RECRUITING

A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

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Conditions

GlioblastomaNewly diagnosedrecurrentO6-methylguanine-DNA-methyltransferase (MGMT) methylatedMGMT unmethylatedisocitrate dehydrogenase (IDH) wild-typeBayesianadaptive randomizationMaster ProtocolPlatform TrialPhase 2Phase 3

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

Official Title

GBM AGILE: Global Adaptive Trial Master Protocol: an International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent GBM

Quick Facts

Study Start:2019-07-30
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03970447

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years.
  2. * Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \[IHC\] or sequencing for IDH) established following either a surgical resection or biopsy. An MRI scan with the required imaging sequences performed within 21 days prior to randomization preferably. The post-operative MRI scan performed within 96 hours of surgery or the MRI scan performed for radiation therapy planning may serve as the MRI scan performed during screening if all required imaging sequences were obtained.
  3. * Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.
  4. * Availability of tumor tissue representative of GBM from definitive surgery or biopsy.
  1. * Received any prior treatment for glioma including: a. Prior prolifeprospan 20 with carmustine wafer. b. Prior intracerebral, intratumoral, or cerebral spinal fluid (CSF) agent. c. Prior radiation treatment for GBM or lower-grade glioma. d. Prior chemotherapy or immunotherapy for GBM or lower-grade glioma. Receiving additional, concurrent, active therapy for GBM outside of the trial.
  2. * Extensive leptomeningeal disease.
  3. * QTc \> 450 msec if male and QTc \> 470 msec if female.
  4. * History of another malignancy in the previous 2 years, with a disease-free interval of \< 2 years. Patients with prior history of in situ cancer or basal or squamous cell skin cancer are eligible.

Contacts and Locations

Study Contact

Patient Information
CONTACT
310-598-3199
patientinfo@gcaresearch.org
Rachel Rosenstein-Sisson
CONTACT
RRosenstein.Sisson@GCAResearch.org

Principal Investigator

Tim Cloughesy, MD
PRINCIPAL_INVESTIGATOR
GCAR CMO and GBM AGILE Global PI

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35249
United States
University of California, San Diego
La Jolla, California, 92093
United States
Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
United States
University of California, Los Angeles
Los Angeles, California, 90095
United States
St. Joseph Hospital
Orange, California, 92868
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Stanford Cancer Center
Stanford, California, 94305
United States
University of Colorado Denver
Aurora, Colorado, 80045
United States
Yale Cancer Center / Smilow Cancer Hospital
New Haven, Connecticut, 06511
United States
Mayo Clinic Cancer Center
Jacksonville, Florida, 32224
United States
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Piedmont Atlanta Hospital
Atlanta, Georgia, 30309
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
United States
LSU Health Sciences Center - New Orleans
New Orleans, Louisiana, 70112
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Mayo Clinic Cancer Center - Rochester
Rochester, Minnesota, 55905
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39213
United States
Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri, 63110
United States
Perlmutter Cancer Center, NYU Langone Health
New York, New York, 10016
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Duke University Medical Center
Durham, North Carolina, 27710
United States
Comprehensive Cancer Center of Wake Forest
Winston-Salem, North Carolina, 272157
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Ohio State University Cancer Center
Columbus, Ohio, 43210
United States
University of Pennsylvania - Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
United States
University of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
Medical University of South Carolina - Hollings Cancer Center
Charleston, South Carolina, 29425
United States
Texas Oncology - Austin
Austin, Texas, 78705
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
University of Virginia Health
Charlottesville, Virginia, 22908
United States
University of Washington Medical Center
Seattle, Washington, 98101
United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Global Coalition for Adaptive Research

  • Tim Cloughesy, MD, PRINCIPAL_INVESTIGATOR, GCAR CMO and GBM AGILE Global PI

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-07-30
Study Completion Date2028-06

Study Record Updates

Study Start Date2019-07-30
Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

  • Glioblastoma
  • Newly diagnosed
  • recurrent
  • O6-methylguanine-DNA-methyltransferase (MGMT) methylated
  • MGMT unmethylated
  • isocitrate dehydrogenase (IDH) wild-type
  • Bayesian
  • adaptive randomization
  • Master Protocol
  • Platform Trial
  • Phase 2
  • Phase 3

Additional Relevant MeSH Terms

  • Glioblastoma