antineoplaston therapy in treating adults with residual/recurrent/progressive glioblastoma multiforme

Conditions: Glioblastoma Multiforme of the Brain

Summary: rationale: current therapies for glioblastoma multiforme provide very limited benefit to the patient. the anti-cancer properties of antineoplaston therapy suggest that it may prove beneficial in the treatment of brain tumors. purpose: this study is being performed to determine the effects (good and bad) that antineoplaston therapy has on adults (≥ 18 years of age) with residual/recurrent/progressive glioblastoma multiforme.

overview: this is a single arm, open-label study in which adults (≥ 18 years of age) with residual/recurrent/progressed glioblastoma multiforme 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 (≥ 18 years of age) with residual/recurrent/progressive glioblastoma multiforme following initial therapy, including radiotherapy, 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 (≥ 18 years of age) with residual/recurrent/progressive glioblastoma multiforme. * 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 glioblastoma multiforme that has progressed, recurred, or persisted following completion of initial standard therapy (including radiotherapy and/or chemotherapy) * measurable disease by mri or ct scan * brain stem tumor is excluded * 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 2,000/mm3 * platelet count at least 50,000/mm3 hepatic: * no liver failure * bilirubin no greater than 2.5 mg/dl * sgot/sgpt no greater than 5 times upper limit renal: * no history of renal conditions that contraindicate high dosages of sodium * creatinine no greater than 2.5 mg/dl cardiovascular: * no uncontrolled hypertension * no history of congestive heart failure * no other cardiovascular conditions that contraindicate high dosages of sodium pulmonary: * no serious lung disease (e.g., severe copd) other: * not pregnant or nursing * fertile patients must use adequate contraception during and for 4 weeks after study * no active infection * no other serious medical or psychiatric conditions prior concurrent therapy: biologic therapy: * at least 4 weeks since immunotherapy * no concurrent immunomodulating agents chemotherapy: * see disease characteristics * at least 4 weeks since chemotherapy (unless radiologically proven progression) * at least 6 weeks since nitrosoureas endocrine therapy: * corticosteroids allowed radiotherapy: * see disease characteristics * at least 8 weeks since radiotherapy (unless radiologically proven progression) surgery: * recovered from prior surgery other: * no prior antineoplaston therapy * prior cytodifferentiating agent allowed

Keywords: adult glioblastoma recurrent glioblastoma