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Sponsors and Collaborators: |
Transgene University of California, Los Angeles The Cleveland Clinic University of Arizona |
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Information provided by: | Transgene |
ClinicalTrials.gov Identifier: | NCT00040170 |
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 |
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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 |
Estimated Enrollment: | 50 |
Study Start Date: | 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | TG4010.03 |
Study First Received: | June 21, 2002 |
Last Updated: | October 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00040170 |
Health Authority: | United States: Food and Drug Administration |
Adenocarcinoma of the prostate |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms |
Neoplasms Neoplasms by Site |