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

Tracking Information
First Received Date ^ICMJE	June 21, 2002
Last Updated Date	October 31, 2006
Start Date ^ICMJE	May 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00040170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer
Official Title ^ICMJE	Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate
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.
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Prostatic Neoplasms
Intervention ^ICMJE	Biological: MVA-MUC1-IL2
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	50
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Rising PSA after surgery or radiation for prostate cancer Exclusion Criteria: Metastasis or local disease Prior hormone treatment
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00040170
Responsible Party
Study ID Numbers ^ICMJE	TG4010.03
Study Sponsor ^ICMJE	Transgene
Collaborators ^ICMJE	University of California, Los Angeles The Cleveland Clinic University of Arizona
Investigators ^ICMJE
Information Provided By	Transgene
Verification Date	October 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP