CNS Tumor Clinical Trial
Official title:
Phase II Study of Antineoplastons A19 and AS2-1 in Patients With Neurofibroma and Schwannoma
RATIONALE: Current therapies for adults with a recurrent/residual Neurofibroma or Schwannoma
provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy
suggest that it may prove beneficial in the treatment of adults with a recurrent/residual
Neurofibroma or Schwannoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on adults with a recurrent/residual Neurofibroma or Schwannoma.
OVERVIEW: This is a single arm, open-label study in which adults with a recurrent/residual
Neurofibroma or Schwannoma 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/residual
Neurofibroma or Schwannoma, 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/residual Neurofibroma or Schwannoma.
- 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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