Clinical Trial: Vaccine study of MVA-MUC1-IL2 in patients with Prostate Cancer


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Vaccine study of MVA-MUC1-IL2 in patients with Prostate Cancer

This study is currently recruiting patients.

Sponsored by:	Transgene University of California, Los Angeles Cleveland Clinic Foundation Hospital Arizona Medical Center University of Chicago
Information provided by:	Transgene

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	Treatment or Intervention	Phase
Prostatic Neoplasms	Vaccine: MVA-MUC1-IL2	Phase II

MedlinePlus related topics: Prostate Cancer

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

Further Study Details:

Expected Total Enrollment: 50

Study start: May 2002

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 above, Genders Eligible for Study: Male

Criteria

Inclusion Criteria:

Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria:

Metastasis or local disease
Prior hormone treatment

Location and Contact Information

Arizona
Arizona Cancer Center, Tucson, Arizona, 85724, United States; Recruiting

Carol A Sesma 520-626-9008 csesma@azcc.arizona.edu
Frederick Ahmann, M.D., Principal Investigator

California
UCLA, Los Angeles, California, 90095, United States; Recruiting

Annette Tan 310-267-2336 annettetan@mednet.ucla.edu
Allan J. Pantuck, MD, Principal Investigator

Illinois
University of Chicago, Chicago, Illinois, 60637, United States; Recruiting

Chinyere Okoroh 773-702-6792 cokoroh@medicine.bsd.uchicago.edu
Walter Stalder, MD, Principal Investigator

Ohio
Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States; Recruiting

Jason Rothaermel, RN,BSN 216-445-3741 rothaej@cc.ccf.org
Robert Dreicer, MD, Principal Investigator

More Information

Study ID Numbers: TG4010.03
Record last reviewed: December 2003
Record first received: June 21, 2002
ClinicalTrials.gov Identifier: NCT00040170
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-09

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