Safety Study of phIL-12-005/PPC to Treat Recurrent Ovarian Cancer

Summary

Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the cells of the body. Because the genes are damaged, the body is unable to produce a group of proteins called cytokines which are used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 (phIL-12-005/PPC) contains the human gene for interleukin-12 \[IL-12\] (a cytokine) in a special carrier system designed to enter the cells and help the body produce cytokines. This study has two purposes; the first is to determine what different strengths of EGEN-001 can be given safely without major side effects, and the second is to see if EGEN-001 is able to slow down the growth of ovarian cancer.

Timeline

Start

2005-08

Primary completion

2006-10

Completion

2006-10

Outcome

Outcome not reported

Stopped: “Sponsor decided to terminate the study early so they could begin a second dose-escalation study of EGEN-001 in combination with standard chemotherapy.”

Drugs

Indications