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High Grade Glioma clinical trials

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NCT ID: NCT06357377 Not yet recruiting - High Grade Glioma Clinical Trials

A Study of the Safety, Dosing, and Delivery of NEO100 in Patients With Pediatric Brain Tumors

Start date: May 1, 2024
Phase: Phase 1
Study type: Interventional

This is an open label, Phase 1b safety, dose-finding, brain tumor delivery, and pharmacokinetics study of intranasal NEO100 in patients with pediatric-type diffuse high grade gliomas. Patients will receive IN NEO100 that will follow a dose titration design, followed by a standard dose escalation design to establish safety. Brain tumor delivery of NEO100 will be confirmed in each disease sub-type by surgical resection/needle biopsy only if clinically indicated and scheduled for clinical purposes and testing with residual tissue for NEO100 and the major metabolite of NEO100 (Perillic Acid).

NCT ID: NCT06333899 Not yet recruiting - Glioblastoma Clinical Trials

Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

Start date: September 1, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.

NCT ID: NCT06201351 Not yet recruiting - High-grade Glioma Clinical Trials

Study of Adaptive Radiotherapy for High-grade Glioma Based on Interfraction MRI

Start date: January 1, 2024
Phase:
Study type: Observational

The changes of target and organs at risk in patients with high-grade glioma during concurrent chemoradiotherapy were evaluated by MRI image between radiotherapy fractions.

NCT ID: NCT06161974 Not yet recruiting - High Grade Glioma Clinical Trials

Study of Olutasidenib and Temozolomide in HGG

Start date: June 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to determine the efficacy of the study drug olutasidenib to treat newly diagnosed pediatric and young adult patients with a high-grade glioma (HGG) harboring an IDH1 mutation. The main question the study aims to answer is whether the combination of olutasidenib and temozolomide (TMZ) can prolong the life of patients diagnosed with an IDH-mutant HGG.

NCT ID: NCT06002711 Not yet recruiting - High-grade Glioma Clinical Trials

Multi-Dimensional MRI Spatial Heterogeneity Analysis for Predicting Key Genes and Prognosis of High-Grade Gliomas: A Multi-Center Study

Start date: September 1, 2023
Phase:
Study type: Observational

1. To retrospectively explore the feasibility of multi-dimensional heterogeneity imaging features of MRI in predicting the status of key gene mutations in high-grade gliomas; 2. To prospectively explore the correlation between multi-dimensional heterogeneous MRI image features and prognosis of high-grade glioma patients.

NCT ID: NCT05850377 Not yet recruiting - Glioma Clinical Trials

5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas

Start date: June 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to evaluate disease-free survival (DFS) in patients with malignant gliomas undergoing neurosurgical procedures using 5-aminolevulinic acid (5-ALA)-based photodynamic therapy

NCT ID: NCT05843253 Not yet recruiting - Glioblastoma Clinical Trials

Study of Ribociclib and Everolimus in HGG and DIPG

Start date: May 30, 2024
Phase: Phase 2
Study type: Interventional

The goal of this study is to determine the efficacy of the study drugs ribociclib and everolimus to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (cell cycle, PI3K/mTOR) that these drugs target. The main question the study aims to answer is whether the combination of ribociclib and everolimus can prolong the life of patients diagnosed with HGG, including DIPG.

NCT ID: NCT05839379 Not yet recruiting - Glioblastoma Clinical Trials

Targeted Pediatric High-Grade Glioma Therapy

Start date: May 30, 2024
Phase:
Study type: Observational

The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.

NCT ID: NCT05632562 Not yet recruiting - High Grade Glioma Clinical Trials

Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma

Start date: June 1, 2025
Phase: Early Phase 1
Study type: Interventional

This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography/magnetic resonance imaging (PET/MRI) with O-([2-[F-18]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-[F-18]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET/MRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET/MRI studies.

NCT ID: NCT05096481 Not yet recruiting - High Grade Glioma Clinical Trials

PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma

Start date: April 15, 2024
Phase: Phase 2
Study type: Interventional

This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51. Funding Source - FDA OOPD