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 August 1998
Trial size 40 participants
Trial identifier NCT00003474, BRI-BT-20, CDR0000066511


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 confirmed incurable glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy) - Measurable disease by MRI or CT scan - Brain stem tumor is excluded - Tumor must be at least 5 mm PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - At least 2 months Hematopoietic: - WBC at least 2,000/mm3 - Platelet count at least 50,000/mm3 Hepatic: - No liver failure - Bilirubin no greater than 2.5 mg/dL - SGOT/SGPT no greater than 5 times upper limit Renal: - No history of renal conditions that contraindicate high dosages of sodium - Creatinine no greater than 2.5 mg/dL Cardiovascular: - No uncontrolled hypertension - No history of congestive heart failure - No other cardiovascular conditions that contraindicate high dosages of sodium Pulmonary: - No serious lung disease (e.g., severe COPD) Other: - Not pregnant or nursing - Fertile patients must use adequate contraception during and for 4 weeks after study - No active infection - No other serious medical or psychiatric conditions PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since immunotherapy - No concurrent immunomodulating agents Chemotherapy: - See Disease Characteristics - At least 4 weeks since chemotherapy (unless radiologically proven progression) - At least 6 weeks since nitrosoureas Endocrine therapy: - Corticosteroids allowed Radiotherapy: - See Disease Characteristics - At least 8 weeks since radiotherapy (unless radiologically proven progression) Surgery: - Recovered from prior surgery Other: - No prior antineoplaston therapy - Prior cytodifferentiating agent allowed

Additional Information

Official title Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Glioblastoma Multiforme
Description OBJECTIVES: - Study the safety and effectiveness of antineoplastons A10 and AS2-1 in patients with incurable glioblastoma multiforme. - Describe response, 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 six times a day until the maximum tolerated dose is reached. Patients achieving complete response (CR) continue treatment for an additional 8 months after reaching CR. Treatment continues for at least 3 months in the absence of unacceptable toxicity or disease progression. Tumors are measured every 2 months during the first year and every 3 months during the second year. PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued in this study.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).