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 studies the effectiveness of antineoplaston therapy in treating patients who have low-grade astrocytoma.


Study summary:

OBJECTIVES: - Determine the safety and possible effectiveness of antineoplastons A10 and AS2-1 in patients with low-grade astrocytoma. - Describe response to, tolerance to, and side effects of this regimen in these patients. OUTLINE: This is an open-label study. Patients receive gradually escalating doses of antineoplaston A10 and antineoplaston AS2-1 by intravenous injection 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Tumors are measured every 2 months for 1 year and then every 3 months for 1 year. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed low-grade astrocytoma that has progressed, recurred, or persisted after initial therapy, including radiotherapy - Previously treated with at least 1 prior standard therapy (e.g., radiotherapy, chemotherapy, immunotherapy, or cytodifferentiating agent) - Must have failed standard therapy - Measurable disease by MRI or CT scan - Tumor must be at least 5 mm - No brain stem tumors PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 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 and SGPT no greater than 5 times upper limit of normal - No hepatic failure Renal: - Creatinine no greater than 2.5 mg/dL - No renal insufficiency - No history of renal conditions that contraindicate high dosages of sodium Cardiovascular: - No uncontrolled hypertension - No chronic heart failure - No history of congestive heart failure - No history of other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No severe lung disease (e.g., chronic obstructive pulmonary disease) Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for 4 weeks after study participation - No other concurrent serious disease - No active infection PRIOR CONCURRENT THERAPY: Biologic therapy: - See Disease Characteristics - At least 4 weeks since prior immunotherapy and recovered - No concurrent immunomodulating agents Chemotherapy: - See Disease Characteristics - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since prior radiotherapy and recovered Surgery: - Must recover from prior surgery Other: - No prior antineoplastons


NCT ID:

NCT00003471


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 21, 2017

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