Absolute Neutrophil Count (ANC) ≥ 1,500/mm3
* Platelet (PLT) count ≥ 100,000/mm3
* Hemoglobin (HGB) ≥10 g/dl (Please note: it is acceptable from the standpoint of study eligibility to undergo transfusion in order to achieve hemoglobin ≥ 10 g/dl)
* Total bilirubin level ≤ *5 x institutional upper limit of normal (ULN)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ *5 x ULN
* Creatinine ≤ *5 x ULN
* Albumin > 25 g/L
* Willing and able to comply with the protocol, including follow-up visits and examinations.
Exclusion Criteria:
* Treatment with cytotoxic chemotherapy within previous 28 days, or failure to recover from AEs due to cytotoxic chemotherapy administered more than 28 days previous (however, ongoing neuropathy is permitted).
* Received any investigational compound within 28 days prior to the first dose of study drug or planned during the treatment period or follow-up.
* Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or Radium Ra 223 dichloride) for the treatment of bony metastases.
* Received previous radiotherapy to approximately >25% of bone marrow.
* Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer).
* Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) or other imaging modality.
* Presence of brain metastases.
* Lymphadenopathy exceeding 6 cm in short-axis diameter.
* Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis.
* Imminent spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Treatment should be completed for spinal cord compression.
* Any other serious illness or medical condition, such as but not limited to:
* Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version *03 Grade 2
* Cardiac failure New York Heart Association (NYHA) III or IV
* Crohn's disease or ulcerative colitis
* Known bone marrow dysplasia
* Fecal incontinence.
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
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Study Objectives
This was a propensity-score matched observational analysis, comparing the oncological outcome of surgical resection vs watch and wait apporach for rectal cancer patients with a cCR.
Intervention / Treatment
PROCEDURE: standard TME surgery
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Inclusion Criteria:
* Pathologically confirmed stage II/III rectal adenocarcinoma patients who received neoadjuvant chemoradiotherapy followed by a clinical complete response
Exclusion Criteria:
* history of a second primary malignancy.
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Study Objectives
Purpose: The purpose of this pilot study is to evaluate whether MRI of the breasts with diffusion-weighted MR imaging can identify features more specific for breast cancer in women at high-risk of developing breast cancer.
Participants: One hundred asymptomatic women at high-risk for breast cancer recommended for a clinical breast MRI identified through the UNC Breast Clinic will be consecutively recruited for this study.
Procedures (methods): Each patient will undergo a clinical breast MRI and the addition of a single 90 second diffusion weighted sequence. A reader study will be conducted at UNC after the completion of patient accrual. The images will be analysed for lesions, enhancement patterns, diffusion weighted imaging data and correlated with any pathology or 1 year follow-up MRI exam. The study information will be entered into a secure database and analyzed.
Intervention / Treatment
PROCEDURE: Diffusion-weighted MR imaging
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Inclusion Criteria
* Women at high-risk of breast cancer with an order for a clinical screening breast MRI.
* Asymptomatic women.
* Able to provide informed consent.
* At least 21 years of age.
Exclusion Criteria
* Women with symptom such as palpable mass or nipple discharge.
* Women with MRI/MRA contraindications such as a cardiac pacemaker, and aneurysm clip, cochlear implants, and metal in the eyes.
* Women who have had a moderate or severe contrast reaction to intravenous gadolinium-DTPA.
* Women who are not able to give consent.
* Women diagnosed with breast cancer within the last 6 months.
* Women who are pregnant.
* Male patients.
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Study Objectives
The purpose of this study is to test whether Degarelix is associated with less endothelial dysfunction (an intermediate in the development of cardiac disease) and cardiovascular biomarkers compared to LHRH agonists.
Intervention / Treatment
DRUG: Degarelix (LHRH antagonist), DRUG: LHRH agonist, DEVICE: EndoPAT2000
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Inclusion Criteria:
* Male patients with locally advanced or metastatic prostate cancer or high-risk prostate cancer.
* Scheduled to start ADT for a period of at least one year.
* Subject has a history of one or more of the following:
* Myocardial infarction
* Ischaemic or Haemorrhagic cerebrovascular conditions
* Arterial embolic and thrombotic events,
* Ischaemic heart disease
* Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)
* Peripheral vascular disease (e.g. significant stenosis (ABPI<*9), claudication, prior vascular surgery/intervention)
* Life expectancy of over 12 months.
* WHO performance status of 0-2
* Subject is able and has agreed to sign a consent form.
Exclusion Criteria:
* Prior use of ADT. However, prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat will be allowed.
* Prior use of dutasteride/finasteride in past 6 months
* Known allergic reaction to Degarelix.
* Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.
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Study Objectives
The purpose of this research is to determine whether the drug, Bevacizumab (a monoclonal anti VEGF-A antibody), which is approved to treat patients with metastatic colon cancer induces hyperprolactinemia (increased prolactin secretion) in humans with intact pituitary function. Past studies have shown Bevacizumab to shrink tumor size and also increase prolactin levels. The mechanism of the hyperprolactinemia might be inhibition of pituitary portal vein transport, suggesting that Bevacizumab induces prolactin secretion from normal lactotrophs in the pituitary gland.
Patients who have been treated with Bevacizumab for at least one month will be recruited to participate.
The subjects who are being treated with Bevacizumab by Dr. Stephen Wolin (a sub-investigator) will be screened by him for study eligibility. Dr. Wolin will approach eligible patients with all the information and background of the study and see if they have an interest in being consented.
If consented, there will be 2 blood draws for the research that is not part of their standard care in which 10 ml of blood is collected and prolactin, growth hormone, IGF-I, TSH, thyroxine, ACTH, and cortisol will be measured. One 5ml blood draw will occur before the administration of Bevacizumab and the second 5 ml blood draw will occur after the administration of the Bevacizumab. The investigators will then review the laboratory results. The blood tests are of the hormones of the pituitary gland to test pituitary function and see if there are any abnormalities with the secretions of the gland. Pituitary function abnormalities and hyperprolactinemia are diagnosed by looking at hormone levels in the blood and comparing them to the normal reference ranges.
This study will only involve 10 subjects and will be conducted entirely at Cedars-Sinai Medical Center.
Intervention / Treatment
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Inclusion Criteria:
* Patients with colorectal cancer, lung cancer, breast cancer, and glioblastoma patients that have been treated with Bevacizumab for at least 1 month
* Adults (18 years of age or older)
Exclusion Criteria:
* Patients who are taking medications known to affect serum prolactin levels
* Patients who are pregnant
* Patients who have pituitary disease
* Minors (Under the age of 18)
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Study Objectives
Study objective is to determine the effect of High intensity interval training on psychological wellbeing, Anthropometrics and Quality of life in females with Polycystic Ovarian Syndrome
Intervention / Treatment
OTHER: Low Intensity steady state training, OTHER: High intensity interval training
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Inclusion Criteria:
* females 18 to 45 years of age
* Diagnosed with PCOS based on Rotterdam criteria
* Ferriman and Gallway score of >8 for hirsutism
Exclusion Criteria:
* Use of hormonal contraceptives or IUDs for contraception
* Taking metformin <3 months prior to the inclusion
* Breast feeding mothers
* Type I or II DM
* Hypo/hyperthyroidism
* Regular high-intensity endurance or strength training (defined as ≥ 2 sessions of vigorous exercise per week), Physical ailments/injuries that limited exercise performance.
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Study Objectives
The objective of this study was to evaluate the various parameters involved in the occurrence of nausea / vomiting during the first cycle of chemotherapy for solid tumors or hematologic among a group of chemotherapy-naive patients, despite anti standardized-emetics protocols.
Intervention / Treatment
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Inclusion Criteria:
* Aged over 18 years
* With solid tumors or hematologic in first line chemotherapy, administered intravenously,
* Able to understand the meaning of the questions
* Having given their written consent to participate in the survey.
Exclusion Criteria:
This does not concern patients who:
* Do not give their consent for participation
* Do not speak French
* Suffer from cognitive deficits
* Are under therapy
* Must receive a combination of radio-chemotherapy
* Present an occlusive syndrome
* Metastases (s) brain (s) clinically symptomatic (s) or radiologically proven (s) or a (of) tumor (s) brain (s)
* Have been previously treated with chemotherapy
* Present a cons-indication to corticosteroids, with anti-serotonin or NK1 receptor inhibitors
* Pregnant or breastfeeding.
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Study Objectives
Radiotherapy and high dose chemotherapy with bone marrow transplantation or peripheral blood stem cell transplantation is frequently used as treatment for patients with cancers of the bone marrow or lymph nodes such as Hodgkin's disease, non-Hodgkin's lymphoma, leukemia or multiple myeloma. A common side effect of the radiotherapy and high dose chemotherapy is mucositis (inflammation of the inside of the mouth and throat resulting in pain and difficulty swallowing). Mucositis is often very severe such that patients receive intravenous nutrition and pain medication in the hospital.
In this study, an investigational recombinant human growth factor called Keratinocyte Growth Factor (rHuKGF) is being evaluated to determine its protective effect on the mucosal tissue and its ability to reduce the mouth and throat soreness.
Intervention / Treatment
DRUG: Recombinant Human Keratinocyte Growth Factor
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Inclusion Criteria: \* Patients with: non-Hodgkin's lymphoma, Hodgkin's disease, acute myelogenous leukemia, acute lymphoblastic leukemia, chronic myelogenous leukemia, chronic lymphocytic leukemia, or multiple myeloma \* Eligible for fractionated total body irradiation (fTBI) plus high-dose chemotherapy followed by autologous PBPC support. \* 18 years of age or older \* Karnofsky performance status greater than or equal to 70% \* Minimum of *5 Mio CD34+ cells/kg cryopreserved and to be transplanted \* Informed consent for participation in the study Exclusion Criteria: \* History of, or concurrent cancer other than NHL, Hodgkin's disease, AML, ALL, CML, CLL, multiple myeloma \* Prior bone marrow or peripheral blood stem cell transplantation \* Purged stem cell product \* Currently active infection or oral mucositis \* Congestive heart failure \* Serum creatinine > *5x ULN \* Direct bilirubin > *5x ULN \* Transaminases > 3x ULN \* Corrected DLCO < 50% of predicted \* Subject is currently enrolled in, or has not yet completed at least 30 days since ending other investigational device or drug trial(s) or is receiving other investigational agent(s). \* Subject is pregnant (eg, positive human chorionic gonadotropin \[HCG\] test) or is breastfeeding. \* Subject refuses to use adequate contraceptive precautions. \* Known hypersensitivity to any of the products to be administered during dosing, including E coli-derived products. \* Inability to give a truly informed consent.
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Study Objectives
This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.
Intervention / Treatment
PROCEDURE: Cryoablation
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Inclusion Criteria:
* 18 years of age or older
* Metastatic bone disease with metastatic disease previously confirmed by prior biopsy; or Metastatic bone disease previously confirmed on imaging \[e.g. computed tomography (CT) or magnetic resonance imaging (MRI)\] with known (biopsied) primary disease (primary bone cancer is excluded)
* Current analgesic therapies have failed OR the subject is experiencing intolerable side effects
* Unremitting pain that resulted in a return visit to the oncologist. The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of 0 (no pain) to 10 (pain as bad as subject can imagine) despite pharmaceutical pain management
* Pain must be from one or two painful metastatic sites in the bone that is amenable to cryoablation with CT or MRI (additional less painful metastatic sites may be present)
* Pain from the reported one or two metastatic sites must correlate with an identifiable tumor on CT, MRI, or ultrasound (US) imaging
* Tumors must be suitable for cryoablation
* Cryoablation should be performed within 14 days of baseline evaluations
* Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation procedure)
* Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
* ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3
* Life expectancy ≥ 2 months
* Platelet count >50,000/mm³ within 6 weeks screening
* INR (International Normalized Ratio) <*5 within 6 weeks screening
* No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
* If taking antiplatelet or anticoagulation medication, it must be able to be discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin, ibuprofen, low molecular weight heparin preparations)
* Clinically suitable for cryoablation therapy
Exclusion Criteria:
* Leukemia, lymphoma, and myeloma
* Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing > 50% loss of cortical bone
* Has undergone prior ablation treatment of the index tumor
* Prior radiation therapy of the index tumor <3 weeks prior to screening
* Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina compression/effacement
* Anticipated treatment of the index tumor that would require iceball formation within *0 cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder
* Surgery at the tumor site or surgery involving the cryoablation-treated tumor (index tumor)
* Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
* Patient currently with neutropenia (absolute neutrophil count <1000) within 6 weeks screening
* Uncontrolled coagulopathy or bleeding disorders
* Currently pregnant, nursing, or wishing to become pregnant during the study
* Active, uncontrolled infection
* Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to study entry
* Concurrent participation in other experimental studies that could affect the primary endpoint
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Study Objectives
The purpose of this study is to determine the usefulness of Cyberknife precision radiation in eliminating or preventing the further growth of spinal tumors and lesions.
Intervention / Treatment
PROCEDURE: Stereotactic radiosurgery
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Inclusion Criteria:- Intra-axial, extra-axial, or vertebral spinal lesion
* Age > 5
* Histologic confirmation of malignant primary lesion or radiographic diagnosis of benign or vascular spinal lesion
* No rapidly deteriorating symptoms of spinal cord compression
* No instability of the spine
* Life expectancy > 6 months Exclusion Criteria:- Patients without tumors of the spine
* Patients younger than 5 years old
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Study Objectives
Primary Objective:
* To determine the maximum tolerated dose of the combination of cisplatin, imatinib mesylate, and pemetrexed in metastatic malignant mesothelioma.
Secondary Objectives:
* To explore the biologic effects of cisplatin, imatinib mesylate, and pemetrexed on tumor tissue by:
* histologic analysis of biopsy tissue
* by non-invasive assessments of tumor vascularity performed before, during and after treatment
* electron microscopy analysis of endothelial cell architecture after patient treatment with imatinib mesylate
* To explore the effects of cisplatin, imatinib mesylate, and pemetrexed on surrogate markers in serum.
* To assess the rate of response to therapy.
* To determine the doses of the combination regimen of cisplatin, imatinib mesylate, and pemetrexed that enables de-phosphorylation of platelet derived growth factor receptor (PDGF-R) on malignant mesothelioma tumor cells.
* To determine the pharmacokinetic interaction between agents in this combination regimen.
Intervention / Treatment
DRUG: Cisplatin, DRUG: Imatinib Mesylate, DRUG: Pemetrexed, DRUG: Dexamethasone
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Inclusion Criteria:
* A written, voluntary informed consent form must be completed prior to beginning any study procedure.
* Patients >/= 18 years of age.
* Histologically documented diagnosis of malignant mesothelioma.
* Performance status 0-2 (ECOG)
* Patients must have adequate hepatic,renal,\& bone marrow function,defined as the following:* total bilirubin </=*5xULN;* serum glutamate oxaloacetate transaminase (SGOT) \& serum glutamate pyruvate transaminase (SGPT)</=*5xULN;*creatinine </= *5xULN;* ANC >/= *5x10\^9/L;* platelets>/=100 x 10\^9/L.Note:Renal function is only based on serum creatinine level </= *5xULN.The standard Cockcroft \& Gault formula or the measured glomerular filtration rate (GFR) using the appropriate radio labelled method (51-CrEDTA or Tc99m-DTPA) must be used to calculate cranial cruciate ligament (CrCl) for enrollment or dosing.The same method used @ baseline should be used throughout the study.CrCl should be >/= 45mg/dl.
* Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
* Patients who have not received prior chemotherapy for their metastatic or recurrent unresectable malignant mesothelioma; with the exception of patients who have recurrent mesothelioma after induction chemotherapy followed by definitive treatment (surgery +/- radiotherapy). Patients must have had 2 or fewer cycles/doses of induction chemotherapy and must have had tumor response to the induction therapy.
* Patients must have documented unresectable malignant mesothelioma (pleural or peritoneal).
* Patients with treated brain metastasis who have stable brain disease (i.e. no steroids at least 4 weeks prior to study enrollment).
Exclusion Criteria:
* Patient has received any other investigational agents within 28 days of first day of study drug dosing.
* Patient is </= 5 years free of another primary malignancy except: if the other primary malignancy is not currently clinically significant nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer, squamous skin cancer, or a cervical carcinoma in situ.
* Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure)
* Patients with myocardial infarction within 6 months of study.
* Female patients who are pregnant or breast-feeding.
* Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
* Patient has a known untreated or unstable brain metastasis.
* Patient has known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis).
* Patient has a known diagnosis of human immunodeficiency virus (HIV) infection. HIV patients are at much greater risk of infection when receiving highly myelosuppressive agents (cisplatin, pemetrexed, and imatinib) and for safety reasons are not eligible for this trial.
* Patient who received prior chemotherapy for their malignant mesothelioma with the exception listed in inclusion criteria #*
* Patient previously received radiotherapy to >/= 25 % of the bone marrow.
* Patient had a major surgery within 2 weeks prior to study entry.
* Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
* Patients must agree not to use herbal remedies or other over-the-counter biologics (i.e. shark cartilage).
* Prior exposure to imatinib mesylate.
* Patients taking therapeutic levels of warfarin. However, patients receiving 1 mg daily for catheter related anticoagulation are eligible for the study.
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Study Objectives
The primary endpoint of this study is to compare the humoral response (titre and neutralizing capacity of induced antibodies) against SARS-CoV-2 following vaccination with BNT162b2 (Pfizer BioNTech) in immunocompromised persons, in comparison to healthy subject. Secondary objectives are to evaluate the humoral response in the nasal mucosa, and the capacity of antibodies to neutralize emerging variants of concerns and to prevent COVID-19.
Intervention / Treatment
BIOLOGICAL: Biological samples
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Inclusion Criteria:
* Adult volunteers to be vaccinated with the ComirnatyTM vaccine and to participate in the study, belonging to one of the following groups:
* Group of immunocompromised (15 participants per immunosuppression subgroup):
* Kidney transplant
* Extracorporeal dialysis
* Solid cancer under chemotherapy and / or radiotherapy
* Myeloma under chemotherapy
* Hematologic malignancies under chemotherapy
* Diseases treated with anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
* Multiple sclerosis under anti CD20 (or patients not treated at the time of the vaccine but who will be immediately after)
* Common variable immune deficiency or other causes of severe hypogammaglobulinemia requiring chronic treatment with polyvalent immunoglobulin
* Malignant tumor under anti-PD1 or anti-PDL1
* People living with HIV
* Complicated type 2 diabetes (with micro and / or macroangiopathy)
* Group of non-immunocompromised subjects (controls, n = 75)
* 60 people vaccinated with the ComirnatyTM
* 15 people vaccinated with Astra Zeneca's VaxzevriaTM for the first dose
Exclusion Criteria:
* Minors
* Pregnant or breastfeeding women
* Persons under tutorship or curatorship
* Protected adults
* Person under legal protection
* Person not affiliated to a social security scheme
* People with a contraindication to receiving the ComirnatyTM vaccine
* People who have already been vaccinated against SARS-CoV-2
Note: a history of COVID-19 (> at 3 months) is not a contraindication to vaccination and is therefore not a criterion for non-inclusion in the study.
