Spots Global Cancer Trial Database for A Trial of Vigil for Participants With Ovarian Cancer
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Trial Identification
Brief Title: A Trial of Vigil for Participants With Ovarian Cancer
Official Title: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Vigil Engineered Autologous Tumor Cell Immunotherapy in Subjects With Stage IIIb-IV Ovarian Cancer in Clinical Complete Response Following Surgery and Primary Chemotherapy
Study ID: NCT02346747
Study Description
Brief Summary: The goal of this clinical trial is to compare participants with ovarian, fallopian tube or primary peritoneal cancer when treated with investigational product (Vigil) compared to placebo. The main question it aims to answer is "Will participants who receive treatment with Vigil have a longer time to disease recurrence versus the participants that were not given Vigil?"
Detailed Description: This is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study of maintenance Vigil Ovarian (gemogenovatucel-T) engineered autologous tumor cells (EATC) in women with Stage IIIb, IIIc or IV high-grade papillary serous/ clear cell / endometrioid ovarian, fallopian tube or primary peritoneal cancer. Subjects will have had a minimum of 4 and a maximum of 12 doses of Vigil prepared and stored from ovarian tumor cells obtained at the time of primary surgical debulking or initial diagnostic / evaluative laparoscopy (tissue for immunotherapy manufacture must be procured prior to initiation of neoadjuvant chemotherapy). An equal number of placebo doses will be manufactured. Subjects eligible for randomization will have achieved a clinically defined complete response following primary surgery and adjuvant chemotherapy. Clinical complete response (cCR) is defined as no evidence of maligancy on chest x-ray and CT scan or MRI of the abdomen and pelvis, CA-125 antigen level ≤ units/mL, and no findings on physical examination or symptoms suggestive of active cancer. Investigational treatment must start no less than 3 weeks and no more than 8 weeks following completion of chemotherapy. Approximately 86 subjects will be randomized 1:1 to to Group A (Vigil 1.0 X 10e7 cells/injection) or Group B (placebo). Randomization will be stratified by (i) extent of surgical cytoreduction (complete/microscopic versus macroscopic residual disease) and (ii) neoadjuvant versus adjuvant chemotherapy. Participants will receive Vigil or placebo by intradermal injection once a month for at least 4 and up to a maximum of 6 doses determined by the number of doses of Vigil manufactured for that subject. Participants will be managed in an outpatient setting. Image assessment with chest x-ray and CT scan or MRI of the abdomen and pelvis will be completed every 3 months in Years 1-3, then every 6 months in Years 4 and 5 and yearly through Year 10. At the time the participant recurs, the participant will enter long term follow-up for survival status and post treatment therapies received.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
University of South Alabama Mitchell Cancer Institute, Mobile, Alabama, United States
Southern California Permanente Medical Group, Irvine, California, United States
Palo Alto Foundation Medical Group, San Francisco, California, United States
University Of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Florida Cancer Specialists, West Palm Beach, Florida, United States
Georgia Cancer Center at Augusta University, Augusta, Georgia, United States
University Of Kentucky Markey Cancer Center, Lexington, Kentucky, United States
Maine Medical Center: MMP Women's Health, Scarborough, Maine, United States
Dana Farber Cancer Institute: Gynecologic Oncology, Boston, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Billings Clinic, Billings, Montana, United States
Nebraska Methodist Hospital, Omaha, Nebraska, United States
Dartmouth-Hitchcock Medical Center/Norris Cotton Cancer Center, Lebanon, New Hampshire, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Duke University Medical Center, Department of Medicine - Oncology, Durham, North Carolina, United States
Barrett Cancer Center University of Cincinnati Medical Center, Cincinnati, Ohio, United States
Stephenson Cancer Center at University of Oklahoma, Oklahoma City, Oklahoma, United States
AMD Asplundh Cancer Pavilion, Abington, Pennsylvania, United States
St. Luke's Health Network, Bethlehem, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Prisma Health Cancer Institute, Greenville, South Carolina, United States
Mary Crowley Cancer Research Centers, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Cancer Care Northwest, Spokane, Washington, United States
Franciscan Research Center, Tacoma, Washington, United States
Contact Details
Name: John Nemunaitis, MD
Affiliation: Gradalis, Inc.
Role: STUDY_DIRECTOR
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