antineoplaston therapy in treating patients with ependymoma

Conditions: Ependymoma

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

objectives: * to determine the efficacy of antineoplaston therapy in patients with ependymoma 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 ependymoma overview: this is a single arm, open-label study in which patients with ependymoma 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 ependymoma that is unlikely to respond to existing therapy and for which no curative therapy exists * evidence of residual tumor (\>= 5mm) by mri scan performed within two weeks prior to study entry * no brain stem tumors patient characteristics: age: * 6 months and over performance status: * karnofsky 60-100% life expectancy: * at least 2 months hematopoietic: * wbc at least 2,000/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 failure * 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 history of 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

Keywords: ependymoma anaplastic ependymoma