Overview

This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatments antineoplaston a10, antineoplaston as2-1
Phase phase 2
Sponsor Burzynski Research Institute
Start date November 1998
Trial identifier NCT00003456, BRI-BT-7, CDR0000066488

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 studies the effectiveness of antineoplaston therapy in treating patients who have glioblastoma multiforme.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Primary purpose treatment

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme
Description 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
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).