Non-hodgkins Lymphoma Clinical Trial
Official title:
Phase II Study of Antineoplaston A10 and AS2-1 in Patients With Non-Hodgkin's Lymphoma, Intermediate Grade
Current therapies for Refractory or Recurrent Intermediate-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 Intermediate-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 Intermediate-Grade Stage
II - IV Non-Hodgkin's Lymphoma.
Refractory or Recurrent Intermediate-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 Intermediate-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 Intermediate-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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