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

NCT00003412 | Unknown Phase 1

• 3 other identifiers: CDR0000066424BIH-L97-0252NCI-T98-0002
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

recombinant interleukin-12 BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Interleukin-12 Subunit p35

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Interleukin-12; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• David Avigan, MD

  Beth Israel Deaconess Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: March 31, 2004
• Study Start: June 1, 1998
• Last Updated: September 17, 2013

Record last verified: 2001-10

Locations

US (1)