Clinical Trials Logo

Clinical Trial Summary

Current therapies for Stage IV Cancer of the Cervix and/or Vulva 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 Cancer of the Cervix and/or Vulva.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on patients with Stage IV Cancer of the Cervix and/or Vulva.


Clinical Trial Description

Stage IV Cancer of the Cervix and/or Vulva 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 Cancer of the Cervix and/or Vulva, 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 Cancer of the Cervix and/or Vulva.

- 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 NCT00003525
Study type Interventional
Source Burzynski Research Institute
Contact
Status Terminated
Phase Phase 2
Start date June 3, 1996
Completion date January 22, 1998

See also
  Status Clinical Trial Phase
Completed NCT03339765 - Self-Advocacy Serious Game in Advanced Cancer N/A