Antineoplaston Therapy in Treating Children With Primary Malignant Brain Tumors

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