Antineoplaston Therapy in Treating Women With Stage IV Breast Cancer

You may be eligible if

• 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