OVERVIEW: This is a single arm, open-label study in which adults (≥ 18 years of age) with newly diagnosed 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 newly diagnosed Glioblastoma Multiforme, 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 newly diagnosed 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.