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Study Objectives
Despite an increase in longevity, surviving ovarian cancer often brings an array of unpleasant side effects and compromises in QOL. Our proposed trial will be the first study to test whether exercise compared with attention control has a beneficial impact on quality of life, fitness and surrogate markers of ovarian cancer. Our trial could suggest a unique and important role for exercise in ovarian cancer care given that physical and functional aspects of QOL are often the most compromised in ovarian cancer patients.
Intervention / Treatment
BEHAVIORAL: Exercise
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Inclusion Criteria:
* stage I-IV ovarian cancer
* less than 76 yrs of age
Exclusion Criteria:
* exercising
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Study Objectives
The purpose of this study is to evaluate the safety, tolerance and Dose-Limiting Toxicity (DLT) of Recombinant humanized anti-PD-1 monoclonal antibody (JS001) in patients with advanced solid tumors.
Intervention / Treatment
BIOLOGICAL: humanized anti-PD-1 monoclonal antibody toripalimab
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Inclusion Criteria:
* Histological or cytological diagnosis of advanced or recurrent adenocarcinoma of solid tumor, including adenocarcinoma of the stomach or gastro-esophageal junction, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, cholangiocarcinoma, Pancreatic ductal cell carcinoma, etc.
* at least one prior chemotherapy regimen
* age between 18 and 75 years, both gender
* has at least one measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST V*1)
* life expectancy ≥ 3 months
* ECOG performance status of 0 or 1
* Has had last dose of chemotherapy more than 4 weeks prior to the first dose of study therapy JS001, and has recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version *0 Grade 1 or better from the AEs due to the chemotherapy.
* Has had last administration of radioactive therapy more than 4 weeks prior to the first dose of study therapy JS*
* Has had last administration of immunosuppressive systemic steroid therapy (more than 10 mg/d prednisone or equal dose) more than 2 weeks prior to the first dose of study therapy JS*
* Has undergone major surgery that needs general anesthesia more than 4 weeks prior to the first dose of study therapy JS* Has undergone surgery that needs local anesthesia or epidural anesthesia more than 72 hours prior to the first dose of study therapy JS001 and has already recovered from the surgery. Has undergone biopsy more than 1 hour prior to the first dose of study therapy JS*
* The lab examination results of the screening must fulfill all of the following:
* absolute neutrophil count more than or equal to *5×109/ L
* platelet count more than or equal to 90×109/ L
* hemoglobin more than or equal to 90 g/L
* creatinine less than or equal to*6µmol/L or creatinine clearance >40 mL/min
* aspartate transferase(AST) and alanine transferase(ALT) less than or equal to *0 ×ULN
* total bilirubin less than or equal to *5×ULN( except for the patients with Gilbert syndrome, whose total bilirubin ,must less than or equal to *3µmol/L)
* Patient has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to participation in any study related activities.
* Able to adhere to the study visit schedule and other protocol requirements.
Exclusion Criteria:
* Has had antineoplastic herbal therapy within 2 weeks prior to the first dose of study therapy JS*
* Is currently participating and receiving study therapy or has participated in a study of an investigational agent and receive study therapy or used an investigational device within 4 weeks of the first dose of study drug.
* Has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication.
* Has a known history of a hematologic malignancy, primary brain tumor or sarcoma, or of another primary solid tumor, unless the participant has undergone potentially curative therapy with no evidence of that disease for 5 years.
* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Has interstitial lung disease OR has had a history of pneumonitis that has required oral or IV steroids.
* Has active or suspected autoimmune disease except leukoderma,type I Diabetes, Residual hypothyroidism that induced by autoimmune thyroiditis and only requires the use of hormone replacement therapy, Or disease that rarely relapse without external stimulating factors.
* Had prior treatment targeting PD-1: anti-PD-1,anti-PD-L1, anti-PD-L2, cytotoxic T-lymphocyte-associated protein (CTLA), or other antibodies that targeting T cell costimulatory pathway or checkpoint.
* Has an active infection requiring systematic therapy.
* Is positive for Human Immunodeficiency Virus (HIV).
* Has active Tuberculosis.
* Has known active Hepatitis B or C.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
* Has received or will receive a live vaccine within 30 days prior to the first administration of study drug.
* Is pregnant or breastfeeding.
* Cannot tolerate vein puncture and / or venous access.
* Any other conclusive medical reasons, mental illness, and / or social reasons that determined by the investigators.
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Study Objectives
This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been treated.
Intervention / Treatment
DRUG: Letrozole, DRUG: Palbociclib, DRUG: Goserelin, DIAGNOSTIC_TEST: Oncotype DX Breast Recurrence Score
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Inclusion Criteria:
* Patients must be premenopausal. Patients with a hysterectomy: menopausal status must be confirmed by estradiol and FSH.
* Operable hormonal receptor (HR) positive (ER/PR greater than or equal to 10%), HER2- negative, invasive early breast cancer, suitable for neoadjuvant AI treatment and ovarian suppression; HR- positive and HER2-negative as determined by American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP ) guidelines.
* Diagnostic breast tissue must have an Oncotype DX Breast Recurrence Score® of less than 26 as determined by Genomic Health, Inc.
* No known severe hypersensitivity reactions to compounds similar to palbociclib or palbociclib excipients or to endocrine treatments.
* A breast tumor with an ultrasound size of at least *0 cm.
* Patients must have the ability to swallow oral medication.
* ECOG performance status of 0 or *
* At the time of randomization, blood counts performed within 2 weeks prior to randomization must meet the following criteria:
* ANC must be greater than or equal to 1500/mm3
* Platelet count must be greater than or equal to 100,000/mm3
* Hemoglobin must be greater than or equal to 10g/dL.
* INR must be within normal limits of the local laboratory ranges. For laboratories that do not report an ULN for the INR assay, use less than or equal to *2 as the value for the ULN.
* The following criteria for evidence of adequate hepatic function performed within 2 weeks prior to study entry must be met:
* Total bilirubin must be less than or equal to ULN for the lab unless the patient has a bilirubin elevation greater than ULN to *5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and
* Alkaline phosphatase must be must be less than or equal to *5 x ULN for the lab; and
* AST and ALT must be less than or equal to *5 x ULN for the lab.
* Serum creatinine performed within 2 weeks prior to study entry must be less than or equal to *25 x ULN or estimated creatinine clearance greater than or equal to 60 mL/min (as calculated using the method standard for the institutions).
Exclusion Criteria:
* Active hepatitis B or hepatitis C with abnormal liver function tests.
* HIV positive patients receiving antivirals.
* Inflammatory/inoperable breast cancer.
* HER2-positive as determined using ASCO-CAP Guidelines.
* Oncotype Dx Breast Recurrence Score® result on diagnostic breast tissue greater than or equal to *
* Prior endocrine therapy for breast cancer.
* Any invasive malignancy within previous 5 years (other than basal cell carcinoma or cervical carcinoma in situ).
* Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow up such as:
* Active infection or chronic infection requiring chronic suppressive antibiotics;
* Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease or condition significantly affecting gastrointestinal function;
* Chronic daily treatment with corticosteroids with a dose of greater than or equal to 10 mg/day methylprednisolone equivalent (excluding inhaled steroids);
* Seizure disorders requiring medication.
* Diagnosis by fine needle aspiration (FNA) alone or excisional biopsy or lumpectomy performed prior to study entry.
* Surgical axillary staging procedure prior to study procedure (with exception of FNA or core biopsy).
* Definitive clinical or radiologic evidence of metastatic disease.
* History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with radiotherapy or contralateral invasive breast cancer at any time.
* Any treatment, including radiotherapy, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
* Use of any medication or substances that are strong inhibitors or inducers of CYP3A isoenzymes. Class III or Class IV myocardial disease as described by the New York Heart Association; a recent history (within 6 months) of myocardial infarction, or symptomatic arrhythmia at the time of randomization.
* Class III: Patients with cardiac disease resulting in marked limitation of physical activity. Such patients are comfortable at rest. Less than ordinary physical activity that causes fatigue, palpitation, dyspnea, or anginal pain.
* Class IV: Patients with cardiac disease resulting in inability to perform any physical activity without discomfort. Symptoms of cardiac insufficiency or anginal syndrome may be present even at rest.
* The investigator should assess the patient to determine if she has any psychiatric or addictive disorder or other condition that, in the opinion of the investigator, would preclude her from meeting the study requirements.
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Study Objectives
Participants in this study have a hematologic malignancy (a disorder in the bone marrow that affects the body's ability to create blood) that might benefit from receiving an allogeneic stem cell transplant (meaning the cells come from a donor) from a family member or nearly identical matched donor. The donor may either be a matched sibling, a mismatched family member, or an unrelated person.
Usually these patients are given high doses of chemotherapy before receiving a stem cell transplant to keep their immune system from rejecting the donor stem cells and to kill any diseased cells that remain in the body. However, this group of patients have a high risk of developing possibly life-threatening treatment-related side effects such as infections, damage to vital organs such as lungs, liver, kidney and heart, as well as graft versus host disease (GVHD).
Instead of the high dose chemotherapy and radiotherapy usually given before a transplant, this research study uses a new pre-transplant combination of three drugs, Fludarabine, Anti-CD45 and CAMPATH-1H with low dose radiotherapy. Fludarabine is a chemotherapy drug while Anti-CD45 and CAMPATH-1H are antibodies against certain types of blood cells, including those which are causing this disease. CAMPATH-1H is particularly important because it stays active in the body for a long time after it is given, which means it may work longer to prevent GVHD symptoms. Anti-CD45 may help in eradicating residual malignant cells. All these agents also help in preventing rejection of donor stem cells. This study is designed to give a less intense chemotherapy and radiotherapy, so that the life-threatening toxicities of conventional high dose chemotherapy and radiotherapy regimen can be reduced, while maintaining the ability to cure cancer.
Intervention / Treatment
DRUG: ANTI-CD45, DRUG: CAMPATH-1H, DRUG: FK506, DRUG: Fludarabine, RADIATION: Total Body Irradiation, PROCEDURE: Stem cell infusion
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Inclusion Criteria:
* Patients with one of the following high risk diseases needing allogeneic hemopoietic stem cell transplantation:
Acute myeloid leukemia either a) Primary refractory, or b) Beyond first complete remission(CR1), or c) In CR1 with high risk of relapse
Acute lymphoblastic leukemia either a) Primary refractory, or b) Beyond first complete remission(CR1), or c) In CR1 with high risk of relapse
Chronic myeloid leukemia, either a) Accelerated phase, or b) Blast crisis, or c) Chronic phase and not achieving major cytogenetic response despite standard therapy
Chronic lymphocytic leukemia, either a) Primary refractory, or b) Beyond first complete remission(CR1),
Non Hodgkin's lymphoma, either a) Primary refractory, or b) Beyond first complete remission(CR1)
Hodgkin's disease, either a) Primary refractory, or b) Beyond first complete remission(CR1),
Myelodysplastic syndrome with IPSS score > * (Appendix A)
Myeloproliferative disorders (with the exclusion of chronic myeloid leukemia) a) Primary Myelofibrosis with Lile score of 1 or 2 (Appendix B) b) Polycythemia Vera or Essential Thrombocythemia transformed to AML or Myelofibrosis and PV "spent phase"
Multiple Myeloma with stage II or III disease
Severe aplastic anemia
* Conditions that increase Treatment Related Mortality (need one or more to be eligible):
Greater or equal to 35 years of age;
Ejection Fraction of less than 50%;
DLCO less than 50% or FEV1/FVC < 80% of predicted value;
Diabetes Mellitus;
Renal insufficiency (serum creatinine abnormal);
Hepatic dysfunction-transaminases, or alkaline phosphatase, or bilirubin twice the upper limit of normal;
Prior recent history of systemic fungal infection;
Multiple prior treatment regimens (equal to or more than 3);
Significant Grade III or IV neurologic, cardiac, pulmonary, renal or hepatic toxicity from previous treatment;
Prior Autologous or Allogeneic Stem Cell transplantation;
* Available Healthy Donor without any contraindications for donation. 5/6 or 6/6 related or unrelated donor (molecular typing for DRB1);
* Patient and/or responsible person able to understand and sign consent
Exclusion Criteria:
Pregnant and lactating women, or women unwilling to use contraception.
HIV positive patient
Unstable angina and uncompensated congestive heart failure (Zubrod of 3 or greater)
Severe chronic pulmonary disease requiring oxygen (Zubrod of 3 or greater)
Child's class C cirrhosis
Unstable cerebral vascular disease or recent hemorrhagic stroke (less than 6 months)
Patients with known allergy to rat serum products
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Study Objectives
Esophageal cancer is the eighth most common cancer around the world, with more than 450000 new cases per year. Esophagectomy with radical lymphadenectomy (2-field lymphadenectomy) is the mainstay of treatment in many countries for patients with esophageal cancer. To improve the survival, 3-field lymphadenectomy combined with cervical lymphadenectomy was started in 1980s. More potential positive lymph nodes were found during more extended lymphadenectomy, offering more accurate TNM staging, affecting consequent treatment. However，3-field-lymphadenectomy was associated with increased surgical morbidity and mortality. Positron emission tomography (PET) is used for detecting distant metastases and lymphatic involvement. The aim of the study is to evaluate the role of PET in predicting cervical lymph metastases of patients with thoracic esophageal squamous cell carcinoma, and to determine if investigators can use PET to guide future cervical lymphadenectomy. (Eastern Cooperative Thoracic Oncology Projects 2003, ECTOP-2003)
Intervention / Treatment
DIAGNOSTIC_TEST: positron emission tomography
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Inclusion Criteria:
* Histologically proven esophageal cancer
* Resectable cT1-T3/N0-N1 thoracic，operable esophageal lesion. Staging investigations including esophagogastroscopy, chest and abdominal CT scan, and barium swallow
* Karnofsky performance status greater than or equal to 80%
* Acceptable pulmonary and cardiac function.
* Acceptable hepatic, renal and bone marrow function
Exclusion Criteria:
* Low performance status(Karnofsky score <80%)
* Past history of malignancy
* Unresectable advanced disease(T4 or M1a,M1b)
* Patients with any other serious underlying medical condition that would impair the ability of the patient to receive or comply with protocol treatment
* Medically unfit for surgical resection
* Pulmonary reserve inadequate to undergo thoracotomy and extensive mediastinal lymphadenectomy.
* A significant history of unstable cardiovascular disease that in the opinion of the treating physician should preclude the patient from protocol treatment.
* Uncontrolled diabetes mellitus or uncontrolled infection, including HIV or interstitial pneumonia or interstitial fibrosis.
* Significant psychiatric illness that would interfere with patient compliance
* Severe hepatic cirrhosis or with serious renal disease unacceptable for surgery
* Salvage surgery after definitive chemoradiotherapy
* Patients have neoadjuvant chemoradiotherapy
* Above the age of 80 years
* Unreliable for follow up
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Study Objectives
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation of fold increase in circulating CD34+ cells from just before the first plerixafor injection to 10-11 hours post plerixafor (just before apheresis) and assessment of successful polymorphonuclear leukocyte (PMN) engraftment after transplantation. Data from this protocol will assist in the determination of the dosing schedule for future studies.
Intervention / Treatment
DRUG: G-CSF Plus Plerixafor
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Inclusion Criteria:
* Diagnosis of non-Hodgkin's lymphoma (NHL) or multiple myoloma (MM) eligible for autologous transplantation
* No more than 3 prior regimens of chemotherapy
* More than 4 weeks since last cycle of chemotherapy. Patient recovered from all acute toxic effects of prior chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* White blood cell (WBC) count >*0\*10\^9/L
* Absolute polymorphonuclear cells (PMN) count >*5\*10\^9/L
* Platelet (PLT) count >100\*10\^9/L
* Serum creatinine <=*2 mg/dL
* Serum glutamic oxaloacetic transaminase (SGOT), serum glutamic pyruvic transaminase (SGPT) and total bilirubin <2 x upper limit of normal (ULN)
* Left ventricle ejection fraction >45% by normal echocardiogram or multiple-gated acquisition (MUGA) scan
* Forced expiratory volume of the lung in the first second (FEV1) >60% of predicted or diffusing capacity of the lung for carbon monoxide (DLCO) >45% of predicted
* Negative for human immunodeficiency virus (HIV) type 1
* Women of child bearing potential agreed to use an approved form of contraception.
Exclusion Criteria:
* * Patients who have failed previous collections
* Brain metastases or carcinomatous meningitis
* History of ventricular arrhythmias
* A co-morbid condition which, in the view of the investigator, renders the patient at high risk for treatment complications
* A residual acute medical condition resulting from prior chemotherapy
* Acute infection
* Fever (temp >38°C/*4°F)
* Patients whose actual body weight exceeds 150% of their ideal body weight
* History of paresthesias (at least Grade 2)
* Patients who previously received experimental therapy within 4 weeks of enrolling in this study or who are currently enrolled in another experimental study during the mobilization period
* Positive pregnancy test in female patients
* Lactating females
* Patients of child-bearing potential unwilling to implement adequate birth control.
* Patients who have deterioration of their clinical status or laboratory parameters between the time of enrolment and transplant (such that they no longer meet entry criteria) may be removed from study at the discretion of the treating physician, principal investigator, or sponsor.
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Study Objectives
This study will measure the effectiveness and any side effects of LY317615 in participants with diffuse large B-cell lymphoma (DLBCL: a sub-type of Non-Hodgkins Lymphoma).
Intervention / Treatment
DRUG: LY317615
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Inclusion Criteria:
* A diagnosis of recurrent or refractory DLBCL.
* Adequate organ functions.
* Able to swallow capsules.
Exclusion Criteria:
* More than 3 prior treatments for this disease.
* Serious heart problems.
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Study Objectives
This is a prospective, observational, non-interventional, multicenter, post-marketing surveillance study to mainly collect safety information from subjects with locally advanced and recurrent/metastatic Squamous Cell Carcinoma of Head and Neck (SCCHN) treated with cetuximab based on the locally approved label.
