Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer

Stage IV Prostate Cancer Clinical Trial

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

Status Withdrawn

Clinical Trial Summary

Current therapies for Refractory Stage IV Prostate 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 Refractory Stage IV Prostate Cancer.

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

Clinical Trial Description

Refractory Stage IV Prostate 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 Refractory Stage IV Prostate 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 Refractory Stage IV Prostate 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. ;

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage IV Prostate Cancer

• NCT number: NCT00003534
• Study type: Interventional
• Source: Burzynski Research Institute
• Status: Withdrawn
• Phase: Phase 2
• Start date: October 11, 1996
• Completion date: February 20, 1997