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Antineoplaston Therapy in Treating Patients With Metastatic or Unresectable Colon Cancer

Colon Cancer Clinical Trial

Official title:
Phase II Study of Antineoplastons A10 and AS2-1 in Patients With Adenocarcinoma of the Colon

Clinical Trial Summary

Current therapies for metastatic or unresectable Colon 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 metastatic or unresectable Colon Cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with metastatic or unresectable Colon Cancer

Clinical Trial Description

OVERVIEW: This is a single arm, open-label study in which patients with metastatic or unresectable Colon Cancer cancer 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 metastatic or unresectable Colon 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 metastatic or unresectable Colon 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00003485
Study type Interventional
Source Burzynski Research Institute
Contact
Status Terminated
Phase Phase 2
Start date April 10, 1996
Completion date May 11, 2003
View Details
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