This clinical trial is designed to evaluate whether a tumor cell that is engineered to make it more recognizable by our body’s immune system, can generate an immune response from our body such that it keeps the cancer in check and improve patients survival.  Patients who wish to participate in this clinical trial need to meet both Tissue Collection, and Study Entry Inclusion and Exclusion Criteria.  This is not an exhaustive list.  Additional details about the criteria may be found on the clinicaltrials.gov website. NCT 02346747

In this study, the sponsor and investigators are assessing:  

  • the effect on recurrence of cancer after receiving VIGIL® Engineered Autologous Tumor Cells (EATCs) as compared to placebo
  • the patient's ability to do everyday tasks and activities after receiving VIGIL® EATCs as compared to placebo.

How Are The Tumor Cells Modified? 

When an ovarian cancer patient is enrolled in this study, a piece of their tumor is removed during 'debulking' surgery.  This tumor is shipped to Gradalis, Inc.'s manufacturing facility, where cells derived from the tumor are genetically modified using Vigil® technology, to make them more recognizable to the patient’s immune system.  After steps of transforming and irradiation, the tumor cells are then called Vigil Engineered Autologous Tumor Cells, Ovarian Cancer (Vigil® EATC-OC).

 

Trial Design

Who Gets Vigil®

This clinical trial is a 1:1 randomized clinical trial, with two arms, the test arm, Arm A, and the “control” arm, Arm B.  Each patient that is enrolled in the clinical trial is randomly assigned to either Arm A or Arm B.  “1:1 randomization” means that each patient has an equal chance of receiving either Vigil® EATC-OC or placebo.

Dosing

These Vigil® EATC-OC, standardized to a dose of 10 million cells per milliliter, are frozen and shipped to the clinical trial site, where the dose is administered to the patient.

Tissue Collection Exclusion Criteria
Tissue Collection Inclusion Criteria
  • Histologically confirmed papillary serous adenocarcinoma
  • Medical condition requiring chronic systemic immunosuppressive therapy (steroid or other)
  • Prior splenectomy
  • Congestive heart failure, unstable angina, atrial arrhythmia, or cardiovascular disease (current or within the past 6 months)
  • History of brain metastases
  • Known HIV or chronic Hepatitis B or C infection
  • Prior solid organ or bone marrow transplant
  • History of active autoimmune disease
  • Presumptive Stage III/IV high-grade serous/endometrioid ovarian, fallopian tube or primary peritoneal cancer
  • No chemotherapy or investigational agents prior to tissue acquisition for Vigil™ manufacture
  • 18 yrs of age or older
  • No other malignancy
  • ECOG performance status 0-2
  • Expected availability of a eligible cumulative mass of ~10-30 grams tissue (cumulative "golf-ball" size mass) for manufacture of immunotherapy

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Cost to Patients

Subjects will not be charged for participating in this clinical trial. Subjects will discuss any other costs associated with the clinical trial with their physician.

Investigators Enrolling Patients In the Study

(Site information will be updated as soon as permissions are received.  Meanwhile, please contact Gradalis, Inc., directly through our Contacts page to receive information about those sites).

California

Irvine: Dr. Devansu Tewari, Southern California Permanente Group, P: 949-932-5695 E: patricia.x.wride@kp.org

Florida

Miami: Dr. Brian Slomovitz, Sylvester Comprehensive Cancer Center, P: 305-243-1000 E: bslomovitz@med.miami.edu

Tampa: Dr. Robert Wenham, Moffitt Cancer Center, P: 813-745-7272 E: denise.dorman@moffitt.org

West Palm Beach: Dr. Howard M Goodman, Florida Cancer Specialist, P: 561-472-1696 E: jbar-nur@flcancer.com

Georgia

Augusta: Dr. Sharad A Ghamande, Georgia Cancer Center, P: 706-721-5557 E: chprice@gru.edu

Kentucky

Lexington: Dr. Fred Ueland, Markey Cancer Center, P: 859-257-3379 E: patricia.levitt@uky.edu

Massachusetts

Boston: Dr. Neil S. Horowitz, Dana Farber Cancer Institute, P: 617-582-7738 E: cwhalen@partners.org

Michigan

Detroit: Dr. Adnan Munkarah, Henry Ford Health System, P: 402-354-7939 E: kathryn.bartz@nmhs.org

Montana

Billings: Dr. Erin Stevens, Billings Clinic, P: 406-435-7415 E: kwilkinson@billingsclinic.org

Nebraska

Omaha: Dr. Peter C. Morris, Nebraska Methodist Hospital, P: 402-354-7939 E: kathryn.bartz@nmhs.org  

New Mexico

Albuquerque: Dr. Sarah F. Adams, UNM Comprehensive Cancer Center, P: 505-925-0387 E: CGan@salud.unm.edu

North Carolina

Durham: Dr. Stephanie L. Gaillard, Duke Cancer Institute, P: 919-684-3780 E: jennifer.mewshaw@duke.edu

Pennsylvania

Abington: Dr. Parviz Hanjani, Abington Memorial Hospital, P: 215-885-0220 E: phanjani@abingtonhealth.org  

Bethlehem: Dr. Israel Zighelboim, St. Luke's University Health Network, P: 484-526-5190 E: Tracy.Butryn@sluhn.org   

South Carolina

Greenville: Dr. Jeffery Elder, Greenville Hospital System Cancer Institute, P: 864-241-6251 E: gnorris@ghs.org  

Texas

Dallas: Dr. Lea Jayanthi, UTSouthwestern Medical Center, P: 214-648-7094   E: Tiffany.thomas@utsouthwestern.edu

Dallas: Dr. Minal Barve, Mary Crowley Cancer Research Center, P: 972-566-3000 E: referral@marycrowley.org

Washington

Spokane: Dr. Elizabeth Grosen, Cancer Care NorthWest, P: 509-228-1689 E: Rose.Miller@ccnw.net

Tacoma: Dr. Bahman Saffari, CHI Franciscan Research Center, P: 253-426-6882 E: conchitapurchase@chifranciscan.org