antineoplaston therapy in treating patients with recurrent or refractory mixed gliomas

Conditions: Mixed Gliomas

Summary: rationale: current therapies for adults with recurrent or refractory mixed 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 adults with recurrent or refractory mixed gliomas. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on adults with recurrent or refractory mixed gliomas.

objectives: * to determine the efficacy of antineoplaston therapy in adults with recurrent or refractory mixed 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 adults with recurrent or refractory mixed gliomas. overview: this is a single arm, open-label study in which adults with recurrent or refractory mixed 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 to this study

Eligibility criteria:
disease characteristics: * histologically confirmed incurable primary mixed glioma that is recurrent or refractory following standard therapy, including radiation therapy * evidence of recurrent or refractory tumor by mri scan performed within two weeks prior to study entry * must have received and failed standard therapy * tumor must be at least 5 mm patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * at least 2 months hematopoietic: * wbc at least 2000/mm3 * platelet count at least 50,000/mm3 hepatic: * no hepatic insufficiency * bilirubin no greater than 2.5 mg/ml * sgot and sgpt no greater than 5 times upper limit of normal renal: * no renal insufficiency * creatinine no greater than 2.5 mg/ml * no history of renal conditions that contraindicate high dosages of sodium cardiovascular: * no known chronic heart failure * no uncontrolled hypertension * no history of congestive heart failure * no other cardiovascular conditions that contraindicate high dosages of sodium pulmonary: * no severe lung disease * no severe chronic obstructive pulmonary disease other: * not pregnant or nursing * fertile patients must use effective contraception during and for 4 weeks after study * no other severe medical illness * no nonmalignant systemic disease * no active infection prior concurrent therapy: biologic therapy: * at least 4 weeks since immunotherapy chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) endocrine therapy: * concurrent corticosteroids allowed radiotherapy: * at least 8 weeks since prior radiotherapy (unless there is evidence of disease progression) surgery: * fully recovered from prior surgery other: * prior cytodifferentiating agent allowed * no prior antineoplaston therapy

Keywords: recurrent adult mixed glioma refractoy adult mixed glioma