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Biological Therapy in Treating Women With Stage IV Breast Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Biological Therapy in Treating Women With Stage IV Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Biological Therapy in Treating Women With Stage IV Breast Cancer Clinical research trials and Biological Therapy in Treating Women With Stage IV Breast Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Biological Therapy in Treating Women With Stage IV Breast Cancer. Biological Therapy in Treating Women With Stage IV Breast Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Biological Therapy in Treating Women With Stage IV Breast Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Biological Therapy in Treating Women With Stage IV Breast Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Biological Therapy in Treating Women With Stage IV Breast Cancer  Biological Therapy in Treating Women With Stage IV Breast Cancer
Biological Therapy in Treating Women With Stage IV Breast Cancer
For Condition: recurrent breast cancer,ductal breast carcinoma,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Roger Williams Medical Center ,
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase I/II trial to study the effectiveness of combining different biological therapies in treating women who have stage IV breast cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of armed activated T cells given in combination with interleukin-2 and sargramostim (GM-CSF) in women with stage IV breast cancer. - Determine the toxicity profile of this regimen in these patients. - Determine the clinical response and overall and progression-free survival of patients treated with this regimen. OUTLINE: This is a dose-escalation study of armed activated T cells. Patients undergo peripheral blood mononuclear cell (PBMC) collection. The PBMCs are treated ex vivo with monoclonal antibody OKT3 to form armed activated T cells (ATC). The armed ATC are expanded for 14 days in interleukin-2 (IL-2). Patients receive armed ATC IV over 30 minutes twice weekly for 4 weeks. Patients also receive IL-2 subcutaneously (SC) once daily and sargramostim (GM-CSF) SC twice weekly beginning 3 days before the first infusion of armed ATC and continuing until 7 days after the last infusion of armed ATC. Cohorts of 3-6 patients receive escalating doses of armed ATC until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are treated at that dose. Patients are followed at 1, 2, and 5 months and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for the phase I portion of this study and a total of 18-33 patients will be accrued for the phase II portion of this study within 4-6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: Phase I: - Histologically confirmed infiltrating ductal carcinoma of the breast - Metastatic disease - Clinically asymptomatic with non-life-threatening metastases allowed - Measurable or evaluable disease by radiograph, CT scan, MRI, nuclear medicine bone scan, or physical examination - No measurable disease allowed if tumor or metastasis has been removed or successfully treated prior to study - No rapidly progressive symptomatic disease affecting major organ systems (e.g., lungs and liver) - Stable disease for 3 months on hormonal therapy - Stable disease for at least 1 month after chemotherapy - No active brain metastases - Brain metastases previously treated with definitive radiotherapy and/or surgical resection allowed - Hormone receptor status: - Estrogen and progesterone receptor status known Phase II: - All Phase I criteria - HER2/neu overexpression (2+ or 3+) by immunohistochemistry - Prior trastuzumab (Herceptin) allowed if disease still overexpresses HER2/neu PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - Karnofsky 70-100% OR - ECOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 50,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic: - Bilirubin less than 1.5 times normal - SGOT less than 1.5 times normal Renal: - Creatinine no greater than 1.8 mg/dL - Creatinine clearance at least 60 mL/min - BUN no greater than 1.5 times normal Cardiovascular: - No myocardial infarction within the past year - No prior myocardial infarction with coronary symptoms requiring medication and/or depressed left ventricular function (LVEF less than 50% by MUGA) - No angina or coronary symptoms requiring medication and/or with depressed left ventricular function (LVEF less than 50% by MUGA) - No congestive heart failure requiring medical management - LVEF at least 50% at rest by MUGA Pulmonary: - FEV_1, DLCO, and FVC at least 60% predicted Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No other serious medical or psychiatric illness that would preclude study participation - No other prior or concurrent malignancy except curatively treated squamous cell carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - Prior trastuzumab allowed for phase I Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy Endocrine therapy: - See Disease Characteristics - Concurrent hormonal therapy for breast cancer must continue during study - No other concurrent hormonal therapy except steroids for adrenal failure, septic shock, or pulmonary toxicity or hormonal therapy for non-disease-related conditions (e.g., insulin for diabetes) Radiotherapy: - See Disease Characteristics Surgery: - See Disease Characteristics
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LawrenceLum, Study Chair, Roger Williams Medical Center
Roger Williams Medical Center *Recruiting*
Providence, Rhode Island, 02908-4735
United States
Recruiting Lawrence Lum 401-456-2672
Additional Information:
Study ID Numbers: CDR0000069072; RWMC-0335146
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027807
Other Recurrent Breast Cancer Studies:
1. Trastuzumab and Radiation Therapy in Treating Women With Stage III or Stage IV Invasive Primary Cancer of the Breast
2. Combination Chemotherapy in Treating Patients With Metastatic Breast Cancer
3. LY231514 Plus Gemcitabine in Treating Women With Metastatic Breast Cancer
4. Diagnostic Procedures in Women With Locally Advanced Breast Cancer Who Are Receiving Chemotherapy Before Breast Cancer Surgery
5. Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Rhode Island Clinical Trials
Other Providence Clinical Trials
Biological Therapy in Treating Women With Stage IV Breast Cancer
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