Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Glioblastoma Multiforme

Inclusion 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