antineoplaston therapy in treating children with recurrent or refractory high-grade glioma

Conditions: High Grade Glioma

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

objectives: * to determine the efficacy of antineoplaston therapy in children with recurrent/progressive high grade gliomas, 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 children with recurrent/progressive high grade gliomas. overview: this is a single arm, open-label study in which children with recurrent/progressive high grade gliomas 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 is measured utilizing mri scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter. projected accrual: a total of 20-40 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed high-grade glioma (glioblastoma multiforme or anaplastic astrocytoma) that is recurrent or progressive or with residual tumor after standard therapy, including radiotherapy * measurable tumor by mri scan performed within two weeks prior to study entry * male or female patients * children 6 months to 17 years * performance status: karnofsky 60-100% * life expectancy of at least 2 months * wbc greater than 1,500/mm\^3 * platelet count greater than 50,000/mm\^3 * no evidence of hepatic or renal insufficiency and a total bilirubin and serum creatinine no greater than 2.5 mg/dl and sgot/sgpt no greater than 5 times upper limit of normal * must have recovered from adverse effect of previous therapy * at least 8 weeks elapsed since last dose of radiation * at least 4 weeks elapsed since last dose of chemotherapy (6 weeks for nitrosoureas) * corticosteroids permitted using the smallest dose that is compatible with preservation of optimal neurologic function * acceptable methods of birth control (in females of child-bearing potential or in sexually active males)during and up to four weeks following completion of study exclusion criteria: * prior a10 and as2-1 treatment * severe heart disease * uncontrolled hypertension * lung disease * hepatic failure * serious active infections, fever or other serious concurrent disease that would interfere with the evaluation of the treatment drug. * pregnant or nursing * serious concurrent disease * concurrent antineoplastic or immunomodulatory agents

Keywords: childhood anaplastic astrocytoma childhood glioblastoma multiforme