NCT00003534

Antineoplaston Therapy in Treating Patients With Refractory Stage IV Prostate Cancer

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Burzynski Research Institute · Academic / Other
• Sex: Male
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Stage IV Prostate Cancer

Interventions

Type	Name	Description
DRUG	Antineoplaston therapy (Atengenal + Astugenal)	Patients With Refractory Stage IV Prostate Cancer will receive Antineoplaston therapy (Atengenal + Astugenal). The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1.

Timeline

• Start date: 1996-10-11
• Primary completion: 1997-02-20
• Completion: 1997-02-20
• First posted: 2003-01-27
• Last updated: 2018-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study