Stage IV Breast Cancer, Recurrent Breast Cancer
Conditions
Brief 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.
Detailed description
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.
Interventions
PROCEDUREalternative product therapy
PROCEDUREbiological therapy
PROCEDUREbiologically based therapies
PROCEDUREcancer prevention intervention
PROCEDUREdifferentiation therapy
Sponsors
Burzynski Research Institute
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed