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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Arizona Cancer Center
Tucson, Arizona, United States
UCLA
Los Angeles, California, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
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