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Brief Title: Antineoplaston Therapy in Treating Patients With Primary Liver Cancer
Official Title: Phase II Study of Antineoplaston A10 in Patients With Primary Liver Cancer
Study ID: NCT00003530
Brief Summary: Current therapies for Primary Liver 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 Primary Liver Cancer. PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with advanced Head and Neck Cancer.
Detailed Description: Primary Liver 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 advanced Primary Liver 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 advanced Primary Liver 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.
Minimum Age: 14 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Burzynski Clinic, Houston, Texas, United States
Name: Stanislaw R. Burzynski, MD, PhD
Affiliation: Burzynski Research Institute
Role: PRINCIPAL_INVESTIGATOR