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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.
Age
18 - 99 years
Sex
FEMALE
Healthy Volunteers
No
Burzynski Clinic
Houston, Texas, United States
Start Date
March 5, 1996
Primary Completion Date
October 18, 2002
Completion Date
October 18, 2002
Last Updated
December 12, 2017
7
ACTUAL participants
Antineoplaston therapy (Atengenal + Astugenal)
DRUG
Lead Sponsor
Burzynski Research Institute
NCT04550494
NCT05039801
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