Intervention / Treatment
OTHER: No Intervention
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Inclusion Criteria:
* Histologically proven Stage 3-4 locally advanced SCCHN (oropharynx, hypopharynx, larynx) or recurrent and/or metastatic SCCHN
* Age greater than or equal to 18 years
* Signed informed consent
Exclusion Criteria:
* Subjects with known severe (Grade 3 or 4; National Cancer Institute Common Toxicity Criteria Version *03) hypersensitivity reactions to Cetuximab
* Subjects with contraindications for concomitantly used chemotherapeutic agents or radiation therapy, identified before initiation of cetuximab combination treatment
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Study Objectives
This is an open label long term follow up study, open to those subjects who were previously enrolled in"RAD001 Therapy of Angiomyolipomata in Patients with Tuberous Sclerosis Complex and Sporadic Lymphangioleiomyomatosis", CCHMC IRB #2008-0812 and who meet the criteria for this long-term follow-up study.
The hypothesis is that the drug will inhibit the growth of the angiomyolipomas and possibly even cause regression.
Intervention / Treatment
DRUG: everolimus (RAD001)
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Inclusion Criteria:
* Subjects must have met all eligibility criteria for the initial RAD001 protocol (CCHMC IRB 2008-0812)
* Subjects with documented angiomyolipoma volume decrease from baseline measures at the end of 12 months on study drug of thirty percent or more during the initial RAD001 protocol OR subjects with less than thirty percent decrease in angiomyolipomas at the end of 12 months on study drug but with documented improvement, or stabilization, of baseline clinical status per physical, pulmonary function and/or laboratory examination at the end of 12 months on study drug that was not maintained during a period of 12 or more months off study drug.
* If female and of child-bearing potential, documentation of negative pregnancy test prior to start of study drug
* Creatinine <3 mg/dl, within 30 days prior to start of drug
Exclusion Criteria:
* Inability to complete the initial RAD001 protocol (CCHMC IRB # 2008-0812) due to toxicities requiring discontinuation of treatment.
* Demonstrated an increase in the size of the angiomyolipoma from baseline at the end of 12 months on study drug on the initial RAD001 study.
* Significant hematologic or hepatic abnormality (i.e. ALT and AST >*5x ULN), serum albumin <3 g/dl, HCT <30%, platelets <75,000/cumm, adjusted absolute neutrophil count <1,000/cumm, total WBC <3,000/cumm).
* Continuous requirement for supplemental oxygen.
* Intercurrent infection at initiation of RAD*
* Embolization of angiomyolipoma within one month; any other recent surgery (within 2 months of initiation of RAD001).
* Pregnant or lactating women or women who plan on becoming pregnant during the course of this study due to unknown effects of RAD001 on the fetus.
* Inadequate contraception (participants who are fertile must maintain adequate contraception throughout the trial and for three months after stopping the drug). Acceptable contraceptive measures include non estrogen-containing birth control contraceptive regimen (progestin based contraceptives), prior hysterectomy, tubal ligation, complete abstinence, barrier methods which include a cervical diaphragm and spermicidal jelly, IUD, or vasectomy in partner.
* Use of an investigational drug, including rapamycin, within the last 30 days.
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Study Objectives
The primary objective of this study was to compare progression-free survival in patients with multiple myeloma who relapsed after 1 to 3 prior therapies treated with carfilzomib plus dexamethasone or bortezomib plus dexamethasone.
Intervention / Treatment
DRUG: Carfilzomib, DRUG: Bortezomib, DRUG: Dexamethasone
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Inclusion Criteria:
* Multiple myeloma with relapsing or progressing disease at study entry.
* Patients must have evaluable multiple myeloma with, at least one of the following (assessed within 21 days prior to randomization):
* Serum M-protein ≥ *5 g/dL, or
* Urine M-protein ≥ 200 mg/24 hour, or
* In patients without detectable serum or urine M-protein, serum free light chain (SFLC) > 100 mg/L (involved light chain) and an abnormal serum kappa/lamda ratio, or
* For immunoglobulin (Ig) A patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ≥ 750 mg/dL (*75 g/dL).
* Patients must have documented at least partial response (PR) to at least 1 line of prior therapy. PR documentation can be based on Investigator assessment.
* Received 1, but no more than 3 prior treatment regimens or lines of therapy for multiple myeloma. (Induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy).
* Prior therapy with Velcade is allowed as long as the patient had at least a PR to prior Velcade therapy, was not removed from Velcade therapy due to toxicity, and will have at least a 6 month Velcade treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month Velcade treatment-free interval).
* Prior therapy with carfilzomib is allowed as long as the patient had at least a PR to prior carfilzomib therapy, was not removed from carfilzomib therapy due to toxicity, and had at least a 6-month carfilzomib treatment-free interval from last dose received until first study treatment. (Patients may receive maintenance therapy with drugs that are not in the proteasome inhibitor class during this 6 month carfilzomib treatment-free interval). The exception to this is patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
* Males and females ≥ 18 years of age.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to *
* Adequate hepatic function within 21 days prior to randomization, with bilirubin < *5 times the upper limit of normal (ULN), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times the ULN.
* Left ventricular ejection fraction (LVEF) ≥ 40%.
* Absolute neutrophil count (ANC) ≥ 1000/mm³ within 21 days prior to randomization. Screening ANC should be independent of growth factor support for ≥ 1 week.
* Hemoglobin ≥ *0 g/dL within 21 days prior to randomization. Use of erythropoietic stimulating factors and red blood cell (RBC) transfusions per institutional guidelines is allowed, however most recent RBC transfusion may not have been done within 7 days prior to obtaining screening hemoglobin.
* Platelet count ≥ 50,000/mm³ (≥ 30,000/mm³ if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization. Patients should not have received platelet transfusions for at least 1 week prior to obtaining the screening platelet count.
* Calculated or measured creatinine clearance (CrCl) of ≥ 15 mL/min within 21 days prior to randomization. Calculation should be based on standard formula such as the Cockcroft and Gault:
\[(140 - Age) x Mass (kg) / (72 x Creatinine mg/dL)\]; multiply result by *85 if female.
* Written informed consent in accordance with federal, local, and institutional guidelines.
* Female patients of child-bearing potential (FCBP) must have a negative serum pregnancy test within 21 days prior to randomization and agree to use an effective method of contraception during and for 3 months following last dose of drug (more frequent pregnancy tests may be conducted if required per local regulations). FCBP is defined as a sexually mature woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
* Male patients must use an effective barrier method of contraception during study and for 3 months following the last dose if sexually active with a FCBP.
Exclusion Criteria:
* Multiple Myeloma of IgM subtype.
* Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 14 days prior to randomization.
* POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
* Plasma cell leukemia or circulating plasma cells ≥ 2 × 10\^9/L.
* Waldenstrom's Macroglobulinemia.
* Patients with known amyloidosis.
* Chemotherapy with approved or investigational anticancer therapeutics within 21 days prior to randomization.
* Patients randomized or previously randomized in any other Onyx-Sponsored Phase 3 trial.
* Focal radiation therapy within 7 days prior to randomization. Radiation therapy to an extended field involving a significant volume of bone marrow within 21 days prior to randomization (i.e., prior radiation must have been to less than 30% of the bone marrow).
* Immunotherapy within 21 days prior to randomization.
* Major surgery (excluding kyphoplasty) within 28 days prior to randomization.
* Active congestive heart failure (New York Heart Association \[NYHA\] Class III to IV), symptomatic ischemia, or conduction abnormalities uncontrolled by conventional intervention. Myocardial infarction within four months prior to randomization.
* Acute active infection requiring systemic antibiotics, antiviral (except antiviral therapy directed at hepatitis B) or antifungal agents within 14 days prior to randomization.
* Known human immunodeficiency (HIV) seropositive, hepatitis C infection, and/or hepatitis B (except for patients with hepatitis B surface antigen \[SAg\] or core antibody receiving and responding to antiviral therapy directed at hepatitis B: these patients are allowed).
* Patients with known cirrhosis.
* Second malignancy within the past 3 years except:
* adequately treated basal cell or squamous cell skin cancer
* carcinoma in situ of the cervix
* prostate cancer < Gleason score 6 with stable prostate-specific antigen (PSA) over 12 months
* breast carcinoma in situ with full surgical resection
* treated medullary or papillary thyroid cancer
* Patients with myelodysplastic syndrome.
* Significant neuropathy (Grades 3 to 4, or Grade 2 with pain) within 14 days prior to randomization.
* Female patients who are pregnant or lactating.
* Known history of allergy to Captisol(a cyclodextrin derivative used to solubilize carfilzomib).
* Patients with hypersensitivity to carfilzomib, Velcade, boron, or mannitol.
* Patients with contraindication to dexamethasone.
* Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs, or intolerance to hydration due to preexisting pulmonary or cardiac impairment.
* Ongoing graft-vs-host disease.
* Patients with pleural effusions requiring thoracentesis or ascites requiring paracentesis within 14 days prior to randomization.
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Study Objectives
Peripheral facial palsy is caused by damage to the facial nerve at any site of the peripheral branches after the facial nucleus.Stellate ganglion block is performed to treat peripheral facial palsy because it increases blood flow and promotes nerve regeneration.Facial Nerve Block worked with elimination of local inflammation of nerve and oppression. Facial nerve block is a treatment that inject drugs into the damaged nerve around to eliminate local inflammation and compression of the nerve.
Intervention / Treatment
PROCEDURE: Stellate Ganglion Block, PROCEDURE: Facial Nerve Block, DRUG: Mecobalamin Tablets
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Inclusion Criteria:
Diagnosed by clinical and neurological assessment as one-sided simple facial
* Age 18 to 75 years
* HBGS above Ⅳ
* the course of IFP not over 7 days.
Exclusion Criteria:
* Coagulation dysfunction
* plate plate plate shape, quantity or abnormal function
* mental system diseases
* Gillan-Bahrain syndrome
* cancer, mumps, shingles infection, jaw facial pus lymph nodeitis, encephalitis, -cerebral hemorrhage and other diseases
* local infection or systemic infectious disease at the puncture site
* can not accept to nerve block
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Study Objectives
The purpose of this study is to determine the highest tolerated dose, safety and activity of HCD122 in patients with Multiple Myeloma who are relapsed after receiving prior treatment.
Intervention / Treatment
DRUG: HCD122
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Inclusion Criteria:
* Clinical Diagnosis of MM requiring treatment
* Refractory or Relapsed Disease
* At least one prior treatment regimen
* Male or Female
* >18 years of age
Exclusion Criteria:
* Prior Allogeneic bone marrow transplant (prior autologous transplant allowed)
* Intracranial disease or epidural disease
* Clinically significant cardiac dysfunction or other significant organ dysfunction
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Study Objectives
The purpose of this study is to determine the DLT, MTD and recommended Phase II dose of ixabepilone in Japanese patients with solid tumors.
Intervention / Treatment
DRUG: Ixabepilone
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Inclusion Criteria:
* 20 years or older
* Histologically or cytologically confirmed diagnosis of adenocarcinoma Solid tumors
Exclusion Criteria:
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2
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Study Objectives
This study will look at the efficacy and safety of weekly administration of paclitaxel (Taxol®) in monotherapy compared to paclitaxel in combination with topotecan or carboplatin in patients with ovarian cancer in early relapse.
Intervention / Treatment
DRUG: Paclitaxel, DRUG: Topotecan, DRUG: Carboplatin
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Inclusion Criteria:
* Patients aged > 18
* Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneum
* Peritoneal and/or nodes and/or visceral metastases
* Disease in progression under treatment or within 6 months after a first or second platinum-based line
* A period of 3 weeks between last chemotherapy and inclusion
* Measurable disease (Response Evaluation Criteria in Solid Tumors \[RECIST\] criteria) or cancer antigen (CA) 125 assessable disease (Gynecologic Cancer Intergroup \[GCIG\] criteria)
* ECOG performance status < 2
* Life expectancy of at least 12 weeks
Exclusion Criteria:
* Previously received weekly administration of paclitaxel chemotherapy
* Involved in a trial within the last 30 days
* Previously received a bone marrow autogreffe or irradiation of the abdomen within 5 years, due to intensive chemotherapy
* Prior diagnosis of malignancy
* History of ischemic cardiopathy, congestive heart failure (New York Heart Association \[NYHA\] > 2), arrhythmia, hypertension, or significant valvulopathy
* Pre-existing motor or sensory neurologic pathology or symptoms National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) grade > 2
* Bone marrow, renal, or hepatic insufficiency
* Severe active infection or occlusive or sub-occlusive disease
* History of symptomatic brain metastases
* Fertile women not using adequate contraceptive methods
* Pregnant or breast feeding women
* Hypersensitivity to compounds chemically related to paclitaxel, topotecan, or carboplatin
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Study Objectives
To evaluate the safety and efficacy of CD19/CD22 Bispecific chimeric antigen receptor (CAR)-T for the treatment of measurable residual disaese (MRD)-positive B cell acute lymphoblastic leukemia. Patients will be given a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by a single infusion of CD19/CD22 CAR+ T cells.
Intervention / Treatment
BIOLOGICAL: anti-CD19/CD22 CAR-T cells, DRUG: Fludarabine, DRUG: Cyclophosphamide
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Inclusion Criteria:
* * CD19 positive/CD22 positive, or CD19-CD22 positive B-cell acute lymphoblastic leukemia;
* *18 to 70 Years Old, Male and female;
* * Expected survival > 12 weeks;
* * ECOG score 0-2;
* * Bone marrow examination clearly diagnosed as B-cell acute lymphoblastic leukemia and who met one of the following conditions:
* Recurrent patients who achieves MRD-positive CR or CRi after standard therapy;
* Those who achieves CR, but failed to achieve MRD-negative after at least 2 courses of consolidation therapy;
* For Ph-positive ALL patients, a history of at least one TKI application is required in addition to two standard chemotherapy treatments
* * The venous access required for collection can be established and mononuclear cell collection can be determined by the investigators;
* * Liver, kidney and cardiopulmonary functions meet the following requirements:
* Creatinine is in the normal range;
* Left ventricular ejection fraction >50%;
* Baseline oxygen saturation>92%;
* Total bilirubin ≤ 2×ULN;
* ALT and AST ≤ *5×ULN;
* * Able to understand and sign the Informed Consent Document.
Exclusion Criteria:
* * Malignant tumors other than acute lymphoblastic leukemia within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, and ductal carcinoma in situ after radical resection;
* * Subjects with positive HBsAg or HBcAb and peripheral blood HBV DNA titer detection ≥ 1 × 102 copy number / L; HCV antibody positive and peripheral blood HCV RNA positive; HIV antibody positive; CMV DNA positive; syphilis positive;
* * Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease;
* * Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment;
* * Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion;
* * Received CAR-T treatment or other gene therapies before enrollment;
* * Patients with symptoms of central nervous system;
* * Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell transfusion;
* * The investigators consider other conditions unsuitable for enrollment.
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Study Objectives
This project has been completed and consisted of a randomised trial of six tailored decision aids giving patients evidence-based information about faecal occult blood test screening for bowel cancer. 314 Australians aged between 50-74 years were recruited from five general practices and randomised to received either the tailored decision aid with age-gender and family history specific information and values clarification exercise or a standard government information sheet.
The decision aid significantly increased the proportion of people who were informed participants in the screening program.
Intervention / Treatment
BEHAVIORAL: Decision Aid
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Inclusion Criteria:
* People aged 50-74 years who were eligible for FOBT screening under current Australian guidelines and had not had screening for colorectal cancer in the preceding two years
Exclusion Criteria:
* Poor English, impaired cognition, significant comorbidity
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Study Objectives
The investigators will conduct a pragmatic clinical trial to test the effect of patient navigation on lung cancer screening (LCS) low-dose computed tomography (LDCT) completion among Boston Health Care for the Homeless Program (BHCHP) patients at increased risk for lung cancer. Patient navigation is a strategy for guiding individuals through complex health systems, and the investigators hypothesize that this may be a promising approach for helping homeless-experienced people overcome their unique barriers to obtaining LCS.
The investigators will aim to recruit 300 people to participate in this research study; 100 will be randomly assigned to arm 1 (usual care) and 200 will be randomly assigned to arm 2 (patient navigation). Randomization of participants will be stratified by smoking status, housing status, clinical site, and whether they have previously discussed LCS with their primary care provider (PCP) to ensure balance between study groups on these variables. People assigned to the usual care arm will be referred back to their PCP for further management. People assigned to the patient navigation arm will be given the chance to work with a LCS navigator. The navigator will assist participants and their PCPs with all aspects of the LCS process in addition to offering brief tobacco counseling for current smokers.
The primary aim of the trial is to determine-among homeless-experienced people who are eligible for LCS-the effect of patient navigation on 1) LCS LDCT completion at 6 months post-enrollment and 2) LCS LDCT completion at 6 months with diagnostic follow-up of abnormal results within 1 month of the recommended time frame. Study outcomes will be assessed by examining participant health records.
Following the intervention, qualitative interviews will be conducted with 40 participants and 10 BHCHP PCPs to better understand how the LCS process unfolds in the setting of homelessness, the ways in which the navigator facilitated this process, and opportunities for improving the navigation intervention for future use.
Intervention / Treatment
BEHAVIORAL: Patient Navigation
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Inclusion Criteria:
* Currently or formerly homeless
* Have a 30 pack-year smoking history and have smoked within the past 15 years
* Have a Boston Health Care for the Homeless (BHCHP) primary care provider (PCP)
* Proficient in English, assessed with items asking about native language and self-reported comfort communicating in English among non-native speakers
Exclusion Criteria:
* Prior chest computed tomography (CT) imaging in the past 12 months
* Personal history of lung cancer, or current presentation with symptoms concerning for lung cancer (e.g. hemoptysis or unexplained weight loss of >15 lbs. in the past year)
* PCP is the principal investigator
* Inability to provide informed consent, assessed with knowledge questions about the material presented during the informed consent process that individuals must correctly answer before providing informed consent to participate
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Study Objectives
Patients eligible for hormone ablation therapy who are prescribed Firmagon will be followed for a maximum of 3 years to estimate the progression free survival. Data on testosteron levels, QoL and LUTS will be collected if this information is available. Safety information (adverse events) will be collected.
Intervention / Treatment
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Inclusion Criteria:
* Patients with advanced hormone-dependent prostate carcinoma that are eligible for hormone therapy
Exclusion Criteria:
* Patients with a contraindication for prescription of Firmagon®
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Study Objectives
The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas. Additionally, the safety of RAD001 will be studied. RAD001 is a drug that may act directly on tumor cells by inhibiting tumor cell growth and proliferation.
