Antineoplaston Therapy in Treating Patients With Stage IV Lung Cancer

Status Terminated

Clinical Trial Summary

Current therapies for Stage IV lung 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 IV lung cancer.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV lung cancer.

Clinical Trial Description

OVERVIEW: This is a single arm, open-label study in which patients with Stage IV lung cancer 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 Stage IV lung 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 IV lung 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	NCT00003491
Study type	Interventional
Source	Burzynski Research Institute
Contact
Status	Terminated
Phase	Phase 2
Start date	March 20, 1996
Completion date	July 31, 1998

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