Waldenstrom Macroglobulinemia Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Macroglobulinemia of Waldenstrom
Current therapies for Recurrent or Refractory Waldenstrom's Macroglobulinemia provide very
limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest
that it may prove beneficial in the treatment of Recurrent or Refractory Waldenstrom's
Macroglobulinemia.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Recurrent or Refractory Waldenstrom's
Macroglobulinemia.
Recurrent or Refractory Waldenstrom's Macroglobulinemia patients receive gradually escalating
doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum
tolerated dose is reached. Treatment continues up to 12 months in the absence of disease
progression or unacceptable toxicity.
OBJECTIVES:
- To determine the efficacy of Antineoplaston therapy in patients with Recurrent or
Refractory Waldenstrom's Macroglobulinemia, 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
Recurrent or Refractory Waldenstrom's Macroglobulinemia.
- 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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