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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

June 21, 2002
June 25, 2002
November 2, 2006
May 2002
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Complete list of historical versions of study NCT00040170 on ClinicalTrials.gov Archive Site
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Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer
Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Prostatic Neoplasms
Biological: MVA-MUC1-IL2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
Same as current
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Inclusion Criteria:

  • Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria:

  • Metastasis or local disease
  • Prior hormone treatment
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00040170
TG4010.03
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Transgene
  • University of California, Los Angeles
  • The Cleveland Clinic
  • University of Arizona
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Transgene
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP