Antineoplaston Therapy in Treating Women With Advanced Breast Cancer

Burzynski Research Institute

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Stage IV Breast Cancer Recurrent Breast Cancer

Interventions

antineoplaston A10DRUG

antineoplaston AS2-1DRUG

alternative product therapyPROCEDURE

biological therapyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Burzynski Clinic

Houston, Texas, United States

Data from ClinicalTrials.gov

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