Safety Study of phIL-12-005/PPC to Treat Recurrent Ovarian Cancer
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open Label, Dose Escalation Study of the Safety, Tolerability and Preliminary Efficacy of Intraperitoneal EGEN-001 in Patients With Recurrent Epithelial Ovarian Cancer|
- To determine the maximum tolerated dose (MTD) and to assess the spectrum of toxicities of EGEN-001 when administered by intraperitoneal (IP) infusion in patients with recurrent epithelial ovarian cancer [ Designated as safety issue: Yes ]
- To assess the preliminary efficacy of EGEN-001 by monitoring detectable tumor burden in patients with recurrent epithelial cancer
- To assess EGEN-001 distribution by measuring human interleukin-12 plasmid (phIL-12) DNA copy number in the blood and peritoneal fluid
- To assess the biological effects of EGEN-001 on cytokine production by measuring interferon (IFN) gamma and interleukin-12 (IL-12) concentrations in the blood and peritoneal fluid
|Study Start Date:||August 2005|
|Study Completion Date:||October 2006|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
EGEN-001-101 is a Phase 1, open label, non-randomized, dose escalation study in up to 18 (eighteen) patients (three to six patients in each of the first three cohorts, and up to nine patients in a fourth cohort or MTD). The fourth cohort (or MTD, if earlier) will be expanded in increments of three patients until a total of 18 patients have been enrolled.
Each patient will provide written dated informed consent prior to undergoing eligibility screening for entry into the study. Screening evaluations will be performed within 21 days prior to scheduled study drug administration. If all eligibility criteria are met, the patient will be enrolled and will be scheduled for placement of the IP catheter at least 7 days prior to the scheduled dosing (Day -7) to allow adequate time for healing around the catheter insertion site. Baseline evaluations will be performed prior to dosing. At that time the investigator will ensure that the patient remains eligible for participation.
All study drug will be administered on an inpatient basis and the patient will remain confined for 24 hours following study drug administration for evaluation of safety and collection of specified body fluid samples for plasmid IL-12-DNA and cytokine determinations. Each patient will receive the same dose of EGEN-001 once weekly for four weeks (administered on Day 0, Day 7, Day 14, and Day 21). Patients will undergo safety evaluations 1, 4 and 24 hours and 3 days following each dose. Patients will return to the clinic for safety evaluations three days, one week and five weeks (± one week) following the last dose.
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Ronald Alvarez, MD||Divison of Gynecologic Oncology at University of Alabama at Birmingham|