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

This study has been terminated.

First Received: June 21, 2002 Last Updated: October 31, 2006 History of Changes

Sponsor:	Transgene
Collaborators:	University of California, Los Angeles The Cleveland Clinic University of Arizona
Information provided by:	Transgene
ClinicalTrials.gov Identifier:	NCT00040170

Purpose

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.

Condition	Intervention	Phase
Prostatic Neoplasms	Biological: MVA-MUC1-IL2	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

U.S. FDA Resources

Further study details as provided by Transgene:

Estimated Enrollment:	50
Study Start Date:	May 2002

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria:

Metastasis or local disease
Prior hormone treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040170

Locations

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

Transgene

University of California, Los Angeles

The Cleveland Clinic

University of Arizona

More Information

No publications provided

Study ID Numbers:	TG4010.03
Study First Received:	June 21, 2002
Last Updated:	October 31, 2006
ClinicalTrials.gov Identifier:	NCT00040170 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Transgene:

Adenocarcinoma of the prostate

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Physiological Effects of Drugs
Urogenital Neoplasms
Genital Diseases, Male
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Sensory System Agents
Interleukin-2
Analgesics, Non-Narcotic
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 09, 2009