Antineoplaston Therapy in Treating Children With Visual Pathway Glioma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed (unless medically contraindicated) visual pathway glioma, which is not amenable to standard therapy or did not respond to standard therapy.
• •Evidence of tumor by MRI scan performed within 2 weeks prior to the study entry
• •Tumor must be at least 5 mm
• •No brain stem tumors
• •PATIENT CHARACTERISTICS:
• •Age:
• •6 months to 17 years
• •Performance status:
• •Karnofsky 60-100%
• •Life expectancy:
• •At least 2 months
• •Hematopoietic:
• •WBC at least 2000/mm3
• •Platelet count greater than 50,000/mm3
• •Hepatic:
• •Bilirubin no greater than 2.5 mg/dL
• •SGOT/SGPT no greater than 5 times upper limit of normal
• •No hepatic failure
• •Renal:
• •Creatinine no greater than 2.5 mg/dL
• •No renal insufficiency
• •No history of renal conditions that contraindicate high dosages of sodium
• •Cardiovascular:
• •No severe heart disease
• •No uncontrolled hypertension
• •No history of congestive heart failure
• •No other cardiovascular conditions that contraindicate high dosages of sodium
• •Pulmonary:
• •No severe lung disease
• •Other:
• •Not pregnant or nursing
• •Fertile patients must use effective contraception during and for 4 weeks after study
• •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 and recovered (6 weeks for nitrosoureas)
• •No concurrent antineoplastic agents
• •Endocrine therapy:
• •Concurrent corticosteroids for cerebral edema allowed (must be on stable dose for at least 1 week prior to study)
• •Radiotherapy:
• •At least 8 weeks since prior radiotherapy and recovered
• •Surgery:
• •Not specified
• •Other:
• •No prior antineoplaston therapy