Spots Global Cancer Trial Database for The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma
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Trial Identification
Brief Title: The Toca 5 Trial: Toca 511 & Toca FC Versus Standard of Care in Patients With Recurrent High Grade Glioma
Official Title: A Phase 2/3 Randomized, Open-Label Study of Toca 511, a Retroviral Replicating Vector, Combined With Toca FC Versus Standard of Care in Subjects Undergoing Planned Resection for Recurrent Glioblastoma or Anaplastic Astrocytoma
Study ID: NCT02414165
Study Description
Brief Summary: This is a multicenter, randomized, open-label phase 2/3 study of Toca 511 and Toca FC versus standard of care that comprises Investigator's choice of single agent chemotherapy (lomustine or temozolomide) or bevacizumab administered to subjects undergoing resection for first or second recurrence (including this recurrence) of GBM or AA. Subjects meeting all of the inclusion and none of the exclusion criteria will be randomized prior to surgery in a 1:1 ratio to receive either Toca 511 and Toca FC (Experimental arm, Arm T) or control treatment with one option of standard of care (Arm SOC). Stratification will be done by IDH1 mutation status. A second stratification factor is based on the patient's Karnofsky Performance Score (KPS) (70-80 vs 90-100). Further, to account for potential differences in treatment choices for the control arm in regions, the trial will be stratified by geographical region during the randomization process. Funding Source - FDA OOPD
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Barrow Neurological Institute at Dignity Health St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
University of California, Irvine, Irvine, California, United States
University of California San Diego, La Jolla, California, United States
University of California, Los Angeles, Los Angeles, California, United States
St. Joseph Hospital, Orange, California, United States
University of California San Francisco, San Francisco, California, United States
Stanford University, Stanford, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Colorado Neurological Institute, Englewood, Colorado, United States
Associated Neurologists of Southern Connecticut, Fairfield, Connecticut, United States
Yale University/Yale Cancer Center, New Haven, Connecticut, United States
University of Florida McKnight Brain Institute, Gainesville, Florida, United States
University of Miami, Miami, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
NorthShore University Health System, Evanston, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
University of Michigan, Ann Arbor, Michigan, United States
Henry Ford Health System, Detroit, Michigan, United States
Abbott Northwestern Hospital / Allina Health, Minneapolis, Minnesota, United States
University of Minnesota, Minneapolis, Minnesota, United States
HCA Midwest / Sarah Cannon, Kansas City, Missouri, United States
Washington University St. Louis, Saint Louis, Missouri, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
JFK Medical Center Neuroscience Institute, Edison, New Jersey, United States
John Theurer Cancer Center at Hackensack University, Hackensack, New Jersey, United States
Overlook Medical Center, Summit, New Jersey, United States
North Shore University Hospital, Lake Success, New York, United States
NYU Langone Medical Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
Columbia University, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Stony Brook University Hospital, Stony Brook, New York, United States
Cincinnati's Children's Hospital Medical Center, Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Sanford Research, Sioux Falls, South Dakota, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
Houston Methodist Hospital Outpatient Center, Houston, Texas, United States
University of Texas Health Science Center at Houston (UTHealth), Houston, Texas, United States
University of Virginia Health System, Charlottesville, Virginia, United States
Inova Dwight and Martha Schar Cancer Institute, Fairfax, Virginia, United States
Sentara Neurosurgery Specialists, Norfolk, Virginia, United States
West Virginia University, Morgantown, West Virginia, United States
University of Wisconsin, Madison, Wisconsin, United States
University of Alberta, Edmonton, Alberta, Canada
University of British Columbia / Vancouver General Hospital, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
London Regional Cancer Centre, London, Ontario, Canada
Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario, Canada
Sunnybrook Hospital / Sunnybrook Research Institute, Toronto, Ontario, Canada
Toronto Western Hospital, Toronto, Ontario, Canada
Montreal Neurological Institute, Montreal, Quebec, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Sherbrooke Hospital University Centre (CHUS), Sherbrooke, Quebec, Canada
Rambam Health Care, Haifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Tel Aviv Sourasky Medical Center, Tel-Aviv, , Israel
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Timothy Cloughesy, MD
Affiliation: University of California, Los Angeles
Role: PRINCIPAL_INVESTIGATOR
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