Clinical Trials /

Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2)

NCT03393884

Description:

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.

Related Conditions:
  • Fallopian Tube Adenocarcinoma
  • Fallopian Tube Endometrioid Adenocarcinoma
  • Fallopian Tube Undifferentiated Carcinoma
  • High Grade Fallopian Tube Serous Adenocarcinoma
  • High Grade Ovarian Serous Adenocarcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Tumor
  • Ovarian Undifferentiated Carcinoma
  • Primary Peritoneal Endometrioid Adenocarcinoma
  • Primary Peritoneal Serous Adenocarcinoma
  • Primary Peritoneal Undifferentiated Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of GEN-1 With NACT for Treatment of Ovarian Cancer (OVATION 2)
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: 201-17-201
  • NCT ID: NCT03393884

Conditions

  • Epithelial Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer

Interventions

DrugSynonymsArms
GEN-1NACT + GEN-1
CarboplatinNACT + GEN-1
PaclitaxelNACT + GEN-1

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
NACT + GEN-1ExperimentalThe 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.
  • GEN-1
  • Carboplatin
  • Paclitaxel
NACT AloneActive ComparatorThe 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.
  • Carboplatin
  • Paclitaxel

Eligibility Criteria

        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) 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.).

          4. Patients must have adequate:

               1. 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.

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

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

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

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

          6. 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.

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

          8. 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.

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

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

         11. Patients must be at least 18 years old.

        Exclusion Criteria:

          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. "Active" refers to any
             condition currently requiring therapy. Examples of autoimmune disease include systemic
             lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid
             arthritis.

          5. 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.

          6. 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.

          7. 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.

          8. Patients with known active hepatitis.

          9. 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.

         10. Patients of childbearing potential, not practicing adequate contraception, patients
             who are pregnant, or patients who are breastfeeding are not eligible for this trial.

         11. Patients with history or evidence upon physical examination of CNS disease, including
             primary brain tumor, seizures not controlled with standard medical therapy, any brain
             metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic
             attack (TIA) or subarachnoid hemorrhage within six months of the first date of
             treatment on this study.

         12. Patients with any condition/anomaly that would interfere with the appropriate
             placement of the IP catheter for study drug administration including: abdominal
             surgery within 4 weeks of study entry (for reasons other than IP port placement),
             intestinal dysfunction, or suspected extensive adhesions from prior history or finding
             at laparoscopy.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:PFS
Time Frame:The primary analysis for PFS will be conducted after at least 80 events have been observed or after all patients have been followed for at least 16 months, whichever is later.
Safety Issue:
Description:The primary objective of the study is to evaluate safety and compare progression free survival between subjects receiving neoadjuvant chemotherapy (NACT) plus GEN-1 versus standard NACT.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Celsion

Last Updated

November 12, 2019