Vaccine Therapy and Interleukin-12 in Treating Women With Stage IV Breast Cancer

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Breast: Early Stage Disease
NCT ID: NCT00731406 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 03-221

 

RATIONALE: Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells. Interleukin-12 may stimulate the white blood cells to kill tumor cells. Giving vaccine therapy together with interleukin-12 may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-12 when given together with vaccine therapy and to see how well they work in treating women with stage IV breast cancer.

 

Conducting Institutions:
Beth-Israel Deaconess Medical Center, Dana-Farber Cancer Institute

Overall PI:
David Avigan, MD, Beth Israel Deaconess Medical Center

Site-responsible Investigators:

Contacts:
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Stage IV disease - Measurable disease by RECIST criteria - Accessible tumor, defined as a malignant effusion or one of the following disease sites measuring ≥ 2 cm: - Subcutaneous tissue - Superficial lymph nodes - Peripheral lung nodule accessible by video-assisted thoracic surgery - No clinical evidence of CNS disease - Hormone receptor status not specified PATIENT CHARACTERISTICS: - Menopausal status not specified - ECOG performance status 0-2 - Life expectancy > 6 weeks - WBC ≥ 2,000/mm³ - Bilirubin ≤ 2.0 mg/dL - Creatinine ≤ 2.0 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No clinically significant autoimmune disease - No concurrent serious illness, such as infection requiring IV antibiotics - No significant cardiac disease, including any of the following: - Arrhythmia - Ischemic coronary disease - Congestive heart failure - No history of clinically significant venous thromboembolic disease PRIOR CONCURRENT THERAPY: - No more than 2 prior chemotherapy regimens for metastatic disease - Following enrollment, patients may receive up to 2 courses/months of chemotherapy initiated at the time of vaccine generation - Any number of prior hormonal treatments allowed - More than 4 weeks since prior and no concurrent trastuzumab (Herceptin®) - More than 4 weeks since prior chemotherapy or hormonal therapy - More than 3 months since prior immunotherapy
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