safety and efficacy of egen-001 combined with carboplatin and docetaxel in recurrent, platinum-sensitive, ovarian cancer

Conditions: Ovarian Neoplasms

Summary: ovarian 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, the purpose of the egen-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells. funding source - fda oopd

this study has two purposes: * to determine what different strengths and number of doses of egen-001, administered directly into the peritoneal cavity, can be given safely in combination with standard intravenous chemotherapy for ovarian cancer * to evaluate the anti-cancer activity of egen-001 when combined with standard chemotherapy; biological markers of egen-001 activity will be collected and ovarian cancer burden will be evaluated per standard practice.

Eligibility criteria:
inclusion criteria: * be female and at least 18 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation); * histologically/cytologically confirmed epithelial ovarian cancer that meets one of the following criteria: * measurable disease by computed tomography (ct) scan or * malignant ascites, or * serum ca-125 levels; or * clinically evaluable recurrent disease by other criteria. * relapsed, platinum-sensitive, ovarian cancer after induction chemotherapy (at least 6 months since last exposure to platinum based therapy). * eastern cooperative oncology group (ecog) performance score of 0, 1 or 2; * recovered from prior chemotherapy, having adequate bone marrow function: * adequate renal function; * adequate liver function; * if of childbearing potential, have a negative pregnancy test and agree to follow an acceptable method of birth control; * agree to be compliant with the study's requirements; * understand and sign a written informed consent prior to the performance of any study-related procedures. exclusion criteria: * ovarian cancer other than documented epithelial cancer; * intra-abdominal disease \> 5 cm in diameter; * any serious, uncontrolled, intercurrent medical illness or disorder including, but not limited to: * autoimmune disorders * cardiac disorders * diabetes * intrahepatic disease/cancer as documented by ct-scan * an active infection within 4 weeks of study entry; * any condition/anomaly that would interfere with the appropriate placement of the ip catheter for study drug administration * prior treatment with whole abdominal irradiation; * currently receiving or have received any investigational agents within 28 days of study entry; * received prior chemotherapy for ovarian cancer administered by the ip route; * received any chemotherapy between completion of primary chemotherapy for ovarian cancer and study entry (e.g. consolidation therapy); * receipt of immunotherapy and/or any medications with the potential to affect the activity of egen 001; * known history of hiv infection, hepatitis b, or hepatitis c; * known hypersensitivity to any of the components of carboplatin or docetaxel; * life expectancy of less than 3 months; * known, current, recreational drug or alcohol abuse; * breast feeding an infant; * psychiatric illness/social situations which would limit compliance with study requirements; * any other known condition which in the investigator's opinion would make the patient a poor candidate for the study.