Expired Study
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Detroit, Michigan 48201


Purpose:

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.


Study summary:

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. PLEASE NOTE: THIS STUDY WAS INTENDED TO BE A PHASE I/II STUDY, BUT NEVER MOVED FORWARD TO PHASE II. (4-22-09)


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 or unstable disease for 3 months on hormonal therapy - Stable or unstable 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 - No uncontrolled hypertension (i.e., systolic blood pressure [BP] ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg) Pulmonary: - FEV1, DLCO, and FVC at least 50% 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 within the past 5 years except curatively treated squamous cell carcinoma in situ of the cervix, basal cell skin cancer, or any other curatively treated disease in complete remission 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


NCT ID:

NCT00027807


Primary Contact:

Study Chair
Lawrence G. Lum, MD, DSc
Barbara Ann Karmanos Cancer Institute


Backup Contact:

N/A


Location Contact:

Detroit, Michigan 48201
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 11, 2017

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