Primitive Neuroectodermal Tumor Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Primitive Neuroectodermal Tumor Outside the Central Nervous System
Current therapies for Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors
provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston
therapy suggest that it may prove beneficial in the treatment of Metastatic, Recurrent, or
Refractory Primitive Neuroectodermal Tumors.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Metastatic, Recurrent, or Refractory Primitive
Neuroectodermal Tumors.
OVERVIEW: This is a single arm, open-label study in which patients with Metastatic,
Recurrent, or Refractory Primitive Neuroectodermal Tumors receive gradually escalating doses
of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated
dose is reached. Treatment continues up to12 months in the absence of disease progression or
unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Metastatic,
Recurrent, or Refractory Primitive Neuroectodermal Tumors, 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
Metastatic, Recurrent, or Refractory Primitive Neuroectodermal Tumors.
- 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.
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