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

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ClinicalTrials.gov Identifier: NCT00040170
Recruitment Status : Terminated
First Posted : June 25, 2002
Last Update Posted : November 2, 2006
Sponsor:
Collaborators:
University of California, Los Angeles
The Cleveland Clinic
University of Arizona
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Biological: MVA-MUC1-IL2 Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate
Study Start Date : May 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00040170     History of Changes
Obsolete Identifiers: NCT00040976
Other Study ID Numbers: TG4010.03
First Posted: June 25, 2002    Key Record Dates
Last Update Posted: November 2, 2006
Last Verified: October 2006

Keywords provided by Transgene:
Adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases