Breast Cancer Clinical Trial
Official title:
INFUSION OF ACTIVATED T CELLS AND LOW DOSE INTERLEUKIN 2 COMBINED WITH PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR THE TREATMENT OF WOMEN WITH METASTATIC BREAST CANCER: PHASE I/II
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 T cells and interleukin-2 combined
with peripheral stem cell transplantation or bone marrow transplantation in treating women
who have stage IIIB or metastatic breast cancer.
OBJECTIVES: I. Evaluate the toxicities of the combination of low dose interleukin-2 (IL-2)
sargramostim (GM-CSF), and multiple doses of activated T cells (ATC) following peripheral
blood stem cell transplantation in women with stage IIIB or metastatic adenocarcinoma of the
breast. II. Evaluate the efficacy of this regimen in these patients.
OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously daily for 5 days prior to
peripheral blood stem cell (PBSC) collection or for 2 days prior to bone marrow harvest.
Following PBSC collection or bone marrow harvest, patients receive high dose chemotherapy
consisting of cyclophosphamide IV, carboplatin IV, and thiotepa IV over days -6 through -3.
Patients undergo PBSC transplantation on day 0. Following PBSC transplantation, patients
receive multiple doses of monoclonal antibody OKT3 activated T lymphocytes IV over 1 hour
between days 1 and 65, continuous low dose interleukin-2 (IL-2) IV over days 1-65, and
sargramostim (GM-CSF) subcutaneously on days 5-21. Patients are followed at day 100, as
clinically indicated, and then annually.
PROJECTED ACCRUAL: Approximately 40-60 patients will be accrued for this study within 1-2
years.
;
Primary Purpose: Treatment
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