Vaccine Therapy Plus Interleukin-2 in Treating Women With Stage IV, Recurrent, or Progressive Breast or Ovarian Cancer
Breast Cancer, Ovarian Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, recurrent ovarian epithelial cancer, stage IV ovarian epithelial cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast or ovary Stage IV, recurrent, or progressive disease with no chemotherapy or radiotherapy options available that would increase survival Tumor tissue available for determination of p53 protein expression and genetic mutation p53-positive tumor by immunohistochemical analysis HLA-A2.1 positive No prior CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0 or 1 Life expectancy: More than 3 months Hematopoietic: Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 4 times normal Hepatitis B surface antigen negative Hepatitis C antibody negative Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease No myocardial infarction within past 6 months No prior congestive heart failure No prior ventricular arrhythmias or other arrhythmias requiring therapy Immunologic: Must have positive intradermal delayed hypersensitivity test for 1 of the following: Mumps Trichophyton Tetanus Candida PPD No underlying immune deficiency No prior autoimmune disease including, but not limited to, the following: Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia Systemic lupus erythematosus, Sjögren's syndrome, or scleroderma Myasthenia gravis Goodpasture's syndrome Addison's disease Hashimoto's thyroiditis Active Graves' disease No active infection requiring antibiotics HIV negative Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other active malignancy within the past 2 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered At least 1 year since prior bone marrow transplantation Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: Prior anticancer hormonal therapy allowed At least 4 weeks since prior systemic steroids and recovered Radiotherapy: At least 4 weeks since prior radiotherapy and recovered Surgery: Not specified Other: Chronic suppressive antibiotics allowed
Sites / Locations
- NCI - Center for Cancer Research
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support