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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Ovarian Cancer
  • Age: Between 18 - 100 Years
  • Gender: Female
  • Other Inclusion Criteria:
    1) Patients must have 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. 2) Patients must have an International Federation of Gynecology and Obstetrics (FIGO) stage of III or IV. 3) 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.).

You may not be eligible for this study if the following are true:

  • 1) Patients who have received prior treatment with GEN-1. 2) History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study. 3) Patients who have received oral or parenteral corticosteroids within 2 weeks of study entry or who have a clinical requirement for ongoing systemic immunosuppressive therapy such as chronic steroid use not related to chemotherapy administration. 4) Patients receiving treatment for active autoimmune disease.


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