Trial | NCT00040170  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    50
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.
Study Started
May 31
2002
Last Update
Nov 02
2006
Estimate

Biological MVA-MUC1-IL2

Criteria 

Inclusion Criteria:

Rising PSA after surgery or radiation for prostate cancer

Exclusion Criteria:

Metastasis or local disease
Prior hormone treatment
No Results Posted