antineoplaston therapy in treating patients with low-grade astrocytoma

Conditions: Low-Grade Astrocytoma, Nos

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

overview: this is a single arm, open-label study in which adults with a recurrent/progressive low grade astrocytoma 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. objectives: * to determine the efficacy of antineoplaston therapy in adults with a recurrent/progressive low grade astrocytoma, 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 a recurrent/progressive low grade astrocytoma. * 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 or cytologically confirmed low-grade astrocytoma that has progressed, recurred, or persisted after initial therapy, including radiotherapy * previously treated with at least 1 prior standard therapy (e.g., radiotherapy, chemotherapy, immunotherapy, or cytodifferentiating agent) * measurable tumor by mri scan performed within two weeks prior to study entry * tumor must be at least 5 mm * no brain stem tumors patient characteristics: age: * 18 and over performance status: * karnofsky 60-100% life expectancy: * more than 2 months hematopoietic: * wbc at least 2,000/mm\^3 * platelet count at least 50,000/mm\^3 hepatic: * bilirubin no greater than 2.5 mg/dl * sgot and sgpt no greater than 5 times upper limit of normal * no hepatic failure renal: * creatinine no greater than 2.5 mg/dl * no renal insufficiency * no history of renal conditions that contraindicate high dosages of sodium cardiovascular: * no uncontrolled hypertension * no chronic heart failure * no history of congestive heart failure * no history of other cardiovascular conditions that contraindicate high dosages of sodium pulmonary: * no severe lung disease (e.g., chronic obstructive pulmonary disease) other: * not pregnant or nursing * fertile patients must use effective contraception during and for 4 weeks after study participation * no other concurrent serious disease * no active infection prior concurrent therapy: biologic therapy: * see disease characteristics * at least 4 weeks since prior immunotherapy and recovered * no concurrent immunomodulating agents chemotherapy: * see disease characteristics * at least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) and recovered * no concurrent antineoplastic agents endocrine therapy: * concurrent corticosteroids allowed radiotherapy: * see disease characteristics * at least 8 weeks since prior radiotherapy and recovered surgery: * must recover from prior surgery other: * no prior antineoplastons

Keywords: recurrent/progressive adult low grade astrocytoma