RWF_201-17-201 Ovation 2

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

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.

Inclusion Criteria:
• 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, Renal function, Hepatic function, Neurologic function
• 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 satisfactory results for the baseline laboratory analyses and diagnostic procedures as specified in the protocol.

Exclusion Criteria:
• Patients who have received prior treatment with GEN-1.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to GEN-1 or other agents used in this study.
• 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.
• Patients receiving treatment for active autoimmune disease. Active refers to any condition currently requiring therapy.
• Patients with other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in the protocol are excluded if there is any evidence of other malignancy being present within the last three years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
• Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
• Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients may have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
• Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
• Patients with history or evidence upon physical examination of CNS disease within six months of the first date of treatment on this study.
• Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration
Phase I/II
Christopher Darus, M.D.
Nora Auston
  • Providence Cancer Institute Franz Clinic