Intervention / Treatment
DRUG: everolimus
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Inclusion Criteria:
* Patients must have histologic verification of one of the eligible diagnoses listed here: Astrocytoma variants; fibrillary, protoplasmic, mixed: Pilocytic astrocytoma; including pilomyxoid variants: Pleomorphic xanthoastrocytoma: infantile desmoplastic astrocytoma: ganglioglioma: oligodendroglial tumors: mixed glioma.
* Patients must have received at least one cancer-directed therapy and patients with allergies to carboplatin must have demonstrated progressive disease after cessation of therapy.
* Must have at least one measurable site of disease that has not been previously irradiated. If the patient has previous irradiation to the marker lesion(s), there must be evidence of progression since radiation treatment.
* Patients must be between 3 years of age and 21 years of age
* Karnofsky Performance Status of 50% or greater for patients less than 10 years of age or Lansky Score of 50% or greater for patients 10 and up.
* Participants must have recovered from the acute toxic effects of all prior chemotherapy or radiotherapy prior to entering the study. Refer to protocol for specific time restrictions with prior therapy completion.
* Adequate bone marrow function as defined in protocol
* Adequate renal function as defined in protocol
* Adequate liver function as defined in protocol
* Patients must have a fasting LDL cholesterol within the normal range per institutional guidelines
* Patients taking cholesterol lowering agent must be on a single medication and on a stable dose for at least 4 weeks
* Fasting serum cholesterol as outlined in protocol
* Patients must not be taking enzyme-inducing anticonvulsants
* Patients may not be currently receiving strong inhibitors of CYP3A4
Exclusion Criteria:
* Presence of NF1 by clinical examination or by genetic testing
* Patients who have had a major surgery or significant traumatic injury within 2 weeks of start of study drug, patients who have not recovered from teh side effects of any major surgery, or patients that may require major surgery during the course of the study
* Patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled are allowed
* Evidence of plexiform neurofibroma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment with chemotherapy or radiation therapy
* Uncontrolled brain or leptomeningeal metastases from plexiform neurofibromas, malignant peripheral nerve sheath tumors, or other cancers (other than astrocytoma variants; fibrillary, protoplasmic, mixed: Pilocytic astrocytoma; including pilomyxoid variants: Pleomorphic xanthoastrocytoma: infantile desmoplastic astrocytoma: ganglioglioma: oligodendroglial tumors: mixed glioma), including patients who continue to require glucocorticoids for control of symptoms related to brain or leptomeningeal metastases.
* Other malignancies within the past three years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study (see protocol for examples)
* Known history of HIV seropositivity
* Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001
* Active, bleeding diathesis or oral anti-vitamin K medication (except low dose coumarin)
* Female patients who are pregnant or breast feeding
* Prior treatment with an mTOR inhibitor
* Known hypersensitivity to RAD001 or other rapamycins or to is excipients
* Dental braces or prosthesis that interferes with tumor imaging
* Patients with a positive history of Hepatitis B or Hepatitis C
* Patients should not receive immunization with attenuated live vaccines within one week of study entry or during study period.
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Study Objectives
This phase II trial studies how well temsirolimus and bevacizumab work in treating patients with advanced endometrial, ovarian, liver, carcinoid, or islet cell cancer. Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of cancer by blocking blood flow to the tumor. Giving temsirolimus together with bevacizumab may kill more tumor cells.
Intervention / Treatment
BIOLOGICAL: Bevacizumab, DRUG: Temsirolimus
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Inclusion Criteria:
* Histologically or cytologically confirmed endometrial (endometrioid, uterine, papillary serous carcinoma, and carcinosarcoma), ovarian (primary peritoneal/fallopian tube, serous, endometrioid, mixed, and poorly differentiated epithelial ovarian cancers \[for purposes of eligibility, carcinosarcoma is considered a poorly differentiated carcinoma\]), hepatocellular carcinoma, carcinoid or islet cell (neuroendocrine: well- or moderately-differentiated neuroendocrine) cancer which are locally advanced, recurrent, or metastatic
* Patients must have measurable disease; patients having only lesions measuring >= 1 cm to < 2 cm must use spiral computed tomography (CT) imaging for both pre- and post-treatment tumor assessments; patients who have had prior palliative radiotherapy to metastatic lesion(s) must have at least one measurable lesion(s) that have not been previously irradiated
* Radiation therapy (adjuvant or palliative) must be completed >= 4 weeks prior to registration, if applicable
* Absolute neutrophil count (ANC) >= 1500/mm\^3
* Platelets >= 75,000/mm\^3
* Hemoglobin >= *0 g/dL
* Total bilirubin =< *5 x upper limit of normal (ULN); Note: direct bilirubin and international normalized ratio (INR) for hepatocellular carcinoma (HCC) patients allowed as per Child-Turcotte-Pugh scoring
* Alkaline phosphatase =< *5 x ULN (=< 5 x ULN if liver metastasis is present or patient is in HCC cohort)
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) =< *5 x ULN (=< 5 x ULN if liver metastasis is present or patient is in HCC cohort)
* Creatinine =<*5 x ULN
* Urinalysis < 2+ protein; urine protein should be screened by dipstick or urine analysis; for proteinuria >= 2+, 24-hour urine protein should be obtained and the level should be < 2 g for patient enrollment
* Fasting serum cholesterol =< 350 mg/dL (=< *0 mmol/L)
* Triglycerides =< *5 x ULN (mg/dL or mmol/L); patients with triglyceride levels > *5 x ULN can be started on lipid lowering agents and reevaluated within 1 week; if levels go to =< *5 x ULN, they can be considered for the trial and continue the lipid lowering agents; NOTE: cholesterol and triglyceride measurement and management are not required for single-agent bevacizumab cohort with islet cell carcinoma
* International normalized ratio (INR) =< *5 (unless the patient is on full dose warfarin)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
* Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent
* Negative serum pregnancy test done =< 7 days prior to registration, for women of childbearing potential only; NOTE: patients and their partners should be practicing an effective form of contraception during the study and for at least 3 months following the last dose of this combined therapy
* Full-dose anticoagulants, if a patient is receiving full-dose anticoagulants (except carcinoid tumors), the following criteria should be met for enrollment: the subject must have an in-range INR (usually between 2 and 3) on a stable dose of warfarin or on stable dose of low molecular weight (LMW) heparin
* Prior systemic treatments for metastatic disease are permitted, including targeted therapies, biologic response modifiers, chemotherapy, hormonal therapy, or investigational therapy; exception: in the case of endometrial cancer no prior chemotherapy for metastatic or recurrent disease is allowed; prior planned adjuvant chemotherapy is allowed
* Patients who have had prior anthracycline must have a normal ejection fraction on left ventricular ejection fraction (LVEF) assessment by multigated acquisition scan (MUGA) or echocardiogram (Echo) =< 4 weeks prior to registration
* Availability of tissue if applicable (from the primary tumor or metastases) for tumor studies for banking; Note: in the case of hepatocellular cancer if diagnosed by clinical and radiologic criteria only, availability of tissue not applicable
* Willingness to donate blood for biomarker studies related to the type of therapies used in this trial and the tumor types being treated
* ENDOMETRIAL CANCER (PERMANENTLY CLOSED TO ENROLLMENT)
* Any hormonal therapy directed at the malignant tumor is allowed; NOTE: therapy must be discontinued at least one week prior to registration
* Prior systemic therapy including biologic and immunologic agents as adjuvant treatment, must be discontinued at least 3 weeks prior to registration
* Recurrent or persistent endometrial adenocarcinoma, uterine papillary serous carcinoma and carcinosarcoma which is refractory to curative therapy or established treatments; NOTE: histologic or cytologic confirmation of original primary tumor is required
* HEPATOCELLULAR CANCER (PERMANENTLY CLOSED TO ENROLLMENT)
* HCC confirmed by biopsy OR diagnosed by clinical and radiologic criteria; all of the following criteria must be met or a biopsy is required:
* Known cirrhosis or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
* Hypervascular liver masses > 2 cm, and either serum alpha-fetoprotein (AFP) > 400 ng/ml, or
* AFP > three times normal and doubling in value in the antecedent 3 months
* Child-Pugh A (=< 6 points) or better liver status
* Prior regional treatments for liver metastasis are permitted including:
* Selective internal radiation therapy such as brachytherapy, cyberknife, radiolabeled microsphere embolization, etc.
* Hepatic artery chemoembolization
* Hepatic artery embolization
* Hepatic artery infusional chemotherapy
* Radiofrequency ablation NOTE: patients must be >= 4 weeks from treatment and show progressive disease in the liver after regional therapy or must have measurable disease outside the liver
* Concomitant anti-viral therapy is allowed
* History of prior varices or evidence of varices on pre-study CT/magnetic resonance imaging (MRI) imaging are required to undergo endoscopy =< 4 weeks prior to registration; those who had received specific therapy (banding and/or sclerotherapy) and had not bled within the prior 6 months are eligible
* Suitably recovered from prior localized therapy, in the opinion of the investigator
* ISLET CELL CANCER AND CARCINOID TUMOR (PERMANENTLY CLOSED TO ENROLLMENT)
* Patient has evidence of progressive disease as documented by Response Evaluation Criteria in Solid Tumors (RECIST) =< 7 months prior to study entry
* Carcinoid tumor cohort: prior and concurrent long-acting somatostatin analogue therapy is required; patient has to be on a stable dose of a long-acting somatostatin analogue >= 2 months prior to study entry with documentation of progressive disease on current dose
* Islet cell tumor cohort: prior and/or concurrent long-acting somatostatin analogue therapy is allowed, but not required; if patient is continued on a long-acting somatostatin analogue, a stable dose for >= 2 months prior to study entry is required with documentation of progressive disease on current dose
* Prior therapies allowed include:
* =< 2 prior chemotherapy regimens
* Prior interferon >= 4 weeks prior to registration
* Radiolabeled octreotide therapy (patients with prior radiolabeled octreotide therapy should have progressive disease after such therapy)
* Other investigational therapy NOTE: islet Cell Single Agent Bevacizumab Cohort: Prior mammalian target of rapamycin (mTOR) inhibitor is allowed
* Prior regional treatments for liver metastasis are permitted including:
* Selective internal radiation therapy such as brachytherapy, cyberknife, radiolabeled microsphere embolization, etc.
* Hepatic artery chemoembolization
* Hepatic artery embolization
* Hepatic artery infusional chemotherapy
* Radiofrequency ablation NOTE: patients must be >= 12 weeks from treatment and show progressive disease in the liver after regional therapy or must have measurable disease outside the liver
Exclusion Criteria:
* Prior therapy with vascular endothelial growth factor receptor (VEGFR) targeting agents or mammalian target of rapamycin (mTOR) inhibitors (except as in HCC and in the Islet cell single agent bevacizumab alone cohort where prior mTOR inhibitor is allowed); Note: prior use of bevacizumab is not allowed in any cohort
* Invasive procedures defined as follows:
* Major surgical procedure, open biopsy or significant traumatic injury =< 4 weeks prior to registration
* Anticipation of need for major surgical procedures during the course of the study
* Core biopsy =< 7 days prior to registration
* Serious or non-healing wound, ulcer or bone fracture
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess =< 180 days prior to first date of bevacizumab therapy
* Evidence of bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
* Evidence of a history bleeding =< 6 months such as hemoptysis, or cerebrovascular accident =< previous 6 months, or peripheral vascular disease with claudication on < 1 block, or history of clinically significant bleeding, because of the potential bleeding and/or clotting risk with bevacizumab
* Untreated central nervous system (CNS) metastases; exceptions: patients with known CNS metastases can be enrolled if the brain metastases have been adequately treated and there is no evidence of progression or hemorrhage after treatment as ascertained by clinical examination and brain imaging (MRI or CT) =< 12 weeks prior to registration and no ongoing requirement for steroids
* Anticonvulsants (stable dose) are allowed
* Patients who had surgical resection of CNS metastases or brain biopsy =< 3 months prior to registration will be excluded
* Significant cardiovascular disease defined as congestive heart failure (New York Heart Association class II, III or IV), angina pectoris requiring nitrate therapy, or recent myocardial infarction (=< 6 months prior to registration)
* Uncontrolled hypertension (defined as a blood pressure of >= 150 mmHg systolic and/or >= 90 mmHg diastolic)
* Patient is on angiotensin-converting-enzyme (ACE) inhibitors (benazapril, captopril, enalopril, fosonopril, lisinopril, moexipril, perindopril, quinopril, ramipril, and trandolapril); (patients may have an alternate antihypertensive substituted); NOTE: ACE inhibitors are allowed in single agent bevacizumab cohort
* Currently active, second malignancy other than non-melanoma skin cancers; NOTE: patients are not considered to have a 'currently active' malignancy if they have completed anti-cancer therapy and are considered by their physician to be at less than 30% risk of relapse
* Any of the following, as this regimen may be harmful to a developing fetus or nursing child:
* Pregnant women
* Breastfeeding women
* Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) NOTE: the effects of the agent(s) on the developing human fetus at the recommended therapeutic dose are unknown
* Known hypersensitivity to other recombinant human antibodies or Chinese hamster ovary cell products
* Other uncontrolled serious medical or psychiatric condition (e.g. cardiac arrhythmias, diabetes, etc.)
* Current therapy with a cytochrome P450 3A4 (CYP3A4) inhibitor or inducer; NOTE: these agents are allowed in the single-agent bevacizumab islet cell carcinoma cohort
* Active infection requiring antibiotics
* Active bleeding or pathological conditions that carry high risk of bleeding (e.g. tumor involving major vessels, known varices)
* Known human immunodeficiency virus (HIV)-positive
* ENDOMETRIAL CANCER (PERAMANENTLY CLOSED TO ENROLLMENT)
* Received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of endometrial cancer
* Any chemotherapy for metastatic or recurrent cancer
* Radiation therapy to > 25% of marrow bearing areas
* HEPATOCELLULAR CANCER EXCLUSION (PERMANENTLY CLOSED TO ENROLLMENT)
* Child-Pugh B or C classification
* Grade >= 3 hemorrhage =< 4 weeks prior to registration
* Prior liver transplant with evidence of recurrent or metastatic disease
* Patients on an active liver transplant list and considered likely to receive a liver transplant =< 6 months following registration
* Clinical evidence of encephalopathy
* Prior treatment with sorafenib or other vascular endothelial growth factor (VEGF) inhibitors; NOTE: Exceptions allowed for patients unable to tolerate the agent; intolerance is defined in this protocol as a discontinued agent due to side effects with an exposure < to 4 weeks of drug, at any dose level
* OVARIAN CANCER (PERMANENTLY CLOSED TO ENROLLMENT)
* Clinical signs and symptoms of gastrointestinal (GI) obstruction and require parental hydration/nutrition or tube feeding
* Evidence of free abdominal air not explained by paracentesis or recent surgical procedures
* Received more than two prior cytotoxic chemotherapy regimens for persistent or recurrent disease
* CARCINOID (PERMANENTLY CLOSED TO ENROLLMENT)
* Patients on anticoagulant therapy
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Study Objectives
The aim of this trial is to evaluate the differences in pain relief, neurological function, quality of life and survival in patients with metastatic epidural spinal cord compression (MESCC) who are managed with a combination of surgery and radiotherapy versus radiotherapy alone.
Further we shall evaluate cost-effectiveness of the two treatment approaches.
Intervention / Treatment
PROCEDURE: Surgical excision of the metastatic process, RADIATION: Radiotherapy of the metastatic spine process
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Inclusion Criteria:
* Single symptomatic metastatic epidural spinal compression at any level confirmed by MRI
* Age 18 and more
* Able and willing to give written informed consent to participate in the study
* Able to read and write English on an elementary level
Exclusion Criteria:
* Multiple symptomatic spinal metastases
* Radiosensitive tumors
* Radioresistant tumors
* Primary cancer site in CNS or spine
* Poor life expectancy (< 3 months)
* Patients with a tumor that has compressed only the cauda equina or spinal roots
* Has a recent history of substance abuse
* Is a prisoner
* Currently involved in another study
* has a disease or condition that would preclude accurate evaluation
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Study Objectives
This randomized phase II trial studies how well giving decitabine with or without bortezomib works in treating older patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells,by stopping them from dividing, or by stopping them from spreading. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether decitabine works better when given with or without bortezomib in treating acute myeloid leukemia.
Intervention / Treatment
DRUG: Bortezomib, DRUG: Decitabine, OTHER: Laboratory Biomarker Analysis, OTHER: Pharmacological Study, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
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Inclusion Criteria:
* Unequivocal pathologic diagnosis of AML (>= 20% blasts in the bone marrow based on World Health Organization \[WHO\] criteria) EXCLUDING:
* Acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA
* Acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1 as determined by the Ohio State University (OSU) Molecular Reference Laboratory, per Cancer and Leukemia Group B (CALGB) 20202; however patients who * are >= 75 years; and/or * have an ejection fraction of < 40%; and/or * have a performance status of > 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and core-binding factor (CBF) molecular screening results from CALGB 20202
* Acute myeloid leukemia with inv*(p*1;q22) or t(16;16)(p*1;q22); CBFB-MYH11 as determined by the OSU Molecular Reference Laboratory, per CALGB 20202; however patients who * are >= 75 years; and/or * have an ejection fraction of < 40%; and/or * have a performance status of > 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and CBF molecular screening results from CALGB 20202
* Absence of FLT3 mutation (ITD or point mutation) determined by the OSU Molecular Reference Laboratory, per CALGB 20202; however patients who * are >= 75 years; and/or * have an ejection fraction of < 40%; and/or * have a performance status of > 2, may be registered to CALGB 20202 and registered and treated on CALGB 11002 prior to receiving the FLT3 mutation and CBF molecular screening results from CALGB 20202
* No prior treatment for AML except:
* Emergency leukapheresis
* Emergency treatment for hyperleukocytosis with hydroxyurea
* Cranial radiotherapy (RT) for central nervous system (CNS) leukostasis (one dose only)
* Growth factor/cytokine support
* AML patients with an antecedent hematologic disorder (AHD) or myelodysplastic syndrome (MDS) are eligible for this trial provided that they have not received treatment for their AHD or MDS with cytotoxic chemotherapy (e.g., cytarabine, daunorubicin, etc.), decitabine, or bortezomib; patients may have been previously treated with azacitidine if their last dose was >= 90 days prior to starting 11002
* AML patients with therapy-related myeloid neoplasms (t-MN) are eligible if they have not received radiation therapy or chemotherapy (not including hormonal therapy) for their primary malignancy or disorder for > 6 months
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Study Objectives
Mesenchymal stem cells (MSCs) are present in the circulation of cancer patients, and are recruited to the stroma of both the primary tumor and metastasis. Recent preclinical research has shown that in response to platinum-based chemotherapy, MSCs secrete two specific platinum-induced fatty acids (PIFAs) which induce resistance to a broad spectrum of chemotherapies. The secreted PIFAs are the fatty acid oxo-heptadecatetraenoic acid (KHT) and the omega-3 fatty acid hexadecatetraenoic acid (16:4). These PIFAs are produced via the COX-1 pathway. COX inhibitors, including indomethacin. This phase 1 study explores the safety of combining indomethacin with platinum containing chemotherapy.
