antineoplaston therapy in treating women with stage iv breast cancer

Conditions: Stage IV 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 studies the effectiveness of antineoplaston therapy in treating women who have stage iv breast cancer that has not responded to previous therapy.

overview: this is a single arm, open-label study in which patients with stage iv breast cancer receive gradually escalating doses of intravenous antineoplaston therapy (atengenal + astugenal) until the maximum tolerated dose is reached. treatment continues up to12 months in the absence of disease progression or unacceptable toxicity. objectives: * to determine the efficacy of antineoplaston therapy in patients with stage iv breast cancer, as measured by an objective response to therapy (complete response, partial response or stable disease). * to determine the safety and tolerance of antineoplaston therapy in patients with stage iv breast cancer. * to determine objective response, tumor size is measured utilizing mri scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

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 * 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

Keywords: recurrent breast cancer