High Grade Glioma Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Children With High Grade Glioma
RATIONALE: Current therapies for children with recurrent/progressive high grade 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 children with
recurrent/progressive high grade gliomas.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on children (> 6 months of age) with recurrent/progressive high
grade gliomas.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in children with
recurrent/progressive high grade 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 children with
recurrent/progressive high grade gliomas.
OVERVIEW: This is a single arm, open-label study in which children with recurrent/progressive
high grade 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 for this study.
;
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