Antineoplaston Therapy in Treating Women With Advanced Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed stage IV breast cancer that is unlikely to respond to existing therapy and for which no curative therapy exists
• •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 no 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 renal failure
• •Cardiovascular:
• •No chronic heart failure
• •No uncontrolled hypertension
• •Pulmonary:
• •No severe lung 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
• •No serious malabsorption syndromes
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Recovered from prior immunotherapy
• •At least 4 weeks since prior immunotherapy, except in patients with disease progression during or after initial therapy
• •Chemotherapy:
• •Recovered from prior chemotherapy
• •At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas), except in patients with disease progression during or after initial therapy
• •Endocrine therapy:
• •Recovered from prior hormonal therapy
• •At least 12 weeks since prior hormonal therapy, except in patients with disease progression during and after initial therapy
• •Concurrent corticosteroids for peritumoral edema allowed
• •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
• •No prior extensive stomach or intestinal surgery
• •Other:
• •Prior cytodifferentiating agents allowed
• •No prior antineoplaston therapy
• •No other concurrent therapy for metastatic breast cancer