Intervention / Treatment
DRUG: Indomethacin
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Inclusion Criteria:
* Subjects with a histological proven malignancy receiving cisplatin combined with gemcitabine or 5FU/capecitabine. (cisplatin dose range 60-80 mg/m2) (Arm I) or CAPOX (oxaliplatin, capecitabine) (Arm II) in a 21 day cycle.
* Age ≥ 18 years
* Platinum-based chemotherapy naïve for at least 6 months.
* Subjects with at least one evaluable lesion.
* WHO Performance Status of 0 or *
* Female participants should be of non-child bearing potential either physiologic or by using adequate contraception, have a negative serum pregnancy test, and refrain from breast feeding.
* Written informed consent.
Exclusion Criteria:
* Known or suspected allergy or hypersensitivity to indomethacin or any agent given in association with this trial, in particular subjects who have a history of severe hypersensitivity reactions to anti-emetics (5-HT3 antagonists, metoclopramide or corticosteroids) and acetylsalicylic acid or other prostaglandin synthetase inhibitors.
* Symptomatic brain or meningeal tumors
* Subjects with seizure disorder requiring medication (such as corticosteroids or anti-epileptics).
* Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study:
* Uncontrolled high blood pressure, history of labile hypertension, or history of poor compliance with an antihypertensive regimen
* Unstable angina pectoris
* Symptomatic congestive heart failure NYHA class ≥ 3 (see appendix *6)
* Myocardial infarction ≤ 6 months prior to randomization
* Serious uncontrolled cardiac arrhythmia
* Active peptic ulcer disease, gastritis, inflammatory bowel disease.
* History of active gastrointestinal bleeding
* History of cerebrovascular disease
* Bleeding diathesis
* Chronic renal disease defined as GFR (MDRD) <60 ml/min
* Absolute Neutrophil Count (ANC) < *5 x 109/L (< 1500/mm3)
* Platelets (PLT) < 100 x 109/L (< 100,000/mm3)
* Hemoglobin (Hgb) < *0 mmol/l (patients may be transfused to achieve adequate Hb)
* Partial thromboplastin time (PTT) > 1,5 x ULN
* Serum bilirubin > *5 ULN
* Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) > *0 x ULN (> 5 x ULN if liver metastases present)
* Patients who are unable or unwilling to comply with the protocol
* Chronic treatment with a corticosteroid agent (nebulized corticosteroids are allowed)
* Patients who received radiation therapy within 4 weeks of the start of the study
* Patients who received an experimental agent less than 4 weeks before start of the study.
* Patients who used Omega-3/omega-6 containing products, including fish oil products less than 2 weeks before start of the study.
* Chronic use of NSAID's and/or acetylsalicylic acid and/or other prostaglandin synthetase inhibitors.
* Use of anticoagulant therapy
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Study Objectives
This study will assess cognitive function in adult patients with a primary brain tumour treated with surgical resection with or without radiation therapy (RT). All types of brain tumours apart from glioblastoma will be included
Intervention / Treatment
RADIATION: Cognitive testing
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Inclusion Criteria:
* The participant must be 18 years or older and Danish speaking.
* Performance status 0-2
* Capable of cooperating on testing
* Diagnosed with one of the following diagnoses according to WHO 2016 classification 16 and been treated between 2006 and 2016
* ZM93803 glioma (exclusive glioblastoma)
* ZM9401/3 anaplastic astrocytoma, IDH mutant
* ZM9400/3 diffuse astrocytoma, IDH-mutant
* ZM9411/3 gemistocytisk astrocytoma, IDH mutant
* ZM9400/3 diffuse astrocytoma, NOS
* ZM9451/3 anaplastic oligodendroglioma, IDH mutant and 1p/19q-co deleted
* ZM9450/3 oligodendroglioma, IDH mutant and 1p/19q-co deleted
* ZM9450/3 oligodendroglioma, NOS
* ZM9451/3 anaplastic oligodendroglioma, NOS
* ZM9530/0 meningioma
* ZM9470/3 medulloblastoma, NOS
* DD352A pituitary adenoma
* Other rare brain tumours including skull base sarcomas
-
Exclusion Criteria:
Performance status 3-4 Progression after radiation therapy
-
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Study Objectives
The purpose of the pilot is to test the feasibility of developing and implementing the Williams LifeSkills Cancer Care (WLSCC) and examining its preliminary impact on caregiver well-being and patient well-being. The study is a two-arm randomized intervention pilot (WLSCC vs. Usual Care \[UC\]) with data collection at baseline, immediately after training, and 2 weeks after completing the training. Study setting is at the breast and thoracic cancer clinics at the Duke Cancer Clinic. A total of 40 cancer patients (20 breast cancer patients and 20 lung cancer patients) and their caregivers (for a total N of 80) will be recruited for the pilot. The WLSCC will involve six 30-minute phone sessions and will encompass the application of 10 psychosocial skills within the context of cancer caregiving. Descriptive statistics will be used to detail recruitment/retention rate, fidelity rate, and the baseline demographic and clinical characteristics for the total sample and each group. Plots of the individual trajectories (within-person scores over time) will be used to identify the pattern(s) of change over time, and assess between-person variability in baseline values (intercepts) and trajectories (slopes). This study carries minimal risk to study participation.
Intervention / Treatment
BEHAVIORAL: WLSCC, OTHER: Usual Care
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Inclusion Criteria:
* Patients are those with a confirmed medical diagnosis of breast or thoracic cancer regardless of stage and followed at DCC for management.
* The cancer diagnosis should have been made less than a year from the next scheduled appointment to the DCC.
* The caregiver is defined as unpaid individuals involved in assisting the cancer patient with activities of daily living and/or medical tasks.
* Patients and caregivers must be able to hear, read, and write in English; oriented to place, person, and time; and have an active telephone service, either cellular or landline.
Exclusion Criteria:
* Excluding patients and caregivers who are less than 18 years of age
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Study Objectives
This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and Rituximab in subjects with CLL.
Intervention / Treatment
DRUG: CC-292, DRUG: Rituximab
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Inclusion Criteria:
* Male and female subjects 18 years of age and older at the time of signing the informed consent document.
* Understand and voluntarily sign an informed consent document (ICD) prior to any study related assessments/procedures being conducted.
* Able to adhere to the study visit schedule and other protocol requirements.
* Body weight ≥ 50 kg.
* Must have a documented diagnosis of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (International Workshop) guidelines for the diagnosis and treatment of CLL (Appendix A), or lymphoma guidelines (Appendix B) for diagnosis and treatment of SLL by investigator assessment.
* Have failed ≥ 1 previous treatments for CLL/SLL, and have relapsed or refractory disease following last prior treatment.
* Refractory is defined as CLL/SLL that does not achieve at least a partial response (PR) to therapy or that progresses within 6 months of treatment. Relapsed CLL/SLL refers to disease that progresses after ≥ 6 months in subjects who had achieved a PR or complete response (CR) to therapy.
* Subjects must have failed, refused, be ineligible, or not otherwise appropriate, per the investigator's judgment, for autologous stem cell transplant (SCT) unless enrollment in this study is anticipated to debulk lesions in preparation for SCT.
* Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤ 2
* Life expectancy of at least 3 months form the time of signing the ICD.
* Females of childbearing potential (FCBP)must have a negative medically supervised pregnancy test prior to starting of study therapy.
* Male subjects must:
* Agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug treatment, during any dose interruption and for 28 days after end of study therapy.
* Agree to not donate semen during study drug treatment and for 28 days after end of study drug treatment.
* Ability to swallow oral capsules without difficulty.
* Have an echocardiogram or multigated acquisition scan of the heart demonstrating left ventricular ejection fraction (LVEF) ≥ 50% or the institution's lower limit of normal.
* Have recovered from adverse, toxic effects of prior therapies to Grade ≤ 1 National Cancer Institute Common Terminology Criteria for Adverse Events (NCI/CTCAE) version *03 except for alopecia and peripheral neuropathy. This requirement will be subordinate to specific clinical and laboratory criteria that are otherwise specifically addressed in these inclusion/exclusion criteria.
Exclusion Criteria:
* Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
* Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
* Any condition that confounds the ability to interpret data from the study.
* Autologous stem cell transplant within 3 months of screening date.
* Uncontrolled intercurrent illness including, but not limited to:
* Ongoing or active infection requiring parenteral antibiotics.
* Uncontrolled diabetes mellitus as defined by the investigator.
* Chronic symptomatic congestive heart failure (Class III or IV of the New York Heart. Association Classification for Heart Disease; AppendixG).
* Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months of signing the ICD.
* Clinically significant cardiac arrhythmia that is symptomatic or requires treatment, or asymptomatic sustained ventricular tachycardia. Subjects with controlled atrial fibrillation that is asymptomatic are eligible.
* Pregnant or lactating females.
* Prior history of malignancies, unless the subject has been free of the disease for ≥ 3 years of signing the informed consent. Exceptions to the ≥ 3 year time limit include history of the following:
* Basal cell carcinoma of the skin.
* Squamous cell carcinoma of the skin.
* Carcinoma in situ of the cervix.
* Carcinoma in situ of the breast.
* Carcinoma in situ of the bladder.
* Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b). (The TNM staging system is based on the extent of the tumor (T), whether cancer cells have spread to nearby (regional) lymph nodes (N), and whether distant (to other parts of the body) metastasis (M) has occurred).
* Known seropositivity for or history of active viral infection with Human Immunodeficiency Virus (HIV).
* Seropositive for or active viral infection with Hepatitis B virus (HBV):
* HBV surface antigen positive.
* HBV surface antigen negative, HBV surface antibody positive and/or HBV core antibody positive and detectable viral deoxyribonucleic acid (DNA).
Note: Subjects who are HBV surface antigen negative and viral DNA negative are eligible.
* Subjects who had HBV but have received an antiviral treatment and show no detectable viral DNA within 6 months of signing the ICD are eligible.
* Subjects who exhibit the classical vaccination profile of HBV surface antibody positive, HBV core antibody negative, and HBV surface antigen negative are eligible.
* Known seropositivity for or active viral infection with Hepatitis C virus (HCV).
* Subjects who are at a high risk for a thromboembolic event and are not willing to take venous thromboembolic event (VTE) prophylaxis.
* Any of the following laboratory abnormalities:
* Absolute neutrophil count (ANC) ≤ 1,000 cells/mm3 (*0 x 109/L) unless secondary to bone marrow involvement by lymphoma as demonstrated by recent bone marrow aspiration and bone marrow biopsy.
* Platelet count ≤ 50,000/mm3 (50 x 109/L) unless secondary to bone marrow involvement by lymphoma as demonstrated by recent bone marrow aspiration and bone marrow biopsy. Note that growth factors or transfusions should not be administered during screening for the sole purpose of helping a subject exceed these exclusionary laboratory values.
* Serum Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) or Alanine Transaminase/Serum Glutamic Pyruvate Transaminase (ALT/SGPT) > *0 x Upper Limit of Normal (ULN) or > *0 x ULN in cases of documented liver involvement by lymphoma.
* Serum bilirubin > *5 x ULN or > *0 x ULN in cases of Gilbert's Syndrome and documented liver involvement by lymphoma.
* Calculated creatinine clearance using the Cockcroft-Gault formula (Cockcroft, 1976).
* For subjects enrolling in Part 1 creatinine clearance value must be < 30 mL/min
* For subjects enrolling in Part 2 creatinine clearance value must be < 60 mL/min
* Corrected QT interval (QTc) prolongation (defined as a QTc > 450 msec for males and > 470 msec for females \[Fridericia's correction\] echocardiograms (ECGs) or other clinically significant ECG abnormalities as assessed by the investigator. An average of 3 QTc intervals may be obtained if necessary.
* Evidence of Tumor Lysis Syndrome (TLS) per the Cairo-Bishop definition of laboratory TLS (\[Appendix F\] subjects may be enrolled upon correction of electrolyte abnormalities).
* Prior exposure to Bruton Tyrosine Kinase inhibitors.
* Chemotherapy, radiotherapy, investigational anti cancer therapy or major surgery within 28 days of Day 1 dosing.
* Use of systemic corticosteroids in doses greater than prednisone equivalent 20 mg/day within 3 weeks prior to the first dose of study drug treatment.
* Concomitant use of medicines known to cause QT prolongation or torsades de pointes (Appendix I).
* Chronic use of H2 antagonists or proton pump inhibitors or their use within 7 days of first dose of study drug treatment. Subjects with chronic gastroesophageal reflux disease, dyspepsia, and peptic ulcer disease, should be carefully evaluated for their suitability for this treatment prior to enrollment in this study.
* Gastrointestinal abnormalities including the ability to take oral medication, require intravenous (IV) alimentation, or prior surgical procedures affecting absorption.
* History of hypersensitivity reaction to Rituximab.
* Any vaccinations incorporating the use of a live vaccine within 3 weeks from first dose.
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Study Objectives
The purpose of this study is to learn about how to provide treatment to cancer survivors who have difficulty sleeping.
Intervention / Treatment
BEHAVIORAL: Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference
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Inclusion Criteria:
* Located in the Southern Puerto Rico area
* Able to speak and read Spanish
* Have no documented or observable disabilities that would interfere with study participation
* Has completed primary treatment for breast cancer (e.g., surgery, chemotherapy, radiation)
* Has clinically significant sleep disturbance (i.e., >/= 8 on the Insomnia Severity Index)
* Is at low risk of other sleep disorders that are not amenable to treatment with cognitive-behavioral therapy
* Has access to the Internet and a digital device (e.g., smartphone) capable of using videoconference software
Exclusion Criteria:
* Not able to read and speak Spanish
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Study Objectives
The purpose of this study is to evaluate the diagnostic performance of \[18F\]CTT1057 as a PET imaging agent for detection and localization of PSMA positive tumors using histopathology as Standard of Truth (SoT). Tissue specimens from both the primary tumor and pelvic lymph nodes dissected during surgery from patients with newly-diagnosed high-risk prostate cancer (PCa) will be used for the histopathology assessments.
Approximately 195 participants will be enrolled to ensure that at least 156 participants are evaluable (i.e. have both an evaluable PET/CT scan and histopathology assessment and have not received any prohibited systemic antineoplastic therapy before the completion of PET/CT and surgery), which will be required for the calculation of the co-primary endpoints.
Intervention / Treatment
DRUG: [18F]CTT1057
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Inclusion Criteria:
* Untreated high risk biopsy-proven PCa patients according to D'Amico classification (Stage ≥ T2c or PSA level >20ng/ml or Gleason score ≥8) (D'Amico et al 1998)
* Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
* ECOG performance status 0-2
* Signed informed consent must be obtained prior to participation in the study
* Participants must be adults ≥ 18 years of age
Exclusion Criteria:
* Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
* Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and COVID-*
* Known allergy, hypersensitivity, or intolerance to \[18F\]CTT1057
* Prior and current use of PSMA targeted therapies
* Prior and current treatment with any ADT (first or second generation), including LHRH analogues (agonists or antagonists)
* Any 5-alpha reductase inhibitors within 30 days before screening
* Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
* Patients with incidental PCa after transurethral resection
* Use of other investigational drugs within 30 days before screening
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Study Objectives
* Design: non-randomized, open label, phase II clinical trial.
* Study population and disease: adult patients with metastatic or locally advanced non-resectable adrenocortical carcinoma, confirmed histologically.
* Estimated number of patients: 15.
* Study drug: dovitinib (TKI-258), dosed on a flat scale of 500mg/day on a 5 days on / 2 days off.
* Treatment duration: study treatment period will be continued until disease progression, unacceptable toxicity, death or premature withdrawal from study. An average of 6 months treatment period is expected.
* Study duration: expected recruitment period will be 18 months, and patients will be followed for 6 additional months after last patient is included in the trial.Study total expected duration is 24 months.
* Sites: the study is planned to be conducted in 7 Spanish centers.
Intervention / Treatment
DRUG: Dovitinib
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Inclusion Criteria:
* Male or female patients aged ≥ 18 years old
* A performance status of 0, 1, or 2, according to the Eastern Cooperative Oncology Group (ECOG) scale.
* Histologically confirmed adrenocortical carcinoma.
* Metastatic or locally advanced non-resectable disease.
* At least one radiologically measurable lesion, according to RECIST **
* Adequate liver function as shown by: serum or plasma ALT and AST ≤ *0 x ULN (regardless of the presence or absence of metastases)and serum or plasma total bilirubin: ≤ *5 x ULN.
* Adequate bone marrow function as shown by: blood absolute neutrophil count (ANC) ≥ *5 x 109/L, platelets ≥ 100 x 109/L and hemoglobin (Hb) > 9g/dL.
* Adequate renal function as shown by serum creatinine ≤ *5 x ULN.
* Patients give a written informed consent obtained according to local guidelines.
Exclusion Criteria:
* Prior chemotherapy other than mitotane (Patients who have previously received mitotane will only be eligible if drig has been withdrawn at least two weeks earlier than dovitinib first dose is administered).
* Patients with another primary malignancy within 3 years prior to starting the study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or completely excised basal or squamous cell carcinoma of the skin.
* Patients who have received radical radiotherapy ≤4 weeks prior to starting the study treatment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy for bone lesions ≤2 weeks prior to starting study treatment is allowed.
* Patients who have undergone any major surgery (i.e., intra-thoracic, intrabdominal, or intra-pelvic) ≤4 weeks prior to starting study treatment or who have not recovered from side effects of such therapy.
* Patients with a history of pulmonary embolism (PE) within the past 6 months or untreated deep-venous-thrombosis (DVT) within the past 6 months. Adequately treated DVT will be permitted providing that patient has been on anticoagulation for at least 2 weeks.
* Patients with impaired cardiac function or clinically significant cardiac diseases, including any of the following:
* History or presence of serious uncontrolled ventricular arrhythmias.
* Clinically significant resting bradycardia.
* LVEF <45% when assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition scan (MUGA). (No basal cardiac test is mandatory other than ECG)
* Any of the following within 6 months prior to starting study treatment: Myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF),Cerebrovascular Accident (CVA), Transient Ischemic Attack TIA).
