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Clinical Trial Summary

Current therapies for Soft Tissue Sarcoma provide very limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of Soft Tissue Sarcoma.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Soft Tissue Sarcoma.


Clinical Trial Description

Soft Tissue Sarcoma 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 Soft Tissue Sarcoma, 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 Soft Tissue Sarcoma.

- 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00003521
Study type Interventional
Source Burzynski Research Institute
Contact
Status Terminated
Phase Phase 2
Start date June 14, 1996
Completion date August 30, 2003

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