A Phase I/II Study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated With PEG-PEI-Cholesterol Lipopolymer) Administered in Combination With Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Who is this study for? Patients with newly diagnosed advanced epithelial ovarian, fallopian tube or primary peritoneal cancer
Status: Recruiting
Location: See all (24) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients must have suspected histologic diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma per pre-treatment biopsies by laparoscopy, or interventional radiology or CT guided core biopsy. Histologic documentation of the original primary tumor is required via the pathology report.

• Patients must have an International Federation of Gynecology and Obstetrics (FIGO) of III or IV.

• Patients with the following histologic epithelial cell types are eligible: High grade serous adenocarcinoma, endometrioid adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, or adenocarcinoma not otherwise specified (N.O.S.).

• Patients must have adequate:

• Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl.

• Renal function: Creatinine ≤1.5 x institutional upper limit normal (ULN).

• Hepatic function: Bilirubin ≤ 1.5 x ULN. SGOT (AST) and SGPT (ALT) ≤ 3.0 x ULN and alkaline phosphatase ≤ 2.5 x ULN.

• Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.

• Patients should be free of active infection requiring parenteral antibiotics or a serious uncontrolled medical illness or disorder within four weeks of study entry.

• Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to the first treatment. Continuation of hormone replacement therapy is permitted.

• Patients must have a performance status score of 0, 1 or 2 by Eastern Cooperative Group (ECOG) criteria.

• Patients of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of protocol therapy and be practicing an effective form of contraception. If applicable, patients must discontinue breastfeeding prior to study entry.

• Patients must have satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.

• Patients must have signed an IRB-approved informed consent and authorization permitting release of personal health information.

• Patients must be at least 18 years old.

Locations
United States
Alabama
University of Alabama Birmingham
Recruiting
Birmingham
Mitchell Cancer Institute (University of South Alabama)
Recruiting
Mobile
California
University of California - San Diego
Recruiting
La Jolla
Gynecologic Oncology Associates (Hoag Hospital)
Recruiting
Newport Beach
Innovative Clinical Research
Recruiting
Whittier
Florida
The Center for Gynecologic Oncology
Withdrawn
Miramar
Advent Health
Recruiting
Orlando
Women's Care Florida
Recruiting
Saint Petersburg
Massachusetts
Massachusetts General Hospital
Recruiting
Boston
Missouri
Washington University School of Medicine in St. Louis
Recruiting
Saint Louis
Montana
Billings Clinic
Withdrawn
Billings
New Jersey
MD Anderson at Cooper
Recruiting
Camden
Hackensack University Medical Center
Recruiting
Hackensack
New York
Monter Cancer Center
Recruiting
Lake Success
NYU Langone, Long Island
Recruiting
Mineola
NYU Langone
Recruiting
New York
Oklahoma
Stephenson Cancer Center - Oklahoma University
Recruiting
Oklahoma City
Oregon
Providence Cancer Institute
Recruiting
Portland
South Dakota
Sanford Health
Recruiting
Sioux Falls
Tennessee
Chattanooga Women's Health
Recruiting
Chattanooga
The West Clinic
Recruiting
Germantown
Washington
Providence Health Care
Recruiting
Spokane
Wisconsin
Medical College of Wisconsin
Recruiting
Milwaukee
Other Locations
Canada
CHUM
Recruiting
Montréal
Contact Information
Primary
Nicholas Borys, M.D.
nborys@imunon.com
609-896-9100
Time Frame
Start Date: September 5, 2018
Estimated Completion Date: December 31, 2024
Participants
Target number of participants: 130
Treatments
Experimental: NACT + GEN-1
The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles. GEN-1 100 mg/m2 IP will be administered on Days 8 and 15 of the first NACT cycle and then on Days 1, 8, and 15 of the subsequent 21 day NACT cycles for a total of 17 treatments.
Active Comparator: NACT Alone
The NACT regimen will be paclitaxel 175 mg/m2 IV over 3 hours followed by carboplatin AUC 6 IV over 1 hour on Day 1. This will be repeated every 3 weeks for 6 cycles.
Authors
Lindsay Kuroki, David Warshal, Bhavana Pothuri, Mark Reed, Richy Agajanian, Whitney Graybill, Melanie Bergman, Thomas Krivak, Eric Cheung, Alberto Mendivil, Maria Bell, Adam Elnaggar, Jennifer Scalici, Emery Salom, Charles Leath III, Rodney Rocconi, Michael McHale, Megan Indermaur, James Fiorica, Debra Richardson, Robert Holloway, Cara Mathews, Amy Bregar, Veena John, Alexander Olawaiye, Marta Ann Crispens, Camille Gunderson, Susie Lau, Donna McNamara, William Bradley, Justin Bottsford-Miller, Brian Orr, Diane Provencher, Kristopher LyBarger, Stephen DePasquale, Christopher Darus
Related Therapeutic Areas
Sponsors
Leads: Imunon

This content was sourced from clinicaltrials.gov

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