* Uncontrolled hypertension defined by a SBP ≥160 mm Hg and/or DBP ≥100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to study entry.
* Patients with impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Dovitinib (TKI258) (i.e., severe ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or extensive (>1m) small bowel resection, inability to swallow oral medications). Prior partial or total gastrectomy is not an exclusion criterion.
* Known diagnosis of human immunodeficiency virus (HIV) infection. HIV testing is not mandatory.
* Patients who are currently receiving full dose of anticoagulation treatment with therapeutic doses of dicumarinical drugs as warfarin/acenocoumarol or anti-platelet therapy (i.e.,clopidogrel bisulfate). Treatment with acetylsalicyclic acid 100mg daily is allowed, as well as prophylactic or therapeutic low-weight-heparin.
* Pregnant or breast-feeding women.
* Women of child-bearing potential not employing an effective method of birth control. Effective contraception (e.g. condom with spermicidal jelly, foam suppository or film; diaphragm with spermicide; male condom and diaphragm with spermicide) must be used throughout the trial and 8 weeks after the end of Dovitinib treatment. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Women of child-bearing potential defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months), must have a negative serum pregnancy test ≤ 14 days prior to starting study drug. Women of child-bearing potential not employing and not willing to use an effective method of birth control. Post-menopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
* Fertile males not willing to use contraception as stated above.
* Patients unwilling or unable to comply with the protocol.
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Study Objectives
This multicenter open labeled phase 2 trial examines the efficacy of a combination of Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min) and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal cancer. The combination was considered to be suitable for further evaluation with a freedom of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable patients were needed based on a 2-Stage Simon design with a first evaluation after 25 evaluable patients.
Intervention / Treatment
DRUG: Gemcitabine, DRUG: Cisplatin, DRUG: 5-FU, DRUG: Folinic Acid
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Inclusion Criteria:
* Age>=18
* Histologically proven inoperable esophageal cancer
* Karnofsky Performance status >=60%
* Estimated life expectancy of > 12 weeks
* Measurable disease
* No other oncologic therapy
* Measurable disease
* Adequate bone marrow function
* Geographic proximity and compliance
* Informed consent
* Negative pregnancy test and adequate contraception
Exclusion Criteria:
* Insufficient hepatic or renal function
* Elevated serum calcium
* Pregnancy/breast feeding
* Active infection
* Other malignancies
* Systemic tumour complications requiring emergency interventions
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Study Objectives
The purpose of this study is to find out if the combination of bortezomib (Velcade), dexamethasone (Decadron) and rituximab (Rituxan) is effective in treating Waldenstrom's macroglobulinemia.
Intervention / Treatment
DRUG: Bortezomib, DRUG: Dexamethasone, DRUG: Rituximab
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Inclusion Criteria:
* Clinicopathological diagnosis of Waldenstrom's macroglobulinemia (WM)
* No previous therapy for WM
* Measurable disease, defined as presence of immunoglobulin M (IgM) paraprotein with a minimum IgM level of greater than or equal to 2 times the upper limit of each institution's normal value
* CD20 positive disease based on any previous bone marrow immuno-histochemistry or flow cytometric analysis performed up to 3 months prior to enrollment
* Karnofsky performance status > 60
* Life expectancy > 3 months
* AST (SGOT) < 3 x ULN
* ALT (SGPT) < 3 x ULN
* Total bilirubin < 2 x ULN
* Calculated or measured creatinine clearance > 30mL/minute
* Serum sodium > 130 mmol/L
* Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
* Male subject agrees to use an acceptable method for contraception for the duration of the study
Exclusion Criteria:
* Previous therapy for Waldenstrom's macroglobulinemia
* Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
* Hypersensitivity to dexamethasone, boron or mannitol
* Pregnant or breast-feeding women
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
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Study Objectives
The goal of this clinical research study is to learn if the combination of clofarabine, idarubicin, and cytarabine, or the combination of fludarabine, idarubicin, and cytarabine can help control Acute myeloid leukemia (AML) and Myelodysplastic syndromes (MDS). The safety of these study drug combinations will also be studied.
Intervention / Treatment
DRUG: Clofarabine, DRUG: Idarubicin, DRUG: Cytarabine, DRUG: Fludarabine
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Inclusion Criteria:
* Sign an Institutional Review Board (IRB)-approved informed consent document.
* Age 18 to * Patients above the age of 60 only with principal investigator (PI) approval
* Diagnosis of newly diagnosed AML \[other than acute promyelocytic leukemia (APL)\] or high-risk (intermediate-2 or high by International Prostate Symptom Score (IPSS) or > 10% blasts, including CMML) MDS. Prior therapy with hydrea and the use of a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use up to 24 hours prior to start of study therapy is allowed. Prior therapy for MDS or other AHD is not allowed.
* Eastern Cooperative Oncology Group (ECOG) performance status of </= 3 at study entry.
* Organ function as defined below (unless due to leukemia): Serum creatinine </= 3 mg/dL Total bilirubin </= *5 mg/dL , Alanine aminotransferase (ALT) (SGPT) </= 3 \* upper limit of normal (ULN) or </= 5 \* ULN if related to disease.
* Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days and must agree to practice acceptable contraceptive methods. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
* Cardiac ejection fraction >/= 40% (by either cardiac echo or multiple gated acquisition scan (MUGA) scan). Documentation of recent (</= 6 months from screening) outside reports is acceptable.
Exclusion Criteria:
* Breast feeding females
* Patients with uncontrolled active infections (viral, bacterial, and fungal are not eligible).
* Patients with active secondary malignancy will not be eligible.
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Study Objectives
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.
Intervention / Treatment
DRUG: Trastuzumab for injection, DRUG: Herceptin
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Inclusion Criteria:
* Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration;
* Healthy male subjects aged ≥ 18 years and ≤ 65 years;
* Body weight ≥ 50 kg ≤ 90 kg, body mass index ≥ 18 ≤ 28kg/m2;
* The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance;
* Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion.
Exclusion Criteria:
* History of hypertension or abnormal blood pressure at screening/baseline measurement;
* A history of albuminuria or albuminuria as assessed by the investigator as clinically significant;
* Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year;
* Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months;
* Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding;
* History of digestive tract perforation or digestive tract fistula;
* Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion;
* Use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use;
* Positive virology test;
* Known allergy to trastuzumab;
* Known history of allergic diseases or allergic constitution;
* Study the history of blood donation 3 months before drug infusion;
* Received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening
* A history of alcohol or drug abuse in the 12 months prior to screening;
* A history of mental illness;
* Subjects whose spouses plan to become pregnant;
* The study cannot be completed according to protocol requirements during the study period;
* Conditions considered unsuitable for inclusion by other researchers.
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Study Objectives
The aim of the study is to evaluate the efficacy of TARGIN administration as an analgesic to Korean patients treated with opioid analgesics for moderate-to-severe cancer pain under conditions of daily practice.
Intervention / Treatment
DRUG: Oxycodone/Naloxone
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Inclusion Criteria:
* Male or female cancer patients 20 years of age or older
* Cancer related pain that requires treatment with continuous around-the-clock strong opioid analgesic
* Moderate to severe pain intensity (NRS pain score >=4)
* Opioid naïve patients or patients not treated with strong opioids (Only except occasional PRN) within 13 months or patients who has been on weak opioids
* Ability to communicate effectively with the study personnel regarding pain intensity, constipation assessment, final assessment of overall efficacy and tolerability
* Subject who provide signed and dated written voluntary informed consent
Exclusion Criteria:
* Pregnant or nursing (lactating) women
* Have previously received treatment with Targin
* Patient with evidence of significant structural/functional abnormalities of GI tract which is not appropriate for oral medicine administration
* Any history of hypersensitivity to Oxycodone and Naloxone or any excipients
* Patients with significant respiratory depression
* Patients with acute or severe bronchial asthma or hypercarbia
* Any patient who has or is suspected of having paralytic ileus
* Severe Chronic obstructive pulmonary disease, pulmonary heart disease
* Targin product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take
* Patients with moderate and severe hepatic impairment
* Abnormal aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels (>*5 times the upper limit of normal, it is allowed >5 times the upper limit of normal in case of transition in liver) or an abnormal total bilirubin and/or creatinine level(s) (greater than *5 times the upper limit of normal)
* Any situation where opioids are contraindicated
* With a life expectancy < 1 month
* Any situation where opioids are contraindicated
* Mainly pain originated other than cancer or cancer related conditions (eg. Musculoskeletal pain, inflammatory pain, diabetic polyneuropathy)
* Patients with known or suspected unstable brain metastases or spinal cord compression that may require changes in steroid treatment throughout the duration of the study
* Patients with uncontrolled seizures
* Requiring interventional treatment for pain such as neurodestructive procedure or regional infusion
* With a history of alcohol abuse within 6 months of screening
* With a history of illicit drug abuse within 6 months of screening
* Patients with increased intracranial pressure
* Having used other investigational drugs at the time of enrollment, or within 30 days.
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Study Objectives
Skin cancer risk is largely determined by sun exposure during childhood. This study determines the effectiveness of a mailed intervention designed to increase sun protection for children age 6-9 years old. The intervention includes newsletters for parents that include risk information tailored to each child. Also included are sun protection resources such as a swim shirt, a sun hat, and sunscreen. Participants receive the intervention over 3 consecutive years, and data collection includes telephone interviews and skin exams. The study hypothesis is that receipt of the intervention will result in improved sun protection of the child.
Intervention / Treatment
BEHAVIORAL: Semi-tailored newsletter
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Inclusion Criteria:
* Child born in 1998, has resided in the Denver, Colorado area
Exclusion Criteria:
* Parents unable to respond to telephone survey; child has disabling condition
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Study Objectives
The goal of this clinical research study is to learn if the study drug AZD2014 can shrink growing or symptomatic meningiomas.
Intervention / Treatment
DRUG: AZD2014
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Inclusion Criteria:
* Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF2 gene.
* Participants must have progressive or symptomatic meningioma. NOTE 1: Histologic confirmation of meningioma is not required in the setting of compatible radiographic appearance, NOTE2: progression is defined as an increase in target meningioma volume ≥ 20% OR ≥ 3 mm during the past 2 years.
-- Subjects must have a target meningioma that is not amenable to surgery due to patient preference or high risk for surgical complications
* Participants must be willing and able to undergo regular MRI scans of the brain
* Patients must have measurable disease, defined as at least one meningioma ≥ *0 ml that can be accurately measured by contrast-enhanced cranial MRI scan, performed within 28 days of study registration.
* Prior surgical resection and radiation therapy for the progressive meningioma are not required for study enrollment.
* Patients must have received less than 3 prior chemotherapy regimens for progressive meningioma.
* Patients receiving dexamethasone must be able to be treated with alternative corticosteroids such as prednisone, prednisolone, or methylprednisolone in the opinion of the treating physician.
* Patients must have available an archival paraffin tumor block sufficient to generate at least 20 unstained slides; or, if a paraffin tumor block is unavailable, at least 20 unstained slides.
* Age ≥ 18 years at the time of study enrollment.
* ECOG performance status ≤2 (Karnofsky ≥60%) with no deterioration over the previous 2 weeks
* Life expectancy of greater than 3 months
* Within 14 days of study registration, participants must have normal organ and marrow function as defined below:
* leukocytes ≥3,000/mcL
* absolute neutrophil count ≥1,500/mcL
* hemoglobin ≥90 g/L
* platelets ≥100,000/mcL
* total bilirubin ≤*5 x institutional upper limit of normal
* AST(SGOT)/ALT(SGPT) ≤*5 × institutional upper limit of normal
* Serum creatinine ≤*5 x institutional upper limit of normal concurrent with creatinine clearance ≥50 mL/min (measured or calculated by Cockcroft and Gault equation), confirmation of creatinine clearance is only required when creatinine is >*5xULN
* Urine protein ≤1+ on urine dipstick (if 2+ seen on first test, re-test at least 24 hours later)
* PT/INR/PTT (aPTT) <*5x institutional upper limit of normal
* The effects of AZD2014 on the developing human fetus are unknown. For this reason and because mTOR kinase inhibiting agents are known to be teratogenic, female patients must be willing to use 2 forms of highly effective contraception (per institution standards) from the time of screening until 4 weeks after discontinuing study, must not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child bearing potential or must have evidence of non-childbearing potential by fulfilling one of the following criteria at screening: * post-menopausal women, defined as either women aged more than 50 years and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments, or, * women under 50 years old who have been amenorrhoeic for at least 12 months following the cessation of exogenous hormonal treatments, and have serum follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels in the postmenopausal range for the institution. Alternatively, women must have documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
* Male patients should either be surgically sterile or willing to use an effective barrier method of contraception during the study and for 16 weeks following the last dose of study treatment if sexually active with a female of childbearing potential. If not done previously, storage of sperm prior to receiving AZD2014 will be advised to male patients with a desire to have children.
* Ability to understand and the willingness to sign a written informed consent document prior to any study specific procedures, sampling, and analyses.
* Ability to swallow and retain oral medication
Exclusion Criteria:
* Prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents within 21 days of starting study treatment (not including palliative radiotherapy at focal sites). Prior use of an investigational monoclonal antibody therapy within 3 months, or prior use of nitrosoureas or mitomycin C within 6 weeks. Patients must have recovered from acute toxicity due to radiotherapy.
* With the exception of alopecia, any unresolved toxicities from prior anti-tumor treatments (excluding corticosteroids) should be no greater than CTCAE (Version *0) Grade 1 at the time of study entry.
* Major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery (excluding tumor biopsies) within 14 days of first dose of study treatment
* Participation in another clinical study with an investigational product during the last 21 days.
* History of hypersensitivity to active or inactive excipients of AZD2014 or drugs with a similar chemical structure or class to AZD*
* Exposure to potent or moderate inhibitors or inducers of CYP3A4/5, Pgp (MDR1) and BCRP if taken within the stated washout periods before the first dose of study treatment (see Appendix B)
* Exposure to sensitive or narrow therapeutic range substrates of the drug metabolizing enzymes CYP2C8, CYP2C9, CYP2C19, CYP2D6 or the drug transporters Pgp (MDR1), BCRP, OATP1B1, OATP1B3, OCT1 and OCT2 within the appropriate wash-out period (a minimum of 5 x reported elimination half-life) before the first dose of study treatment (see Appendix B)
* Any haemopoietic growth factors (e.g., filgrastim \[granulocyte colony-stimulating factor; G-CSF\], sargramostim \[granulocyte-macrophage colony-stimulating factor; GM-CSF\]) within 14 days prior to receiving study treatment..
* Pre-treatment with other mTOR inhibitors may be allowed and should be discussed for each protocol and tumor type separately
* Current refractory nausea and vomiting, malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction.
* Previous meningioma progression during treatment with other mTORC1/2 inhibitors (but not mTORC1 inhibitors such as everolimus or other rapalogues)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, severe hepatic impairment, interstitial lung disease (bilateral, diffuse, parenchymal lung disease), uncontrolled chronic renal diseases (glomerulonephritis, nephrotic syndrome, Fanconi Syndrome or renal tubular acidosis), current unstable or uncompensated respiratory or cardiac conditions, uncontrolled hypertension, active bleeding diatheses, active hepatitis B or C infection, known active human immunodeficiency virus (HIV) infection, or psychiatric illness/social situations that would limit compliance with study requirements. Screening for chronic conditions is not required.
* History of other malignancies, except: Malignancy treated with curative intent and with no known active disease present for ≥5 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician, * adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease, * adequately treated carcinoma in situ without evidence of disease, or * Gleason 6 prostate cancer under observation.
* Patients who have experienced any of the following procedures or conditions currently or in the preceding 12 months:
* coronary artery bypass graft
* angioplasty
* vascular stent
* myocardial infarction
* angina pectoris
* congestive heart failure New York Heart Association Grade ≥2 ( ventricular arrhythmias requiring continuous therapy)
* supraventricular arrhythmias including atrial fibrillation, which are uncontrolled
* haemorrhagic or thrombotic stroke, including transient ischaemic attacks or any other central nervous system bleeding
* History of drug abuse or alcohol abuse, as judged by the Investigator
* Abnormal echocardiogram (ECHO) or multi-gated acquisition scan (MUGA) at baseline (left ventricular ejection fraction \[LVEF\] <55%. Appropriate correction to be used if a MUGA is performed.
* Pre-existing renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis
* Mean resting corrected QT interval (QTc), calculated using Fridericia's formula, > 470 msec obtained from 3 electrocardiograms (ECGs), family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation or Torsade de Pointes within 12 months of the patient entering in the study
* Patients with Diabetes Type I or uncontrolled Type II (HbA1c >8% assessed locally) as judged by the Investigator or Abnormal fasting glucose value defined as >126 mg/dL (>7 mmol/L).
* Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation or risk of arrhythmic events (such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years-of-age).
* Vaccinated with live, attenuated vaccines within 4 weeks of the first dose of study drug.
* Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements. Note: patients who are likely to require surgery or radiation for NF2-related tumors during the first year of treatment in the investigator's opinion should not be enrolled on this clinical trial.
* Pregnant women are excluded from this study because AZD2014 is an mTORC1/2 inhibiting agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AZD2014, breastfeeding should be discontinued if the mother is treated with AZD*
* HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AZD* In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy.
* Involvement in the planning and/or conduct of the study (applies to both AstraZeneca, CRO staff, and/or staff at the CPU)
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Study Objectives
This study is being performed so that tumor and blood samples from patients who will receive breast cancer treatment prior to surgery can be collected and stored for future research.
Intervention / Treatment
PROCEDURE: tissue procurement
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Inclusion Criteria:
* All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0 or M1). Recurrent disease in the breast is also eligible.
* The patient's clinical plan will include neoadjuvant systemic therapy (chemotherapy, hormonal therapy, biologic therapy), prior to surgery on the breast.
* The clinical plan for patients with recurrent or M1 disease must include breast surgery after neoadjuvant systemic therapy. This would include patients with non-bulky M1 disease who the treating physicians feel would benefit from local control of disease after neoadjuvant systemic therapy.
* Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
* All patients are required to sign an informed consent regarding the experimental purpose of the research biopsies and serum banking, in accordance with the University of Michigan Institutional Review Board standards.
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Exclusion Criteria:
* Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound.
* Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound.
* Patients must not have received any prior chemotherapy, hormonal therapy, or radiation therapy for their current breast cancer. Patients who received tamoxifen or other agents for prevention of breast cancer may be included.
* Patients with another active systemic malignancy in the past year.
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Study Objectives
This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients with prior adjuvant chemotherapy were allowed to enroll on this trial.
