Antineoplaston Therapy in Treating Patients With Stage III or Stage IV Prostate Cancer

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: Antineoplaston therapy (Atengenal + Astugenal)

• Registration Number: NCT00003516
• Lead Sponsor: Burzynski Research Institute

Brief Summary

Current therapies for Stage III or 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 Stage III or Stage IV Prostate Cancer.

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

Detailed Description

Stage III or Stage IV Prostate Cancers receive Antineoplaston A10 and AS2-1 capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity.

OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in patients with Stage III or 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 Stage III or Stage IV Prostate Cancer.

* To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 4 months for 2 years, every 6 months for 2 years, and then annually for 2 years thereafter.

Study Timeline

• Study Start: 1996-03-27
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-03-18
• Study Completion: 2004-03-18
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-01
• Last Update Posted: 2018-02-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Antineoplastons	Antineoplaston therapy (Atengenal + Astugenal)	Antineoplaston therapy (Atengenal + Astugenal) capsules orally six to seven times a day. Treatment continues in the absence of disease progression or unacceptable toxicity. absence of disease progression or unacceptable toxicity.

Trial Locations

Locations (1)

Burzynski Clinic; 🇺🇸 Houston, Texas, United States