Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Carcinoma of the Breast

Study start date: March 18, 1996

DISEASE CHARACTERISTICS: Histologically confirmed stage IV breast cancer that is unlikely to respond to existing therapy and for which no curative therapy exists Must have failed prior standard therapy Measurable disease by MRI or CT scan Tumor must be at least 2 cm in the lymph nodes in the head, neck, axillary, inguinal, or femoral areas and at least 0.5 cm in other locations Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal Status: Not specified Performance status: Karnofsky 60-100% Life expectancy: At least 2 months Hematopoietic: WBC at least 2,000/mm^3 Platelet count at least 50,000/mm^3 Hepatic: Bilirubin nor greater than 2.5 mg/dL SGOT/SGPT no greater than 5 times upper limit of normal No hepatic failure Renal: Creatinine no greater than 2.5 mg/dL No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: No chronic heart failure No uncontrolled hypertension No history of congestive heart failure No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: No severe lung disease, such as chronic obstructive pulmonary disease Other: Not pregnant or nursing Fertile patients must use effective contraception during and for 4 weeks after study participation No serious medical or psychiatric disorders No active infections No other serious concurrent disease PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy, except in patients with disease progression during or after initial therapy Recovery from prior immunotherapy No concurrent immunomodulating agents Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in patients with disease progression during or after initial therapy Recovery from prior chemotherapy No concurrent antineoplastic agents Endocrine therapy: At least 12 weeks since prior hormonal therapy, except in patients with disease progression during and after initial therapy Concurrent corticosteroids allowed Recovery from prior hormonal therapy Radiotherapy: At least 8 weeks since prior radiotherapy and recovered (patients with multiple tumors who have received radiotherapy to some, but not all, tumors may be admitted earlier than 8 weeks) Surgery: Recovered from any prior surgery Other: No prior antineoplaston therapy Prior cytodifferentiating agent allowed