Expired Study
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Tucson, Arizona 85724


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Rising PSA after surgery or radiation for prostate cancer Exclusion Criteria: - Metastasis or local disease - Prior hormone treatment


Study is Available At:


Original ID:

TG4010.03


NCT ID:

NCT00040170


Secondary ID:


Study Acronym:


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


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Transgene


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

50


Enrollment Type:


Study Dates

Start Date:May 2002
Verification Date:October 2006
Last Changed Date:October 31, 2006
First Received Date:June 21, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Biological
Name:MVA-MUC1-IL2

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Transgene
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of California, Los Angeles

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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