Ovarian Cancer Clinical Trial

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

View Eligibility Criteria

Eligibility Criteria

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: 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.

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. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
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 known active hepatitis.
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 of childbearing potential, not practicing adequate contraception, patients who are pregnant, or patients who are breastfeeding are not eligible for this trial.
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.
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.

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT03393884

Recruitment Status:

Recruiting

Sponsor:

Imunon

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 24 Locations for this study

See Locations Near You

University of Alabama Birmingham
Birmingham Alabama, 35233, United States More Info
Anna Wilbanks
Contact
[email protected]
Charles Leath III, MD
Principal Investigator
Mitchell Cancer Institute (University of South Alabama)
Mobile Alabama, 36604, United States More Info
Joanie Broemmelsiek, BSN, RN
Contact
[email protected]
Jennifer Scalici, MD
Principal Investigator
University of California - San Diego
La Jolla California, 92093, United States More Info
Mandy Natsuhara
Contact
[email protected]
Michael McHale, MD
Principal Investigator
Gynecologic Oncology Associates (Hoag Hospital)
Newport Beach California, 92663, United States More Info
Ana Navarrete
Contact
[email protected]
Alberto Mendivil, MD
Principal Investigator
Innovative Clinical Research
Whittier California, 90603, United States More Info
Kirsten Bettino
Contact
[email protected]
Richy Agajanian, MD
Principal Investigator
The Center for Gynecologic Oncology
Miramar Florida, 33027, United States
Advent Health
Orlando Florida, 32803, United States More Info
Alejandra Ricaurte
Contact
[email protected]
Robert Holloway, MD
Principal Investigator
Women's Care Florida
Saint Petersburg Florida, 33701, United States More Info
Penny Thompson
Contact
[email protected]
Megan Indermaur, MD
Principal Investigator
Massachusetts General Hospital
Boston Massachusetts, 02114, United States More Info
Lauren Skinnion
Contact
[email protected]
Amy Bregar, MD
Principal Investigator
Washington University School of Medicine in St. Louis
Saint Louis Missouri, 63110, United States More Info
Sarah Drake
Contact
[email protected]
Lindsay Kuroki, MD
Principal Investigator
Billings Clinic
Billings Montana, 59101, United States
MD Anderson at Cooper
Camden New Jersey, 08105, United States More Info
Annette Foti
Contact
[email protected]
David Warshal, MD
Principal Investigator
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States More Info
Aretha DiSalvo
Contact
[email protected]
Donna McNamara, MD
Principal Investigator
Monter Cancer Center
Lake Success New York, 11042, United States More Info
Mary Agnes Templeton
Contact
[email protected]
Veena John, MD
Principal Investigator
NYU Langone, Long Island
Mineola New York, 11501, United States More Info
Jennifer Himmel
Contact
[email protected]
Bhavana Pothuri, MD
Principal Investigator
NYU Langone
New York New York, 10016, United States More Info
Kathryn Allen
Contact
[email protected]
Bhavana Pothuri, MD
Principal Investigator
Stephenson Cancer Center - Oklahoma University
Oklahoma City Oklahoma, 73104, United States More Info
Kortni Gentry
Contact
[email protected]
Debra Richardson, MD
Principal Investigator
Providence Cancer Institute
Portland Oregon, 97213, United States More Info
Nora Auston
Contact
[email protected]
Christopher Darus, M.D.
Principal Investigator
Sanford Health
Sioux Falls South Dakota, 57104, United States More Info
Ashley Johnson
Contact
[email protected]
Maria Bell, MD
Principal Investigator
Chattanooga Women's Health
Chattanooga Tennessee, 37403, United States More Info
Kim Donelson
Contact
[email protected]
Stephen DePasquale, MD
Principal Investigator
The West Clinic
Germantown Tennessee, 38138, United States More Info
Madison Smith
Contact
[email protected]
Mark Reed, MD
Principal Investigator
Providence Health Care
Spokane Washington, 99204, United States More Info
Sherry Loubardias-Fassler
Contact
[email protected]
Melanie Bergman, M.D.
Principal Investigator
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Qiana Christian
Contact
[email protected]
William Bradley, MD
Principal Investigator
CHUM
Montréal , H2X 0, Canada More Info
Adeline Hamon
Contact
[email protected]
Diane Provencher, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

130

Study ID:

NCT03393884

Recruitment Status:

Recruiting

Sponsor:


Imunon

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.