antineoplaston therapy in treating women with advanced breast cancer

Conditions: Stage IV Breast Cancer; Recurrent Breast Cancer

Summary: rationale: antineoplastons are naturally-occurring substances that may also be made in the laboratory. antineoplastons may inhibit the growth of cancer cells. purpose: this phase ii trial is studying how well antineoplaston therapy works in treating women with stage iv breast cancer that has not responded to standard therapy.

objectives: * determine the antitumor activity of antineoplastons a10 and as2-1 capsules in patients with advanced breast cancer by determining the proportion of women who experience an objective tumor response. * evaluate the adverse effects of and tolerance to this regimen in these patients. outline: this is an open-label study. patients receive oral antineoplaston a10 and antineoplaston as2-1 6 to 7 times per day. treatment continues for at least 6 weeks. patients achieving complete or partial response may continue on therapy until disease progression or toxic effects occur. patients are followed for survival. projected accrual: a total of 20-40 patients will be accrued for this study.

Eligibility 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