Phase I Study of Post Transplant rhIL-12 High Dose Cyclophosphamide, Thiotepa, and Carboplatin in the Treatment of Metastatic Breast Carcinoma
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.
Interventional
Primary Purpose: Treatment
David Avigan, MD
Study Chair
Beth Israel Deaconess Medical Center
United States: Federal Government
CDR0000066424
NCT00003412
June 1998
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |