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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

Phase
Phase 2/Phase 3
Sponsor
Global Coalition for Adaptive Research
Enrollment
1,280
Timeline
Jul 2019 → Jun 2030
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Age ≥ 18 years.
  • 2Histologically 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.
  • 3Karnofsky performance status ≥ 60% performed within a 14-day window prior to randomization.
  • 4Availability of tumor tissue representative of GBM from definitive surgery or biopsy.
  • 5Age ≥ 18 years.
  • 6Histologically confirmed Grade IV GBM, inclusive of gliosarcoma (WHO criteria; IDH wild-type by immunohistochemistry \[IHC\] or sequencing for IDH) at first or second recurrence after initial standard, control or experimental therapy that includes at a minimum radiation therapy (RT).
  • 7Evidence of recurrent disease demonstrated by disease progression using slightly modified Response Assessment in Neuro-Oncology (RANO) criteria.
  • 8Two scans to confirm progression are required: at least 1 scan at the time of progression and 1 scan prior to the time of progression.
  • 9Karnofsky performance status ≥ 70% performed within a 14-day window prior to randomization.
  • 10Availability of tumor tissue representative of GBM from initial definitive surgery and/or, recurrent surgery, if performed.

Exclusion Criteria

  • 1Received 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.
  • 2Extensive leptomeningeal disease.
  • 3QTc \> 450 msec if male and QTc \> 470 msec if female.
  • 4History 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.
  • 5Early disease progression prior to 3 months (12 weeks) from the completion of RT.
  • 6More than 2 prior lines for chemotherapy administration. (NOTE: In the 1st line adjuvant setting, combination of temozolomide (TMZ) with an experimental agent, is considered one line of chemotherapy.)
  • 7Received any prior treatment with lomustine, agents part of any of the experimental arms, and bevacizumab or other vascular endothelial growth factor (VEGF) or VEGF receptor-mediated targeted agent.
  • 8Any prior treatment with prolifeprospan 20 with carmustine wafer.
  • 9Any prior treatment with an intracerebral agent.
  • 10Receiving additional, concurrent, active therapy for GBM outside of the trial
  • 11Extensive leptomeningeal disease.
  • 12QTc \> 450 msec if male and QTc \> 470 msec if female.
  • 13History 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.

Locations

62 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Completed

University of Alabama at Birmingham

Birmingham, Alabama 35249

Recruiting

Louis B Nabors, MD

University of California, San Diego

La Jolla, California 92093

Recruiting

David Piccioni, MD, PhD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →