Clinical Trial 23404

• Overview

  Study Title:

  Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)

  Summary:

  This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma.

  Objective:

  Primary Objective * For each biomarker (Dynamic Susceptibility Contrast-Enhanced MR Imaging, 18F-fluciclovine PET, MR Spectroscopy), to evaluate whether the biomarker can stratify patients with newly diagnosed GBM that have progressive enhancement within 12 weeks post-XRT into risk groups based on overall survival. Secondary Objectives * To evaluate whether each biomarker (Dynamic Susceptibility Contrast-Enhanced MR Imaging, 18F-fluciclovine PET, MR Spectroscopy) can predict final determination of PsP vs. true progression on follow-up MR imaging as evaluated by a semi-automated central reading process and by institutional radiologist readings. * To evaluate whether a prediction model that incorporates multiple biomarkers can discriminate patients with progressive enhancement within 12 weeks post-XRT into high and low risk groups for overall survival. * To evaluate whether clinical and imaging biomarkers are predictive of overall and progression-free survival in patients who do not show progressive enhancement within 12 weeks post-XRT.

• Treatments

  Therapies:

  Chemotherapy (NOS); Radiotherapy

  Medications:

  Radiotherapy (); Temodal (Temozolomide); Temozolomide ()

• Inclusion Criteria

  Inclusion Criteria:
  • Patient must be 18 years of age or older.
  • Patient must have a Karnofsky Performance Status 60% or greater.
  • Patient must have newly diagnosed GBM (must be IDH wild type), with pathologic proof, based on World Health Organization (WHO) 2021 criteria.
  • Patient must be planning to receive standard-of-care treatment for newly diagnosed glioblastoma.
  • Patient must have completed an MRI prior to the diagnostic surgery for GBM and have images available for upload into Transfer of Images and Data (TRIAD).
  • Patient must have diagnostic surgery for GBM within 7 weeks prior to registration.
  • Patient must have O6-Methylguanine-DNA Methyltransferase (MGMT) methylation status ordered at time of registration.
  • Patient must have a post-operative (op) MRI completed within 3 weeks after diagnostic surgery for GBM and have images available for upload into TRIAD.
  • Patient must have no contraindications to MRI, including injection of gadolinium-based contrast agents, and demonstrated ability to tolerate MRI on pre-surgical imaging.
  • Patient must have no allergies to agents that may potentially be used for non-standard of care imaging (18F-fluciclovine, MR contrast).
  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the interventions being used.
  • All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

• Exclusion Criteria

  Exclusion Criteria:
  • Patients not meeting all Inclusion Criteria will not be considered for this Clinical Trial

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