Antineoplaston Therapy in Treating Adults With Residual/Recurrent/Progressive Glioblastoma Multiforme

You may be eligible if

• 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