PROSTVAC®-VF/TRICOM™ Vaccine for the Treatment of Metastatic Prostate Cancer After Failing Hormone Therapy

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00078585
• Lead Sponsor: Bavarian Nordic

Brief Summary

PROSTVAC-VF is an investigational cancer vaccine. The vaccine is based on the theory that the immune system can be taught to fight cancer by directing the immune system to attack specific targets found on cancer cells. These targets are called Tumor Associated Antigens, or TAA's. This trial will help determine if this vaccine can help fight cancer.

This multi-center, double-blind, randomized, empty vector-controlled trial is designed to evaluate the safety and efficacy of PROSTVAC-VF/TRICOM co-administered with GM-CSF versus the empty viral vector co-administered with placebo in the treatment of patients with androgen-independent prostate cancer (AIPC).

All patients will be required to sign an informed consent prior to the performance of any on-study procedures. Patients will be screened for eligibility within 14 days prior to vaccine administration. Patients who meet all inclusion and exclusion criteria will be centrally randomized into the study and will receive a unique patient identification number and a blinded treatment assignment. The ratio of active treatment to empty vector control (placebo) is 2:1.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2004-03-01
• Study First Submitted QC: 2004-03-02
• Study First Posted: 2004-03-03
• Primary Completion: 2006-01-04
• Study Completion: 2009-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (47)

Urology Centers of Alabama; 🇺🇸 Homewood, Alabama, United States

Alaska Clinical Research Center; 🇺🇸 Anchorage, Alaska, United States

Urology Associates of Central California; 🇺🇸 Fresno, California, United States

San Diego Urology Center; 🇺🇸 La Mesa, California, United States

Loma Linda University; 🇺🇸 Loma Linda, California, United States

Atlantic Urology Medical Group; 🇺🇸 Long Beach, California, United States

Pacific Clinical Research; 🇺🇸 Santa Monica, California, United States

Western Clinical Research, Inc.; 🇺🇸 Torrance, California, United States

UCHSC Anschutz Cancer Pavilion; 🇺🇸 Aurora, Colorado, United States

Connecticut Clinical Research Center; 🇺🇸 Waterbury, Connecticut, United States

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