Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
Stage IV Breast Cancer, Recurrent Breast Cancer

About this trial
This is an interventional treatment trial for Stage IV Breast Cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed advanced breast cancer that is refractory or unlikely to respond to hormonal therapy AND failed at least 1 prior chemotherapy regimen Symptomatic lymphangitic pulmonary dissemination allowed Extensive visceral metastasis allowed Patients who are refractory or who have failed to respond after at least 8 weeks of methotrexate or a methotrexate-containing regimen are not eligible Measurable disease No bone metastases Hormone receptor status: Estrogen receptor negative PATIENT CHARACTERISTICS: Age: Postmenopausal Sex: Female Menopausal status: Postmenopausal Performance status: Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 2.5 mg/dL SGOT no greater than 2 times normal Blood ammonia normal No hepatic failure Renal: BUN less than 60 mg/dL Creatinine no greater than 2.5 mg/dL Creatinine clearance greater than 60 mL/min No chronic renal failure Cardiovascular: No severe heart disease Pulmonary: No severe lung disease Other: No serious active infections or fever No other concurrent serious disease No prior or concurrent secondary malignancies within the past 2 years Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered No concurrent biologic therapy for metastatic breast cancer Chemotherapy: See Disease Characteristics At least 4 weeks since prior cytotoxic chemotherapy and recovered No other concurrent chemotherapy for metastatic breast cancer Endocrine therapy: See Disease Characteristics At least 4 weeks since prior hormonal therapy and recovered No concurrent hormonal therapy for metastatic breast cancer Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy for metastatic breast cancer Surgery: Not specified Other: At least 4 weeks since prior participation in experimental clinical trials No prior antineoplaston A10 therapy No other concurrent treatment for metastatic breast cancer No concurrent salicylates, nonsteroidal anti-inflammatory drugs, phenylbutazone, phenytoin, and sulfonamides
Sites / Locations
- Burzynski Clinic