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

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ClinicalTrials.gov Identifier: NCT03393884
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Celsion

Brief 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.

Condition or disease Intervention/treatment Phase
Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer Biological: GEN-1 Drug: Carboplatin Drug: Paclitaxel Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : October 31, 2023


Arm Intervention/treatment
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.
Biological: GEN-1
IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer

Drug: Carboplatin
AUC 6 IV over 1 hour on Day 1 of each cycle

Drug: Paclitaxel
175 mg/m2 IV over 3 hours on Day 1 of each cycle

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.
Drug: Carboplatin
AUC 6 IV over 1 hour on Day 1 of each cycle

Drug: Paclitaxel
175 mg/m2 IV over 3 hours on Day 1 of each cycle




Primary Outcome Measures :
  1. PFS [ Time Frame: The primary analysis for PFS will be conducted after at least 52 events have been observed or after all patients have been followed for at least 12 months, whichever is later. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393884


Contacts
Contact: Nicholas Borys, M.D. 609-896-9100 nborys@celsion.com
Contact: Lauren Musso 609-896-9100 lmusso@celsion.com

Locations
United States, Alabama
University of Alabama Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Anna Wilbanks         
Principal Investigator: Charles Leath III, MD         
Mitchell Cancer Institute (University of South Alabama) Recruiting
Mobile, Alabama, United States, 36604
Contact: Tammy Mitchem-Welch, BSN, RN    251-445-9649    twelch@health.southalabama.edu   
Principal Investigator: Rodney Rocconi, MD         
United States, Missouri
Washington University School of Medicine in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Lynne Lippmann, CCRP    314-362-1760    lippmannl@wustl.edu   
Principal Investigator: Lindsay Kuroki, MD         
United States, Oklahoma
Stephenson Cancer Center - Oklahoma University Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Kristie Sheen         
Principal Investigator: Camille Gunderson, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Brenda Steele         
Principal Investigator: Alexander Olawaiye, MD         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Not yet recruiting
Nashville, Tennessee, United States, 37203
Contact: Anna Dumont         
Principal Investigator: Marta Ann Crispens, MD         
United States, Wisconsin
Medical College of Wisconsin Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Sukanya Skandarajah         
Principal Investigator: William Bradley, MD         
Sponsors and Collaborators
Celsion
Investigators
Study Chair: Premal H. Thaker, M.D Washington University School of Medicine

Responsible Party: Celsion
ClinicalTrials.gov Identifier: NCT03393884     History of Changes
Other Study ID Numbers: 201-17-201
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action