Breast Cancer Clinical Trial
Official title:
Phase I Study of Post Transplant rhIL-12 High Dose Cyclophosphamide, Thiotepa, and Carboplatin in the Treatment of Metastatic Breast Carcinoma
RATIONALE: Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by
stimulating a person's white blood cells to kill breast cancer cells.
PURPOSE: Phase I trial to study the effectiveness of interleukin-12 in treating women with
metastatic breast cancer who have received high-dose chemotherapy and peripheral stem cell
transplantation.
OBJECTIVES: I. Determine the toxic effect profile and maximum tolerated dose of
interleukin-12 (rhIL-12) in women with advanced breast cancer who have undergone high dose
chemotherapy with stem cell rescue. II. Determine the effect of rhIL-12 on cellular and
humoral immune systems following high dose chemotherapy. III. Explore the effect on
treatment failure of rhIL-12 after high dose chemotherapy with stem cell rescue.
OUTLINE: This is a dose escalation study of interleukin-12 (rhIL-12). RhIL-12 therapy begins
3-5 weeks after discharge from the chemotherapy/stem cell transplant hospitalization or 2-3
weeks after completion of posttransplant radiation. Patients receive rhIL-12 subcutaneously
twice a week for 12 consecutive weeks. Treatment continues in the absence of disease
progression or unacceptable toxicity. Cohorts of 3-6 patients are treated at each dose level
of rhIL-12. The maximum tolerated dose is defined as the dose at which no more than 1 of 6
patients experiences dose limiting toxicity. Patients are followed every 2 months after
treatment.
PROJECTED ACCRUAL: Approximately 6-35 patients will be accrued for this study within 1-2
years.
;
Primary Purpose: Treatment
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