Non-hodgkins Lymphoma Clinical Trial
Official title:
Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, High Grade
Current therapies for Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma
provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston
therapy suggest that it may prove beneficial in the treatment of Refractory or Recurrent
High-Grade Stage II - IV Non-Hodgkin's Lymphoma.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Refractory or Recurrent High-Grade Stage II - IV
Non-Hodgkin's Lymphoma.
Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma patients 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 Refractory or
Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma, 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
Refractory or Recurrent High-Grade Stage II - IV Non-Hodgkin's Lymphoma.
- To determine objective response, tumor size is measured utilizing physical examination,
radiologic studies, and bone marrow biopsies as necessary, 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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