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