Low-Grade Astrocytoma, Nos Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Adult Patients With Low Grade Astrocytoma
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT05934630 -
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