Intervention / Treatment
DRUG: docetaxel (Taxotere®), DRUG: ZD1839
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Inclusion Criteria:
* Patients must be greater than or equal to 70 years of age.
* Patients must have histologically confirmed non-small cell lung cancer (NSCLC) that is Stage IIIb (with pleural effusions) or Stage IV.
* Patients must be previously untreated for metastatic disease but may have received previous adjuvant chemotherapy more than six months prior to registration. Patients may also have received radiation therapy for advanced disease; however there should be measurable disease outside the radiation ports.
* Disease must be at least unidimensionally measurable. Lesions, which are located within a previously irradiated field, are not considered measurable unless there is a documented growth in its size.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or *
* Laboratory values must be as follows: White blood cell count greater than or equal to 3,000/mm\^3; Absolute neutrophil count greater than or equal to 1,500/mm\^3; Platelets greater than or equal to 100,000/mm\^3; Total bilirubin less than or equal to *0 x institutional upper normal limit; Serum creatinine less than or equal to 2 x institutional upper normal limit; aspartic transaminase (AST) or ALANINE TRANSAMINASE (ALT) less than or equal to *5 x institutional upper normal limit; Alkaline Phosphatase less than or equal to *5 x institutional upper normal limit; Serum calcium less than or equal to *5 x institutional upper normal limit (corrected for serum albumin).
* Patients with combined alkaline phosphatase, AST and/or ALT elevations will not be allowed to enroll on protocol.
* Patients must have recovered from all acute toxicities from previous therapy, excluding alopecia.
* In keeping with the policies of the institution, patients must sign an informed consent form indicating that they are aware of the investigational nature of this study
* Patients with stable brain metastases after completion of radiation will be allowed to enroll in this trial.
* Patients treated with adjuvant therapy more than six months ago will be allowed to enroll in this trial.
* Cognitively impaired patients will be allowed to enroll on the trial if the legal guardian signs the consent form after a full informed consent process is completed. Whenever feasible the cognitively impaired person will also give assent to participation in the trial.
Exclusion Criteria:
* Patients previously treated with chemotherapy or ZD*
* Patients with known or clinical evidence of active central nervous system (CNS) metastasis. Patients with stable, previously treated brain metastases will be allowed.
* Male Patients with female sexual partners in the reproductive age group who refuse to use effective methods of contraception will be excluded from the trial.
* Patients with concurrent serious infections (i.e., receiving an intravenous antibiotic) are not eligible.
* Patients with an unstable or serious concurrent medical condition are excluded. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, grade 3 neuropathies, spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
* Patients receiving other non-approved or investigational therapy concurrently or within 30 days of Day 1 of trial treatment.
* Patients with a history of other cancers except basal cell skin cancers, carcinoma of the cervix in situ, or curatively-treated cancers with > 2 years non-recurrence prior to entry in the trial. Patients with a history of other cancers must have histological confirmation that current disease is compatible with diagnosis of NSCLC.
* Peripheral neuropathy >* (Peripheral neuropathy must be < grade 1)
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Docetaxel, ZD 1839, Polysorbate 80, or other agents used in the study.
* Patients with combined alkaline phosphatase, AST and/or ALT elevations will be excluded from this protocol.
* Patients previously treated with radiation therapy.
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Study Objectives
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies. This study will also learn more about how the combination of these two investigational drugs may work for patients with certain cancers (specifically metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic colorectal cancer and recurrent glioblastoma multiforme).
Intervention / Treatment
DRUG: LDE225, DRUG: BKM120
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Inclusion Criteria:
* Male or female adult patients (> 18 years)
* Patients with histologically/cytologically confirmed diagnosis of the following advanced tumors that have progressed despite standard therapy or that have no available established treatments: metastatic breast cancer, pancreatic adenocarcinoma, metastatic CRC or recurrent GBM will be included.
* Provision of an archival tumor sample to a Novartis designated laboratory for molecular profiling. The tumor material submitted for these analyses may have been obtained at any time during the course of the patient's disease.
* Measurable disease as assessed by RECIST *1 for non-GBM tumors and by RANO criteria for GBM.
* ECOG (WHO) performance status 0-2
* Adequate bone marrow and organ function
* Patient is able to swallow and retain oral medication
* Negative serum pregnancy test; non-lactating or post-menopausal women.
Exclusion Criteria:
*Use of other investigational drugs within 30 days of enrollment or 5 half-lives of enrollment, whichever is longer. *History of hypersensitivity to LDE225, BKM120 or to drugs of similar chemical classes.
*Patient has received previous treatment with PI3K inhibitors and/or smoothened inhibitors.
*Patients with recurrent GBM who have received radiotherapy within 3 months of initiating study treatment.
*Patients with primary CNS tumor (except recurrent GBM), uncontrolled or symptomatic CNS metastasis. However, patients with controlled, asymptomatic or with resected CNS metastases with no radiological evidence of disease or with stable brain metastasis with no progression may be are eligible.
*Patients who have neuromuscular disorders or are on concomitant treatment with drugs that are recognized to cause rhabdomyolysis, such as HMG CoA inhibitors (statins), clofibrate and gemfibrozil. If it is essential that the patient remains on a statin to control hyperlipidemia, only Pravastatin may be used with extra caution.
*Patients who require the use of warfarin (substrate of CYP2C9) cannot be enrolled as LDE225 and BKM120 are competitive inhibitors of CYP2C9 based on in-vitro data.
*Patient is currently being treated with drugs known to be strong inhibitors or inducers of CYP3A4/5, which cannot be discontinued or switched to a different medication 7 days prior to starting study treatment and for the duration of the study.
*Patient has a score ≥12 on the PHQ-9 questionnaire. A normal evaluation by a psychiatrist or psychologist can overrule this exclusion).
*Patients who select responses of "1", "2" or "3" to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9), (a normal evaluation by a psychiatrist or psychologist can overrule this exclusion).
*Patient has a GAD-7 mood scale score ≥ 15, (a normal evaluation by a psychiatrist or psychologist can overrule this exclusion) *Patient has a documented medical history of or active major depression episode, bipolar disorder (I or II), obsessive compulsive disorder, schizophrenia, a history of suicidal attempts or ideation, or homicidal ideation (e.g. risk of doing harm to self or others) * Patient has ≥CTCAE grade 3 anxiety *Current medical history of the following:
* Use of a pacemaker
* History of or presence of clinically significant ventricular or atrial tachyarrhythmia
* Clinically significant resting bradycardia (< 45 beats per minute)
* History of clinically documented myocardial infarction
* History of unstable angina pectoris
* History of known structural abnormalities (i.e. cardiomyopathy) *Clinically significant cardio-vascular disease *Clinically significant abnormal ECG *Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO) *Patient is currently receiving treatment with QT prolonging medication known to have a risk to induce Torsades de Pointes, and the treatment cannot be discontinued or switched to a different medication 7 days prior to starting the study and for the duration of the study *Patients who are not willing to apply highly effective contraception as defined by the protocol during the study and through the duration of the study. Note: Hormonal contraception methods (e.g. oral, injected, implanted) are not allowed as it cannot be ruled out that the study drug decreases the effectiveness of hormonal contraception *Sexually active males who are unwilling to use a condom during intercourse while taking drug and for 6 months after stopping investigational medications and agree not father a child in this period.
*Patients is currently receiving increasing or chronic treatment with corticosteroids ((≥ the anti-inflammatory potency of 4mg dexamethasone) or another immunosuppressive agent.
*Patient has been treated with any hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF) ≤ 2 weeks prior to starting study drug. Erythropoietin or darbepoetin therapy, if initiated before enrollment, may be continued *Patient who has received chemotherapy, targeted therapy or immunotherapy ≤ 3 weeks (6 weeks for nitrosourea, mitomycin-C or monoclonal antibodies; 1 week for hormonal anti-cancer therapy) prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia, bone marrow and organ functions) *Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of LDE225 and BKM120 (e.g., ulcerative colitis, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection) *Patient has a known history of HIV infection (testing not mandatory)
AMENDMENT 1 CHANGES:
Inclusion Criteria:
* Provision of an archival tumor sample to a Novartis designated laboratory for molecular profiling. It is accepted that it may not be possible to obtain all samples prior to commencing study treatment. It is also accepted that it may not be possible to obtain a sample (e.g. if sufficient sample does not exist), and in this situation inclusion of the patient should be discussed with Novartis (as this may not make a patient ineligible).
Exclusion Criteria:
* Patients with primary CNS tumor (except recurrent GBM), uncontrolled or symptomatic CNS metastasis. However, patients with controlled, asymptomatic or with resected CNS metastases with no radiological evidence of disease or with stable brain metastasis with no progression may be eligible. The patient must have completed any prior treatment for CNS metastases (including radiotherapy and/or surgery) ≥ 28 days (> 14 days for stereotactic radiosurgery).
* Patient has a score ≥12 on the PHQ-9 questionnaire. A normal evaluation by a psychiatrist can overrule this exclusion.
*Patients who select responses of "1", "2" or "3" to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9), (a normal evaluation by a psychiatrist can overrule this exclusion).
*Patient has a GAD-7 mood scale score ≥ 15, (a normal evaluation by a psychiatrist can overrule this exclusion)
AMENDMENT 2 CHANGES:
Updated Inclusion Criteria:
* Revised to specify the groups of patients that will be included in the dose escalation and dose expansion parts (NEW tumor type added here): Patients with histologically/cytologically confirmed diagnosis of the following advanced tumors that have progressed despite standard therapy or that have no available established treatments: four group of patients during the dose escalation part: metastatic breast cancer, advanced pancreatic adenocarcinoma, metastatic CRC or recurrent GBM and five groups during the dose expansion part: triple negative metastatic breast cancer, hormone receptor positive (ER+/PR+, and Her2-) metastatic breast cancer, recurrent GBM, GASTRIC/GASTROESOPHAGEAL JUNCTION CANCER, advanced pancreatic adenocarcinoma or metastatic CRC will be included.
* ECOG (WHO) performance status 0-* ADDED "only applies to patients enrolled under the original and Amendment 1 protocol versions." * Two sub-bullets updated: Potassium, and calcium, within normal limits for the institution. Out of range values should be clinically insignificant. Serum Creatinine ≤ *5 x ULN and 24-hour creatinine clearance ≥ 50 mL/min (determined by inputting the serum creatinine result into the Cockcroft-Gault formula).
* NEW Inclusion criterion: Recurrent GBM patient has a Karnofsky performance status (KPS) score ≥ *
* NEW Inclusion criterion:ECOG (WHO) performance status 0-1 (only applies to patients enrolled under Amendment 2 and any later protocol versions).
Updated Exclusion Criteria:
* Patient has a score ≥12 on the PHQ-9 questionnaire. REMOVED "A normal evaluation by a psychiatrist can overrule this exclusion." *Patients who select responses of "1", "2" or "3" to question number 9 on the PHQ-9 questionnaire regarding potential for suicidal thoughts or ideation (independent of the total score of the PHQ-9). REMOVED "A normal evaluation by a psychiatrist can overrule this exclusion." * Patient has a GAD-7 mood scale score ≥ * REMOVED "A normal evaluation by a psychiatrist can overrule this exclusion." * Patient has a documented medical history of or active major depression episode, bipolar disorder (I or II), obsessive compulsive disorder, schizophrenia, a history of suicidal attempts or ideation. ADDED "or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to DSM- IV, Diagnostic and Statistical Manual of Mental Disorders, 4th edition) are not eligible. Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug." * REMOVED mention of "Double barrier method" term under "Male patient" section * Patient who has received chemotherapy, targeted therapy or immunotherapy ≤ 3 weeks (6 weeks for nitrosourea, or mitomycin-C; or 6 weeks for monoclonal antibodies if carryover effects are suspected; 1 week for hormonal anti-cancer therapy) prior to starting study drug or who have not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia, bone marrow and organ functions). ADDED clarification concerning the washout period for monoclonal antibodies.
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Study Objectives
Investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African American female breast or endometrial cancer survivors diagnosed with type 2 diabetes.
Intervention / Treatment
BEHAVIORAL: Standard Behavioral Weight Change Intervention
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Inclusion Criteria:
* African American women, ages 30
* No evidence of pregnancy, as evidenced by negative urine pregnancy test.
* Diagnosed with type 2 diabetes by their provider
* Diagnosed with Stage I-III breast or endometrial cancer
* Completed treatment for breast or endometrial cancer at least 4 months and no more 5 years ago English-speaking
* Agree to participate in all aspects of the semi-structured interview (Aim 1)
* Agree to participate in all aspects of the feasibility study, including group sessions (Aim 2)
* Access to the internet via phone or computer
* Access to a working phone for personal use
Exclusion Criteria:
* Non-English speaking
* Recent epilepsy, cardiac event or stroke in last 6 months,special nutritional needs (e.g. current evidence of malignancy; HIV)
* History of epilepsy, cardiac event or stroke within the last year
* Known diagnosis of HIV
* Known new malignancy
* Less than 4 months or more than 2 years post treatment of Stage I-III breast or endometrial cancer.
* No diagnosis of type 2 diabetes
* No self-report of African American race/ethnicity
* No access to a phone for personal use
* No access to the internet via computer or mobile phone
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Study Objectives
Toll-like receptors (TLRs) play a key role in the innate immune system. Toll-like receptor-4 (TLR4) in particular, appears to play a role in susceptibility to cancer. Of 44 identified SNPs (small nucleotide polymorphisms) in TLR4, the most common is an A-G substitution at nucleotide position +896, downstream of the cDNA start codon, a missense mutation which leads to an amino acid substitution Asp299Gly in the third exon of the TLR4 gene. Pre-clinical studies from our laboratory have shown an association of TLR4 with ultraviolet radiation induced skin cancer. Hence, in this study we will assess the pattern of TLR4 polymorphisms and susceptibility to skin cancer.
Intervention / Treatment
DIAGNOSTIC_TEST: Detection of single nucleotide polymorphisms (SNP)
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Inclusion Criteria:
* Male or female over the age of 50
* Fitzpatrick skin type I-IV
Exclusion Criteria:
* Tumor types other than basal cell carcinoma, squamous cell carcinoma and melanoma
* Chronic immunosuppression due to transplant antirejection regimen or HIV/AIDS
* Nevoid basal cell carcinoma syndrome, Cowden's syndrome, xeroderma pigmentosum or other syndrome with skin-cancer predisposition
* Known exposure to arsenic or ionizing radiation
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Study Objectives
This is a research study for pancreatic cancer. One way of improving the results of current standard treatments is to try new approaches. This study will examine the use of a more advanced radiation therapy technique, called intensity modulated radiation therapy (IMRT), with chemotherapy. All subjects on this study will be treated with gemcitabine. This chemotherapy agent has been used for patients with pancreatic cancer. The researchers have already done studies using radiation therapy and gemcitabine. They want to build on the information they have from this previous research. The researchers want to find the best dose of IMRT that can be given at the same time that patients are receiving gemcitabine. To do this, they will vary the total dose of radiation received by patients on this study based on the information they have available from previously treated patients. The goal of the research is to identify the highest dose of IMRT that can be given at the same time as the chemotherapy without causing severe side effects.
Intervention / Treatment
RADIATION: INTENSITY MODULATED RADIOTHERAPY, DRUG: Gemcitabine
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Inclusion Criteria:
* Is the patient 18 years of age or older.
* Does the patient have histologically or cytologically proven carcinoma of the pancreas
* Is the tumor unresectable or medically inoperable
* Does the patient have a Zubrod performance status of ≤ 2 (appendix I).
* Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥ 100,000/mm3
* Does the patient have adequate renal function (creatinine < 2 mg/dl) and hepatic function (bilirubin < 3 mg/dl), with relief of biliary obstruction if present
* Is the patient free of significant co-morbid conditions that would preclude safe administration or completion of protocol therapy
* If the patient is of reproductive potential, has he or she agreed to use an effective method of contraception during treatment on this trial and for 6 months after treatment
* Is the patient aware of the investigational nature of the therapy such that they can provide written informed consent
Exclusion Criteria:
* Does the patient have a neuroendocrine tumor of the pancreas
* Does the patient have metastatic disease
* Does the patient have a history of abdominal radiation therapy
* Is there history of more than 1 month of therapy with single agent gemcitabine
* Has the patient used any investigational agent in the month before enrollment into the study
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Study Objectives
Colonoscopy is the gold-standard for the evaluation of the colorectal mucosa. Colonoscopy quality indicators are the adenoma detection rate, the rate of cecal intubation and the bowel preparation.
The role of diet in preparing for colonoscopy is not fully established. Currently there is not enough evidence available to choice between 3 days of low residue diet versus 1 day.
The research hypothesis is that the low residue diet offers a non-inferior bowel preparation and an improved tolerance.
Intervention / Treatment
OTHER: 1 day low residue diet, OTHER: 3 day low residue diet
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Inclusion Criteria:
* Participants in the colorectal cancer screening program that give consent
Exclusion Criteria:
* Contraindication for colonoscopy
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Study Objectives
Indications for post-hysterectomy radiation therapy (RT) have been well established by clinical data. Adjuvant RT has demonstrated local control and survival benefit. In patients with nodal disease, adjuvant chemotherapy concurrent with radiation has further improved the clinical outcome. The acute hematological and gastrointestinal toxicity of concurrent chemo-radiotherapy can be quite high, sometimes preventing patients from completed their full treatment course, potentially compromising the therapeutic benefit of treatment. Intensity modulated radiation therapy (IMRT) is an advanced method of delivering external beam radiation that may minimize the volume of normal tissue irradiated to high dose and thus decrease the risk of normal tissue toxicity. Helical tomotherapy is a novel treatment device with sophisticated imaging and treatment delivery features that are optimally suited for IMRT. There are retrospective clinical data supporting the use of non-tomotherapy delivered IMRT to treat patients with gynecologic cancers. The proposed study will prospectively test whether helical tomotherapy is a feasible method for delivering IMRT in post-hysterectomy cervical cancer patients receiving adjuvant RT. Here, the question of feasibility is simply one of verifying that target volumes are reliably covered by 'sculpted' IMRT high-dose regions. Although this is not a treatment effectiveness study, we will also follow the clinical outcome of these patients, including toxicity, local control and survival, in anticipation that this information will be valuable if the treatment modality is judged feasible and will be used for further treatments of this patient population.
