Expired Study
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Houston, Texas 77055


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003455


Primary Contact:

Study Chair
Stanislaw R. Burzynski, MD, PhD
Burzynski Research Institute


Backup Contact:

N/A


Location Contact:

Houston, Texas 77055
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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