antineoplaston therapy in treating patients with brain stem glioma

Conditions: Brain Stem Gliomas

Summary: rationale: current therapies for a brain stem glioma provide very limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of brain stem gliomas. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on children (\> 6 months of age) and adults with newly-diagnosed or recurrent brain stem gliomas.

objectives: * to determine the efficacy of antineoplaston therapy in patients with a brain stem glioma, as measured by an objective response to therapy (complete response, partial response or stable disease). * to determine the safety and tolerance of antineoplaston therapy in patients with a brain stem glioma. overview: this is a single arm, open-label study in which patients receive gradually escalating doses of intravenous antineoplaston therapy (atengenal + astugenal) until the maximum tolerated dose is reached. treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. after 12 months, patients with a complete or partial response or with stable disease may continue treatment. to determine objective response, tumor size in measured utilizing mri scans, which are performed every 8 weeks for the first 2 years, every 3 months for the 3rd and 4th years, every 6 months for the 5th and 6th years, and annually thereafter. projected accrual: a total of 20-40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed (except if medically contraindicated) brain stem glioma that is unlikely to respond to existing therapy and for which no curative therapy exists. * tumor must be at least 5 mm in maximum diameter patient characteristics: age: * 6 months or greater performance status: * karnofsky 60-100% life expectancy: * at least 2 months hematopoietic: * wbc at least 2,000/mm\^3 * platelet count greater than 50,000/mm\^3 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 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 participation * no serious active infections or fever * no other serious concomitant disease prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy * no concurrent immunomodulating agents chemotherapy: * at least 4 weeks since prior chemotherapy (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 before study entry) radiotherapy: * at least 8 weeks since prior radiotherapy surgery: * not specified other: * no prior antineoplaston therapy

Keywords: recurrent adult brain stem glioma untreated adult brain stem glioma untreated childhood brain stem glioma recurrent childhood brain stem glioma