Intervention / Treatment
RADIATION: IMRT with tomotherapy
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Inclusion Criteria:
* Age >= 18
* Karnofsky Performance Status of >= 60
* FIGO Stage I -IIB
* Pathologic confirmation of cervical cancer
* Status post hysterectomy
* Patients with local or regional metastases are eligible for this protocol, but not those with distant metastases
Exclusion Criteria:
* Age < 18
* Karnofsky Performance Status < 60
* Radiographic or pathologic evidence of distant metastatic disease
* Prior pelvic radiation therapy, other than trans-vaginal ring brachytherapy irradiation for acute hemostasis
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Study Objectives
STUDY QUESTION: Which of the four abnormally elevated androgen groups (total testosterone \[TT\], androstenedione \[A4\], free androgen index \[FAI\], or dehydroepiandrosterone-sulfate \[DHEA-S\]) present with an unfavorable metabolic and hormonal profile, appear to be more insulin-resistant and pose additional cardiovascular risk? SUMMARY ANSWER: Subjects with excess free androgen index tend to be obese and face the highest metabolic syndrome risk, adipocytokine alterations, insulin resistance (IR) and cardiovascular risk. The excess TT group presents with a marginal IR risk, while the excess A4 group has the highest antimüllerian hormone (AMH), and may counterbalance obesity; this group and the excess DHEA-S group have a favorable association with IR.
Intervention / Treatment
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Inclusion Criteria:
* Hyperandrogenic women who were classified into four groups:
* Total testosterone (TT),
* Androstenedione (A4),
* Free androgen index (FAI),
* and Dehydroepiandrosterone sulphate(DHEA-S).
* According to abnormally elevated androgen measures each above its cut-off value, and non hyperandrogenic women (who had all androgens below their cut-off values)
Exclusion Criteria:
* None of the women studied had
* Hypogonadotropic hypogondism,
* Hyperprolactinemia,
* Congenital adrenal hyperplasia,
* Premature ovarian failure,
* Androgen-secreting tumors,
* Cushing's syndrome,
* or any other endocrine or systemic disease that may affect the reproductive function,
* or any disorders of the uterus (e.g. Asherman's syndrome and Mullerian genesis) and chromosomal anomalies (e.g. Turner's syndrome).
* In addition, we excluded females who had
* Experienced menarche less than three years preceding the study start,
* or who had day 3 FSH > 15 mIU/ml, as well as women with insufficient clinical/biochemical records,
* and women with ovarian cysts or tumors in an ultrasonographic examination.
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Study Objectives
Clinical trials are critical to informing the care of patients with cancer. However, only 3-5% of patients with cancer enroll in clinical trials. Poor accrual to trials has major implications with regards to the pace of progress, the cost of clinical cancer research, and the generalizability of results. The investigators have recently shown in an analysis of 7,776 cancer clinical trials registered on clinicaltrials.gov that approximately 20% of cancer clinical trials fail to complete enrollment at all; the most often cited reason was poor accrual.
Prior research has identified barriers to cancer clinical trial accrual that can be generally categorized in the domains of availability, awareness, and acceptance. Much attention has been paid to the barriers involvement awareness and acceptance - however, trial availability is likely a "rate limiting step". This pilot study is the first in a series of planned steps to attempt to shift the current paradigm of "bringing patients to trials" to "bringing trials to patients." With the integration of telemedicine visits, the investigators aim to decrease the burden of participation for patients, begin to address geographic barriers, and ultimately improve trial accrual. In this study, men with biochemically recurrent prostate cancer (a rising PSA after definitive local therapy) will receive the antidiabetic drug, metformin. Patients will require a single on-site visit for study enrollment. The remainder of the 6 month study will be conducted via a HIPPA secure telemonitoring system (monthly visits conducted via telemedicine with tablet computers provided to each patients).
Intervention / Treatment
DRUG: Metformin
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Inclusion Criteria:
* Histologically confirmed adenocarcinoma of the prostate. (\*in situations where pathology reports documenting prostate cancer are no longer available such as when the initial biopsy or prostatectomy was performed in the remote past, a documented history of prior prostate cancer and prostate cancer treatment in prior medical records will be sufficient)
* Biochemical disease progression after radical prostatectomy and/or radiation therapy (external-beam radiation therapy and/or brachytherapy), and no radiographic evidence of metastases.
* Men with history of radical prostatectomy are required to have baseline PSA > *5 ng/mL (Prior treatment with neoadjuvant, adjuvant, or salvage radiation therapy is allowed, again, with screening PSA greater than or equal to *5 ng/mL required for eligibility).
* Men treated with primary radiation therapy are required to have baseline PSA ≥ *0 ng/mL above their post radiation nadir for men who were treated with primary radiation therapy (external beam and/or brachytherapy). Men who had primary radiation therapy followed by salvage prostatectomy are eligible if screening PSA is greater than or equal to *5 ng/mL.
* Men with previous neoadjuvant adjuvant hormone therapy are eligible if testosterone level at screening is non-castrate (≥ 50 ng/dl). Men previously treated with intermittent hormonal therapy are also eligible if level of testosterone at screening is non-castrate (≥ 50 ng/dl).
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 (Karnofsky greater than or equal to 60%).
* Subjects must have normal organ as defined below:
* AST(SGOT)/ALT(SGPT) less than or equal to *8 X institutional upper limit of normal
* Serum bilirubin ≤ ULN (except for subjects with Gilbert's Disease who are eligible despite elevated serum bilirubin level)
* Creatinine ≤ *5 mg/dL and/or creatinine clearance > 60 ml/min
* English speaking
Exclusion Criteria:
* Concurrent use of other investigational agents or other prostate cancer therapies (e.g., androgen deprivation therapy)
* Currently taking metformin, sulfonylureas, thiazolidinedione, insulin, or other antidiabetic drugs for any reason.
* Known hypersensitivity or intolerance to metformin
* Condition associated with increased risk of metformin-associated lactic acidosis:
* New York Heart Association Class III or IV Heart Failure
* Intake of 3 or more alcoholic beverages per day
* Known history of lactic acidosis
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Study Objectives
This phase II trial studies how well Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride in treating patients with stage I-IIIA non-small cell lung cancer that can be removed by surgery. Monoclonal antibodies, such as Nivolumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as Cisplatin and Pemetrexed Disodium or Gemcitabine Hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Nivolumab, Cisplatin, and Pemetrexed Disodium or Gemcitabine Hydrochloride may work better in treating patients with non-small cell lung cancer.
Intervention / Treatment
BIOLOGICAL: Nivolumab, DRUG: Cisplatin, DRUG: Pemetrexed Disodium, DRUG: Gemcitabine Hydrochloride
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Inclusion Criteria:
* Pathologically confirmed non small cell lung cancer (NSCLC), not previously treated, with a plan to undergo surgery
* Stage I-IIIA (stage I tumors must be >= 4 cm) per AJCC 8th edition
* Tumor sample must be available for PD-L1 testing; archival tissue within 3 months of study enrollment will be used; if archival tissue is unavailable, a fresh biopsy will be taken
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* While blood cells 2000/ul or more
* Absolute neutrophil count 1500/ul or more
* Platelets 100,000/ul or more
* Hemoglobin 9 g/dl or more; (transfusion permitted)
* Bilirubin less than or equal to *5 x the upper limit of normal (except subjects with Gilbert syndrome, who can have total bilirubin < 3 mg/dl)
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 x the upper limit of normal
* Glomerular filtration rate (GFR) greater than or equal to 40 ml/min using the Cockcroft-Gault formula or serum creatinine less than or equal to *5 x (ULN) upper limit of normal
* Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \[HCG\]) within 21 days of the study enrollment
* Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 23 weeks after the last dose of study drugs; "women of reproductive potential" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level more than 40 mIU/mL
* Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 31 weeks after the last dose of study drugs; men who are azoospermic do not require contraception
* All subjects must be able to comprehend and sign a written informed consent document
Exclusion Criteria:
* Patients who have participated in a study with an investigational agent or device within 2 weeks of enrollment
* Any prior radiotherapy to the lung
* Any prior treatment for NSCLC
* Epidermal growth factor receptor (EGFR) or alkaline phosphatase (ALK) activating alteration
* Any prior therapy with anti-PD-1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
* Any history of a sever hypersensitivity reaction to any monoclonal antibody
* Any history of allergy to the study drug components
* Any concurrent malignancies- exceptions include- basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer or in situ cervical cancer that has undergone potentially curative therapy; patients with a history of other prior malignancy must have been treated with curative intent and must have remained disease-free for 3 years post-diagnosis
* Participants with an active autoimmune disease or any other condition requiring systemic treatment with either corticosteroids within 14 days (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
* Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.* Patients with evidence of interstitial lung disease or active, non-infectious pneumonitis. Patients with a history of interstitial lung disease or non-infectious pneumonitis requiring treatment with steroids are also excluded.
* Patients with a known human immunodeficiency virus infection (HIV 1/2 antibodies) or acquired immunodeficiency syndrome (HIV/AIDS), active hepatitis B (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C (e.g., hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] \[qualitative\] is detected)
* Patients who have received a live vaccine within 30 days prior initiation of the systemic regimen
* Patients must not be receiving any other investigational agents
* Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial
* Women must not be pregnant (as above) or breastfeeding
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Study Objectives
By doing this study, researchers hope to learn the following:
* If providing hyperbaric oxygen (HBO) therapy prior to an umbilical cord blood (UBC) transplant will help to improve the homing process
* The safety of HBO administration in the setting of the UBC transplant
* The effects of HBO therapy on the engraftment process
Intervention / Treatment
DEVICE: Administration of hyperbaric oxygen
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Inclusion Criteria:
* Voluntary written informed consent
* Subjects must be >/= 17 yrs and </= 70 yrs for non-myeloablative transplant
* Subjects must be >/= 17 yrs and </= 55 yrs for myeloablative transplant
* Subjects with Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Myelodysplastic Syndrome (MDS), Hodgkin's Lymphoma (HL) and Non-Hodgkin's Lymphoma (NHL) who are considered for UCB transplant
* Use of approved form of contraception
* Karnofsky performance status of >/= 70%
* Adequate hepatic, renal, pulmonary and cardiac function. Criteria include:
* ALT (alanine aminotransferase), AST (aspartate aminotransferase: < 4x IULN (institutional upper limit of normal)
* Total bilirubin </= 2 mg/dL
* Serum creatinine < *0 mg/dL
* Left ventricular ejection fraction >/= 45%
* FEV1 (forced expiratory volume), FVC (forced vital capacity) and DLCD (diffusing capacity of lung for carbon monoxide) >/= 50% of predicted value (corrected to serum hemoglobin)
Exclusion Criteria:
* Pregnancy or breast feeding
* Severe chronic obstructive pulmonary disease requiring oxygen supplementation
* History of spontaneous pneumothorax
* History of seizures
* Claustrophobia
* Asthma
* Uncontrolled viral or bacterial infection at the time of enrollment
* Active or recent (prior 6 months) invasive fungal infection without interdisciplinary consult and approval
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Study Objectives
Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is less invasive and thereby has the potential to improve the postoperative course of right colonic cancer patients.
The objective of this study is to compare robotic right colectomy with either ICA or ECA in a randomized controlled setting.
Intervention / Treatment
PROCEDURE: Intracorporeal anastomosis, PROCEDURE: Extracorporeal anastomosis
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Inclusion Criteria:
All patients scheduled for robotic right colectomy due to colonic cancer are eligible for inclusion.
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Study Objectives
Objectives:
Colonoscopy and stool-based testing are the two predominant colorectal cancer (CRC) screening tests used in the US, and both reduce colorectal cancer mortality. However, only 62% of Americans are up to date with screening, partly because many individuals find these two tests inconvenient or unacceptable for a variety of reasons. There is an unmet need for a non-invasive test that does not require bowel preparation or handling stool, and the Septin9 DNA blood test may be an alternative for those individuals who would otherwise remain unscreened.
Aims:
Aim 1: To measure screening uptake with a blood test in screen-resistant patients who have declined both colonoscopy and fecal immunochemical testing (FIT) at the Manhattan VA Medical Center
* Sub-Aim 1a: To assess the proportion of those with a positive blood-based screening test who undergo diagnostic colonoscopy
* Sub-Aim 1b: To describe the endoscopic findings on diagnostic colonoscopy
Aim 2: To survey screen-resistant patients to understand their beliefs and attitudes about colorectal cancer screening and testing options
We hypothesize that a substantial proportion of patients who have refused colonoscopy and FIT will accept the blood test. We hypothesize this will be driven by the convenience of the blood test.
Methods:
This will be randomized controlled trial of individuals who have refused colonoscopy and FIT within past 6 months. Eligible patients will be randomized 1:1 to the intervention or control group. Both groups will be invited to participate in navigated colonoscopy or FIT by letter and telephone call. The intervention group will also be invited to participate in the blood test if they refuse colonoscopy and FIT. We will enroll 180 participants in each group (total n=360).
Intervention / Treatment
DIAGNOSTIC_TEST: Septin9
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Inclusion Criteria:
* not up-to-date with colorectal cancer screening, defined as a colonoscopy in the past 10 years, a stool test (FOBT/FIT) in the past year, or a flexible sigmoidoscopy in the past 5 years.
* Declined colorectal cancer screening (both colonoscopy and FIT) in the previous 6 months, which must be documented in the electronic health record
Exclusion Criteria:
* Personal history of colonic adenomas (including sessile serrated adenomas), proximal hyperplastic polyps, CRC, inflammatory bowel disease, or hereditary gastrointestinal cancer syndrome
* First degree relative with CRC diagnosed at <60 years of age; family history of hereditary gastrointestinal cancer syndromes.
* Vulnerable populations
* Adult unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
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Study Objectives
Breast cancer is the most common cancer and cause of cancer- related deaths among women, accounting for 1.67 million (25.2%) new cases and 521,907 (14.7%) deaths worldwide. The prevalence and survival rates of breast cancer differ per country. In Indonesia, majority of patients (70.9%) go to the clinic with advanced stages of breast cancer. Five-year survival rate is 51.07%. One of the most important determinants of survival is education level and stage of breast cancer.
Current screening methods include mammography and radiology assessments, both of which have disadvantages specifically in Asian population. Mammography is less useful in Asian population because the population has denser breast, resulting to failure to diagnose cases of breast cancer in this population in 37-70% of cases. Moreover, screening methods provide binary answers, and therefore does not inform risk profile of the patients.
The investigators aim to implement PRS into the breast cancer screening process while observing the differences of genetic and non-genetic risk factor in patients with breast cancer and patients without any medical/family history of breast cancer in Indonesian population.
Intervention / Treatment
DIAGNOSTIC_TEST: Breast Cancer Risk Prediction Software
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Inclusion Criteria:
* For case group
* Had been diagnosed with primary breast cancer or tested positive for high penetrance genes (e.g. BRCA 1/2)
* Menarche age >12 years old
* Premenopausal
* For control group
* Premenopausal
* Menarche age >12 years old
* Asymptomatic
* Consented for the study and follow up
Exclusion Criteria:
* For case group:
First degree family history of breast or ovarian cancer
* For control group:
* Family history of breast or ovarian cancer
* First-degree relationship with the cases
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Study Objectives
This study aims to determine the performance of the Exact IBD-ACRN surveillance test to detect colorectal cancer (CRC) and colorectal neoplasia in patients with inflammatory bowel disease (IBD). Patients with an IBD diagnosis for at least eight years or diagnosis of primary sclerosing cholangitis (PSC) and who are eligible for CRC screening are eligible to participate in this study. Enrolled subjects will collect a stool sample for the Exact IBD-ACRN surveillance test. Subjects must have undergone colonoscopy no more than 90 days prior to enrollment and will undergo colonoscopy or surgical intervention within 120 days of enrollment. Tissue diagnosis of CRC will be established by histopathologic examination.
Intervention / Treatment
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Inclusion Criteria:
* Male or female 18-84 years of age, inclusive.
* Diagnosis of IBD or a diagnosis of PSC with IBD prior to enrollment date of this study.
* Must be a candidate for a surveillance colonoscopy, with the intention of CRC/dysplasia surveillance, or a candidate for surgical intervention based on prior histological confirmation of HGD or CRC.
* Written informed consent document signed and dated by the subject or legally acceptable representative.
Exclusion Criteria:
* Any condition that in the opinion of the investigator should preclude participation in the study.
* A history of aerodigestive tract cancer.
* Prior colorectal resection, except ileocolic resection in Crohn's disease patients.
* IBD limited only to the rectum and without a concurrent PSC diagnosis.
* Subject has participated in any clinical study within the previous 30 days wherein an investigational compound or device was, or may be, introduced into the subject.
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Study Objectives
To date, the scientific literature has yet to provide sufficient evidence regarding the pathophysiology of cording. The objective of this protocol is to evaluate the utility of non invasive vascular imaging for assessing the pathophysiology of cording in a small study cohort of patients who were treated for breast cancer. The hypothesis is that cording may have a vascular etiology
Intervention / Treatment
OTHER: Non invasive venous ultrasound
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Inclusion Criteria:
* Participants must be enrolled in Partners protocol # 2008P000540 "Prospective Analysis of Symptoms, Functionality and Quality of Life Questionnaires to Evaluate Lymphedema in Patients Following Treatment for Breast Cancer"
* Confirmed case of cording by a medical provider (Physician, Nurse Practitioner, Physician Assistant)
* Participants must be at least 18 years of age
* Life expectancy of greater than 1 year.
* Ability to understand and the willingness to sign a written informed consent document.
* Willingness to comply with required follow up Perometer measurements and clinical visits.
Exclusion Criteria:
* Participants who are not enrolled or have been removed from Partners Protocol # 2008P000540 will be excluded from this trial.
* Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
* History of prior surgery or radiation to the head, neck, upper limb, or trunk.
* Patients with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
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Study Objectives
A clinical trial examining the safety and effectiveness of ABX-EGF when given to patients with prostate cancer with or without tumor in other parts of the body.
Patients will be treated for a maximum of 48 doses (6 treatment courses; 8 doses per course) or until evidence of progressive disease.
Intervention / Treatment
DRUG: ABX-EGF
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Inclusion Criteria:
* Male 18 years of age or older
* Has tumor tissue available for diagnostics
* Failed front line luteinizing hormone-releasing hormone analogue (LHRH) such as leuprolide or goserelin, or failed orchiectomy, as evidenced by disease progression. Patients must continue on a LHRH analogue (unless the patient had an orchiectomy) throughout the course of the study
* ECOG score of 0 or 1
Exclusion Criteria:
* Any prior chemotherapy for prostate cancer besides hormonal therapy (including no prior EGFr targeting agent)
* Prior history of cancer other than prostate carcinoma within the past 5 years that has required treatment or been active (prior basal cell carcinoma is allowed)
* Known to be HIV positive
* Myocardial infarction within one year prior to entering the study
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