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 glioblastoma multiforme.


Study summary:

OBJECTIVES: - Determine the objective response rate to escalating doses of antineoplastons A10 and AS2-1 in patients with glioblastoma multiforme. - Assess tolerance to and side effects of this regimen in these patients. OUTLINE: Patients receive gradually escalating doses of intravenous antineoplaston A10 and antineoplaston AS2-1 6 times daily until the maximum tolerated dose is reached. Treatment continues for at least 2 months in the absence of unacceptable toxicity or disease progression. Patients achieving complete response (CR) continue treatment for an additional 8 months after CR. Tumors are measured after 1 month, every 1-2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: Not specified


Criteria:

DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed glioblastoma multiforme - Tumor subtotally resected or biopsied - Radiologic evidence of residual or recurrent tumor by gadolinium-enhanced MRI, CT scan, or positron-emission tomography - No brain stem tumor PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - More than 4 months Hematopoietic: - WBC at least 1,500/mm^3 - Platelet count at least 50,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - No hepatic failure - Bilirubin no greater than 2.5 mg/dL - SGOT and SGPT no greater than 5 times upper limit of normal Renal: - Creatinine no greater than 2.5 mg/dL - No history of renal conditions that would contraindicate high dosages of sodium Cardiovascular: - No uncontrolled hypertension Other: - Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior immunotherapy - No concurrent immunomodulatory agents Chemotherapy: - No prior chemotherapy - No concurrent antineoplastic agents Endocrine therapy: - Concurrent corticosteroids for cerebral edema allowed Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics - Recovered from any prior surgery


NCT ID:

NCT00003456


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: October 22, 2017

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