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Phase I Study of Post Transplant rhIL-12 High Dose Cyclophosphamide, Thiotepa, and Carboplatin in the Treatment of Metastatic Breast Carcinoma

Phase 1
18 Years
60 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

PROJECTED ACCRUAL: Approximately 6-35 patients will be accrued for this study within 1-2

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven stage IV breast cancer presenting as
primary metastatic disease or with recurrence after an initial diagnosis of localized
disease Enrollment in protocol for high dose chemotherapy with stem cell rescue using the
"STAMP V" regimen (cyclophosphamide, thiotepa, and carboplatin) No enrollment in research
transplant protocol whose primary endpoint is response duration or recovery time from
toxic effects No brain or CNS metastases Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 to 60 Sex: Female Menopausal status: Not specified
Performance status: Karnofsky 80-100% Life expectancy: At least 6 months Hematopoietic:
WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater
than 1.5 times normal SGOT no greater than 2.5 times normal Renal: Creatinine no greater
than 1.8 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: Systolic ejection
fraction at least 50% No significant cardiovascular disease or cardiac arrhythmia
requiring drug or device intervention Pulmonary: DLCO and FEV1 greater than 50%
Neurologic: No significant peripheral neuropathy or CNS disease Other: Fertile patients
must use effective contraception Not pregnant or lactating Not HIV positive No concurrent
active infections requiring IV antibiotic therapy No significant gastrointestinal bleeding
or uncontrolled peptic ulcer disease No history of inflammatory bowel disease No
clinically significant autoimmune disease No other serious illness or medical condition

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See
Disease Characteristics No concurrent chemotherapy Endocrine therapy: No concurrent
corticosteroids Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: At
least 4 weeks since any investigational drugs No concurrent investigational drugs

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David Avigan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Federal Government

Study ID:




Start Date:

June 1998

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215