Brain Stem Gliomas Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 In Patients With Brain Stem Glioma
RATIONALE: Current therapies for a brain stem glioma 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 stem gliomas.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on children (> 6 months of age) and adults with newly-diagnosed or
recurrent brain stem gliomas.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with a brain stem
glioma, 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 a brain
stem glioma.
OVERVIEW: This is a single arm, open-label study in which patients 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 in measured utilizing MRI scans, which are
performed every 8 weeks for the first 2 years, every 3 months for the 3rd and 4th years,
every 6 months for the 5th and 6th years, and annually thereafter.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.
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