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

Inclusion Criteria

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