Ovarian Neoplasms
Conditions
Brief 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
Detailed description
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.
Interventions
GENETICEGEN-001 (phIL-12-005/PPC)
In stage 1, patients will receive standard doses of IV carboplatin and docetaxel for 2 treatment cycles with a 3 week interval. Patients will also receive 4 IP infusions of EGEN-001 at 12mg/m2 EGEN-001, 18mg/m2, or 24mg/m2, 10-11 days apart. Stage 2 of the study will involve cycle escalation at the highest EGEN-001 dose identified from Stage 1. All patients will receive up to 8 doses of EGEN-001, 10-11 days apart plus up to 4 IV carboplatin and docetaxel cycles with 3 week intervals. After receiving the assigned number of treatments of EGEN-001, carboplatin, and docetaxel, patients may continue to receive up to 4 additional infusions of EGEN-001 and 2 IV carboplatin and docetaxel cycles with 3 week intervals.
Sponsors
EGEN, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer. | 12-14 months |
Secondary
| Measure | Time frame |
|---|---|
| Examine the optimal EGEN-001 treatment regimen in combination with carboplatin and docetaxel in recurrent, platinum-sensitive ovarian cancer, and assess EGEN-001's impact on tumor, CA-125, and activity markers of biological activity. | 10 months |
Countries
United States
Outcome results
None listed