Glioblastoma, IDH-Wildtype Clinical Trial
Official title:
Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)
Verified date | January 2024 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. The usual approach for this currently is magnetic resonance imaging (MRI). This study is trying to learn more about the meaning of changes in MRI scans after treatment, as while the appearance of some of these changes may reflect progressing tumor, some may be due the treatment. Dynamic susceptibility contrast (DSC)-MRIs, along with positron emission tomography (PET) and/or magnetic resonance (MR) spectroscopy, may help doctors tell which changes are a reflection of the treatment and which changes may be due to progressing tumor.
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | May 31, 2027 |
Est. primary completion date | May 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient must be = 18 years of age. - Patient must have a Karnofsky Performance Status = 60%. - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
ECOG-ACRIN Cancer Research Group |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival (OS) | Will use a two-sided log-rank test to compare the difference in OS between marker positive and marker negative participants using a significance level of 0.05. | From biomarker collection to death due to any cause, assessed up to 6 years | |
Primary | Event free survival (EFS) | NANO progression is defined as a = 2 level worsening from baseline or best level of function in at least one domain or worsening to the highest score within =1 domain that is felt to be related to underlying tumor progression and not attributable to a comorbid event or change in concurrent medication. Will be based on the conditional power of a two-sided log-rank test for EFS between marker positive and marker negative participants using a significance level of 0.05. | From biomarker collection until progression by Neurological Assessment in Neuro-Oncology (NANO) criteria or death, assessed up to 6 years | |
Secondary | True disease progression and pseudo-progression (PsP) | The T3 MRI will be used to determine whether progressive enhancement seen within 12 weeks post-XRT was true progression or PsP. | Within 12 weeks post radiation therapy (XRT) | |
Secondary | Progression-free survival (PFS) | From surgery to the earlier of progression or death due to any cause, assessed up to 6 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05941234 -
Stem Cell Analysis, Omics (Including Immunomics) and Artificial Intelligence in Glioblastoma
|
N/A | |
Recruiting |
NCT04528680 -
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT06160596 -
Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis
|
||
Recruiting |
NCT06047379 -
Safety and Efficacy of NEO212 in Patients With Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype or Brain Metastasis
|
Phase 1/Phase 2 | |
Recruiting |
NCT05879250 -
WP1066 and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma
|
Phase 2 | |
Not yet recruiting |
NCT04945148 -
Oxidative Phosphorylation Targeting In Malignant Glioma Using Metformin Plus Radiotherapy Temozolomide
|
Phase 2 | |
Not yet recruiting |
NCT05842746 -
Elemene Plus Stupp Protocol Versus Stupp Protocol Alone for Newly-diagnosed Glioblastoma
|
Phase 2 | |
Not yet recruiting |
NCT06419946 -
Lomustine in Addition to Standard of Care in Patients With MGMT Methylated Glioblastoma
|
Phase 3 | |
Completed |
NCT03434262 -
SJDAWN: St. Jude Children's Research Hospital Phase 1 Study Evaluating Molecularly-Driven Doublet Therapies for Children and Young Adults With Recurrent Brain Tumors
|
Phase 1 | |
Recruiting |
NCT06418113 -
Neoadjuvant Radio-chemotherapy Safety Pilot Study in Patients With Glioblastoma
|
Phase 1 | |
Recruiting |
NCT05326334 -
THERApeutic Outcomes Related to Gut microBIOME in Glioblastoma (GBM) Patients Receiving Chemo-radiation (THERABIOME-GBM)
|
||
Recruiting |
NCT05375318 -
BIOhabitats: Biological Validation of Vascular Habitats Within Astrocytoma Grade 4 at Molecular, Cellular, and Histopathological Levels
|
||
Not yet recruiting |
NCT06359379 -
Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter
|
Phase 2 | |
Recruiting |
NCT06095375 -
Regorafenib With Temozolomide With or Without RT in MGMT-Methylated, IDH Wild-type GBM Patients
|
Phase 1 | |
Recruiting |
NCT05879367 -
Evaluation of Eflornithine Plus Temozolomide in Patients With Newly Diagnosed Glioblastoma
|
Phase 1 | |
Recruiting |
NCT05759195 -
Biomolecular Analysis for Predicting Response to Regorafenib
|
N/A | |
Recruiting |
NCT06146738 -
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
|
||
Recruiting |
NCT06283927 -
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
|
||
Recruiting |
NCT06273176 -
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
|
||
Recruiting |
NCT06146725 -
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
|