Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer

Phase 2

Terminated

• Conditions: Prostatic Neoplasms

• Registration Number: NCT00040170
• Lead Sponsor: Transgene

Brief Summary

This study involves the use of an experimental product, TG4010. The purpose of the study is to determine if TG4010 can stimulate the body's immune system to help it fight the cancer.

Detailed Description

The experimental product, TG4010, is a modified vaccinia virus (already used in humans) into which two (2) genes have been placed. One gene is for a protein (MUC1) found in cancer cells. The second gene is for human interleukin 2 (IL2) which the body's immune system makes to help it fight cancer. The TG4010 is given as an injection under the skin (subcutaneous) once a week for six weeks followed by a schedule of every three weeks or every three weeks for the first twelve (12) weeks. If the therapy is working, it can be continued for up to 9 months until no further improvement or until the patient gets worse for as long as it is tolerated.

Study Timeline

• Study Start: 2002-05
• Study First Submitted: 2002-06-21
• Study First Submitted QC: 2002-06-24
• Study First Posted: 2002-06-25
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-31
• Last Update Posted: 2006-11-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria

• Metastasis or local disease
• Prior hormone treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (3)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

UCLA; 🇺🇸 Los Angeles, California, United States