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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Patients will be treated with EGEN-001 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.
Midwestern Regional Medical Center
Zion, Illinois, United States
Progression-free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Tumor Growth Assessment by X-ray/CT
Time frame: 1 year
Number of study subjects with adverse events
Time frame: 5 years
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