Study Objectives

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 improves patient survival.

More specifically, the purpose of this study is to evaluate the safety of Vigil® Engineered Autologous Tumor Cells (EATCs) as compared to chemotherapy in patients with Ewing’s Sarcoma. In this study, the sponsor and investigators are assessing:

  • safety and efficacy of Vigil® EATCs as compared to chemotherapy, Gemcitabine and Docetaxel
  • how the VIGIL®  EATC immunotherapy and the chemotherapy affect the immune system
 

Who Gets the Vigil® EATCs?

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 or chemotherapy.

Cost to the Patient

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.

How Are The Tumor Cells Modified?

A patient enrolled in this study needs to undergo surgery to remove a piece of their tumor.  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, Ewing’s Sarcoma (Vigil® EATC-EWS).

Dosing

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

 

Why Participate?

Clinical trials involve research to identify the risks and benefits of investigational therapies.  Participation in this study may or may not make your health better, and there may be risks associated with participation.  However, information from this study will help doctors learn more about Vigil® EATC as a potential treatment for cancer, and this information could help future cancer patients.  Patients who participate in this study will be provided medical care during the course of this study, under a physician’s supervision.

Participating In This Clinical Trial

For More Information, Contact
Gladice Wallraven
Tel:  +1-888-582-2282
Email:  clinicaltrials@gradalisinc.com

 

 
Trial Design

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. Trial no. NCT02511132

Tissue Collection Entry Criteria

  • Histologically confirmed Ewing's Sarcoma
  • ≥ 2 years of age
  • Estimated survival ≥ 6 months
  • Evidence of EWS translocation  
  • Metastatic disease
  • Refractory or intolerant to ≥ 2 lines of systemic chemotherapy.
  • Expected availability of a eligible cumulative mass of ~10-30 grams tissue ("golf-ball" size) or pleural fluid estimated volume ≥ 500mL for manufacture of immunotherapy
Tissue Collection Exclusion Criteria

  • Medical condition requiring chronic systemic immunosuppressive therapy (steroid or other)
  • Known history of other malignancy
  • Brain metastases unless treated with curative intent and without evidence of progression for ≥ 2 months.
  • History of autoimmune disease
  • History of allergies or sensitivities to gentamicin
  • Known hypersensitivity to docetaxel

Investigators Enrolling Patients in This Clinical Trials

Investigators Enrolling Patients (Additional sites enrolling in the study will be added soon.  Please contact Gradalis, Inc., to receive information about other sites where study is open.)

Arkansas

Little Rock: Dr. Kathleen Neville, Arkansas Children's Hospital, P: 501-364-4290 E: RedingerCatherineL@uams.edu

California

Los Angeles: Dr. Sant P. Chawla, Sarcoma Oncology, P: 310-552-9999 E: vchua@sarcomaoncology.com  

Florida

Miami: Dr. Guillermo De Angulo, Nicklaus Children's Hospital, P: 786-324-2853 E: coraly.diaz@mch.com

Missouri

St. Louis: Dr. Brian Van Tine, Washington University School of Medicine, P: 314-747-9488 E: landeaum@wustl.edu

New Hampshire

Lebanon: Dr. Sarah Chaffee, Dartmouth-Hitchcock Medical Center, P: 603-650-5021 E: Jo.A.Strohbehn@hitchcock.org 

New York

Bronx: Dr. Jonathan Gill, Children's Hospital at Montefiore, P: 718-741-2342 E:

New York: Dr. Leonard Wexler, Memorial Sloan Kettering Cancer Center, P: 212-639-7990 E: schwamd@mskcc.org

Ohio

Cleveland: Dr. Peter Anderson, Cleveland Clinic Foundation-Children's, P: 216-445-4044 E:  andersp@ccf.org                                                                                                    Cleveland: Dr. Stacey Zahler, Cleveland Clinic Foundation-Children's, P: 216-445-3588 E: zahlers@ccf.org 

Texas

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

Dallas: Dr. Maurizio Ghisoli, Texas Oncology-Medical City, Dallas Pediatric Hematology-Oncology, P:  972-566-3000 E:  referral@marycrowley.org

 


References:

  • Ghisoli MBarve MMennel RLenarsky CHorvath SWallraven GPappen BOWhiting SRao DSenzer NNemunaitis J Three Year Follow up of GMCSF/bi-shRNAfurin DNA Transfected Autologous Tumor Immunotherapy (Vigil™) in Metastatic Advanced Ewing's Sarcoma. Mol Ther. 2016 Apr 25. doi: 10.1038/mt.2016.86. [Epub ahead of print]
  • Senzer N, Barve M, Kuhn J, Melnyk A, Beitsch P, Lazar M, Lifshitz S, Magee M, Oh J, Mill SW, Bedell C, Higgs C, Kumar P, Yu Y, Norvell F, Phalon C, Taquet N, Rao DD, Wang Z, Jay CM, Pappen BO, Wallraven G, Brunicardi FC, Shanahan DM, Maples PB, Nemunaitis J. Phase I trial of "bi-shRNAi(furin)/GMCSF DNA/autologous tumor cell" vaccine (FANG) in advanced cancer. Mol Ther. 2012 Mar;20(3):679-86. doi: 10.1038/mt.2011.269. Epub 2011 Dec 20.
  • Ghisoli M, Barve M, Schneider R, Mennel R, Lenarsky C, Wallraven G, Pappen BO, LaNoue J, Kumar P, Nemunaitis D, Roth A, Nemunaitis J, Whiting S, Senzer N, Fletcher FA, Nemunaitis J. Pilot Trial of FANG Immunotherapy in Ewing's Sarcoma. Mol Ther. 2015 Jun;23(6):1103-9. doi: 10.1038/mt.2015.43. Epub 2015 Mar 19.