Back to resultsVaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer
Primary Purpose
Prostatic Neoplasms
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MVA-MUC1-IL2
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Adenocarcinoma of the prostate
Eligibility Criteria
Inclusion Criteria: Rising PSA after surgery or radiation for prostate cancer Exclusion Criteria: Metastasis or local disease Prior hormone treatment
Sites / Locations
- Arizona Cancer Center
- UCLA
- Cleveland Clinic Foundation
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00040170
First Posted
June 21, 2002
Last Updated
October 31, 2006
Sponsor
Transgene
Collaborators
University of California, Los Angeles, The Cleveland Clinic, University of Arizona
1. Study Identification
Unique Protocol Identification Number
NCT00040170
Brief Title
Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer
Official Title
Randomized Multicenter Phase II Study Evaluating Two Dosing Schedules of TG4010(MVA-MUC1-IL2) in Patients With Adenocarcinoma of the Prostate
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Terminated
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Transgene
Collaborators
University of California, Los Angeles, The Cleveland Clinic, University of Arizona
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Adenocarcinoma of the prostate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
MVA-MUC1-IL2
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rising PSA after surgery or radiation for prostate cancer
Exclusion Criteria:
Metastasis or local disease
Prior hormone treatment
Facility Information:
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vaccine Study of MVA-MUC1-IL2 in Patients With Prostate Cancer
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