Stage IV Ovarian Cancer Clinical Trial
Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Carcinoma of the Ovary
Current therapies for Stage III or IV Ovarian Cancer provide very limited benefit to the
patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
beneficial in the treatment of Stage III or IV Ovarian Cancer.
PURPOSE: This study is being performed to determine the effects (good and bad) that
Antineoplaston therapy has on patients with Stage III or IV Ovarian Cancer.
Stage III or IV Ovarian Cancer 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 Stage III or IV
Ovarian Cancer, 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 Stage
III or IV Ovarian Cancer.
- 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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