A Study of the Safety and Biological Activity of Intraperitoneal (IP) EGEN-001 Administered Alone and in Combination With Standard Chemotherapy in Colorectal Peritoneal Carcinomatosis Patients

Colorectal Cancer Clinical Trial

Official title: A Phase I/II Study of the Safety and Biological Activity of Intraperitoneal EGEN-001 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered Alone and in Combination With Standard Chemotherapy in Colorectal Peritoneal Carcinomatosis Patients Who Had Previously Received Cytoreductive Surgery Plus Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Therapy

Status Terminated

Clinical Trial Summary

Colorectal cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the body to produce cytokines.Therefore Therefore, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells.

Clinical Trial Description

This multi-center, Phase I/II study will be conducted with an open-label, non-randomized design. The study will enroll up to 30 patients who had gone through cytoreductive surgery and HIPEC treatment 6-8 weeks prior to enrollment. Patients will be treated with EGEN-001 24 mg/m2 intra-peritoneally (IP) once every week for 12 weeks and then once every two weeks until disease progression or intolerable toxicity, but for no more than one year. Patients who develop progressive metastases will receive standard chemotherapy concomitant with EGEN-001. Hence, the initial EGEN-001 treatment period will be without chemotherapy. The standard chemotherapy regimen will be FOLFOX or FOLFIRI administered every 2-3 weeks. Patient with progressive disease a second time will be taken off-study. Those who remain progression-free will receive EGEN-001 for up to one year. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer

• NCT number: NCT01300858
• Study type: Interventional
• Source: EGEN, Inc.
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: June 2011
• Completion date: July 2014