Phase II Study of Antineoplastons A10 and AS2-1 in Children With Primary Malignant Brain Tumors

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed incurable primary malignant brain tumor that has progressed,
recurred, or persisted after initial therapy

- Must have failed prior standard therapy

- No brain stem glioma

- Evidence of tumor by MRI or CT scan

PATIENT CHARACTERISTICS:

Age:

- 6 months to 17 years

Performance status:

- Karnofsky 60-100%

Life expectancy:

- At least 2 months

Hematopoietic:

- WBC at least 1,500/mm^3

- Platelet count greater than 50,000/mm^3

Hepatic:

- No hepatic failure

- Bilirubin no greater than 2.5 mg/dL

- SGOT/SGPT no greater than 5 times upper limit of normal

Renal:

- Creatinine no greater than 2.5 mg/dL

Cardiovascular:

- No severe heart disease

- No uncontrolled hypertension

Pulmonary:

- No severe lung disease

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception during and for 4 weeks after study
participation

- No serious active infections or fever

- No other serious concurrent disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

- No concurrent immunomodulating agents

Chemotherapy:

- At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered

- No concurrent antineoplastic agents

Endocrine therapy:

- Recovered from prior endocrine therapy

- Concurrent corticosteroids for cerebral edema allowed

Radiotherapy:

- At least 8 weeks since prior radiotherapy (unless clear radiological evidence of
progression) and recovered

Surgery:

- At least 4 weeks since prior surgery (unless clear radiological evidence of
progression) and recovered

Other:

- No prior antineoplaston therapy