antineoplaston therapy in treating children with primary malignant brain tumors

Conditions: Childhood Brain Tumor

Summary: rationale: current therapies for children with primary malignant brain tumors provide limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of children with primary malignant brain tumors. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on children with primary malignant brain tumors.

objectives: * to determine the efficacy of antineoplaston therapy in children with primary malignant brain tumors 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 primary malignant brain tumors. overview: this is a single arm, open-label study in which children with primary malignant brain tumors 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 to this study

Eligibility criteria:
disease characteristics: * histologically confirmed incurable primary malignant brain tumor that has progressed, recurred, or persisted after initial therapy (must have failed standard therapy). * evidence of residual tumor by mri performed within two weeks prior to study entry 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

Keywords: childhood anaplastic astrocytoma recurrent childhood anaplastic astrocytoma childhood glioblastoma multiforme recurrent childhood glioblastoma multiforme childhood brainstem glioma recurrent childhood brainstem glioma childhood primitive neuroectodermal tumor recurrent childhood primitive neuroectodermal tumor