92
Participants
Start Date
February 28, 2015
Primary Completion Date
December 31, 2025
Study Completion Date
December 31, 2025
Vigil
The bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Vaccine, Vigil is made up of irradiated autologous tumor cells which have been electroporated ex vivo with the Vigil plasmid designed to suppress expression of both the TGFβ1 and TGFβ2 proteins while simultaneously expressing rhGMCSF protein.
Placebo
"To maintain placebo effect and eliminate bias due to volumetric differences, the number of Vigil doses manufactured from harvested tissue (except if below 4) will be used to guide manufacture of the same number of doses of placebo for each subject. Placebo will consist of freeze media \[10% DMSO (dimethyl sulfoxide; Cryoserv USP; Mylan Institutional USP), 1% Human Serum Albumin (ABO Pharmaceuticals) in Plasma-Lyte A, pH 7.4 (Baxter)\]. Depending upon randomization assignment, placebo or Vigil will be delivered in identical vials and drawn up in 'covered' syringes for intradermal injection."
St. Luke's Health Network, Bethlehem
AMD Asplundh Cancer Pavilion, Abington
Fox Chase Cancer Center, Philadelphia
Duke University Medical Center, Department of Medicine - Oncology, Durham
Prisma Health Cancer Institute, Greenville
Georgia Cancer Center at Augusta University, Augusta
University Of Miami Sylvester Comprehensive Cancer Center, Miami
Florida Cancer Specialists, West Palm Beach
Moffitt Cancer Center, Tampa
University of South Alabama Mitchell Cancer Institute, Mobile
University Of Kentucky Markey Cancer Center, Lexington
Barrett Cancer Center University of Cincinnati Medical Center, Cincinnati
Henry Ford Health System, Detroit
Billings Clinic, Billings
Nebraska Methodist Hospital, Omaha
Stephenson Cancer Center at University of Oklahoma, Oklahoma City
Mary Crowley Cancer Research Centers, Dallas
University of New Mexico Cancer Center, Albuquerque
Southern California Permanente Medical Group, Irvine
Palo Alto Foundation Medical Group, San Francisco
Franciscan Research Center, Tacoma
Cancer Care Northwest, Spokane
Maine Medical Center: MMP Women's Health, Scarborough
Dana Farber Cancer Institute: Gynecologic Oncology, Boston
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center, Lebanon
University of Texas Southwestern Medical Center, Dallas
Lead Sponsor
Gradalis, Inc.
INDUSTRY