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Interleukin-12 in Treating Women With Metastatic Breast Cancer Who Have Received High-Dose Chemotherapy and Peripheral Stem Cell Transplantation



Interleukin-12 in Treating Women With Metastatic Breast Cancer Who Have Received High-Dose Chemotherapy and Peripheral Stem Cell Transplantation

For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Beth Israel Deaconess Medical Center
Synopsis: 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.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/60 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
DavidAvigan,  Study Chair,  Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center
Boston,  Massachusetts,  02215
United States
 


Additional Information:
Study ID Numbers:  CDR0000066424;  BIH-L97-0252,NCI-T98-0002
Study Start Date: June 1998
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003412

Other Recurrent Breast Cancer Studies:
1. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

2. Trastuzumab and Radiation Therapy in Treating Women With Stage III or Stage IV Invasive Primary Cancer of the Breast

3. Docetaxel and Epirubicin With and Without G-CSF in Treating Women With Metastatic Breast Cancer

4. Chemotherapy in Treating Patients With Breast Cancer

5. Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy

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Interleukin-12 in Treating Women With Metastatic Breast Cancer Who Have Received High-Dose Chemotherapy and Peripheral Stem Cell Transplantation
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