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Glioma clinical trials

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NCT ID: NCT04775485 Recruiting - Clinical trials for Advanced Solid Tumor

A Study to Evaluate DAY101 in Pediatric and Young Adult Patients With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors

FIREFLY-1
Start date: April 22, 2021
Phase: Phase 2
Study type: Interventional

FIREFLY-1 is an ongoing, Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known RAF alteration.

NCT ID: NCT04772456 Recruiting - Glioma Clinical Trials

Hyperpolarized 13C-pyruvate Metabolic MRI With Infiltrating Gliomas

Start date: August 11, 2020
Phase: Phase 1
Study type: Interventional

The purpose of this study is to examine the safety and feasibility of performing hyperpolarized metabolic MRI in the diagnosis of brain tumor. This study will also assess the accuracy of hyperpolarized metabolic MRI to diagnose intermediate to patients with infiltrating gliomas and examine the added utility of metabolic MRI over standard MRI imaging The FDA is allowing the use of hyperpolarized [1-13C] pyruvate (HP 13C-pyruvate) in this study. Up to 5 patients may take part in this study at the University of Maryland, Baltimore (UMB).

NCT ID: NCT04771897 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

A Study of BXQ-350 in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) or Diffuse Midline Glioma (DMG)

KONQUER
Start date: May 24, 2021
Phase: Phase 1
Study type: Interventional

This study will evaluate the safety of BXQ-350 and determine the maximum tolerated dose (MTD) in children with newly diagnosed DIPG or DMG. All patients will receive BXQ-350 by intravenous (IV) infusion and radiation therapy. The study is divided into two parts: Part 1 will enroll patients at increasing dose levels of BXQ-350 in order to determine the MTD. Part 2 will enroll patients requiring a biopsy in order to assess BXQ-350 concentrations in the biopsied tumor.

NCT ID: NCT04771806 Recruiting - Malignant Glioma Clinical Trials

Serial Advanced Magnetic Resonance Imaging Scan for Guidance of Personalized Adaptive Radiotherapy for High Grade Glioma

Start date: April 1, 2019
Phase:
Study type: Observational

This study examines whether repeated magnetic resonance imaging (MRI)s scan helps identify changes in the tumor during radiation and chemotherapy treatment in patients with high grade glioma. Additional MRIs scan may help researchers to see changes in the status of the disease. Seeing these changes may result in changes to the treatment plan.

NCT ID: NCT04766632 Recruiting - High Grade Glioma Clinical Trials

Contribution of Cerebral 18F-DOPA PET-CT Scan in High-grade Recurrent Gliomas

DORA
Start date: May 18, 2021
Phase: N/A
Study type: Interventional

High-grade gliomas represent 60 to 70% of adult glial tumors and are highly aggressive with average survival from 12 to 15 months for glioblastomas (WHO grade IV gliomas) and from 2 to more than 5 years for WHO grade III gliomas. The treatment of initial stage high-grade gliomas is made with the most complete excision surgery possible followed by adjuvant radiochemotherapy or an exclusive radiochemotherapy if excision is impossible. Most often, these treatments are followed by adjuvant chemotherapy. Treatment of recurrence is most often re-irradiation according to stereotaxic modalities. Determination of the volumes to be irradiated conditions effectiveness and tolerance in the planning of these treatments. The definition of Gross Tumor Volume (GTV) is based on enhancing - T1 magnetic resonance imaging (MRI) after gadolinium injection. A margin of 1-2 mm is applied to define the PTV (Planning Target Volume) or irradiated volume, approximately equal to the GTV-MRI. Amino acid PET-CT (Positon Emission Tomography with Computed Tomography) could be an interesting alternative to tumor delineation because its results, do not depend on the rupture of the blood-brain barrier. Several studies have used amino acid PET in the planning of radiotherapy treatment for high-grade gliomas, but without a well-conducted prospective study. In the recurrent high-grade glioma population, no studies have been performed with 18F-DOPA.( 6-fluoro-[18F]-L-dihydroxyphenylalanine) The question therefore relates to the interest of cerebral 18F-DOPA PET-CT to improve the delineation of the volumes to be re-irradiated, during the recurrence of high-grade gliomas, and on the optimal methodology for determining GTV- PET. To compare GTV-TEP and GTV-MRI volumes with each other, and the r-GTV, volume corresponding to the relapse objectified on the follow-up MRI, the analysis will be based on 3 parameters: - DICE index, similarity index between 2 volumes, - Contoured Common Volume (VCC), intersection of 2 volumes between them, - Additional Contoured Volume (VSC), total volume delineated with imaging minus the common volume between 2 imageries. Thus, within the rGTV relapse volume, it's important to know whether VSC of 18F-DOPA PET-CT is significant compared to that of MRI and would thus allow better definition of the volumes to be irradiated.

NCT ID: NCT04758533 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Clinical Trial to Assess the Safety and Efficacy of AloCELYVIR With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG) in Combination With Radiotherapy or Medulloblastoma in Monotherapy

AloCELYVIR
Start date: April 19, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The aim of this study is to assess the safety and efficacy of AloCELYVIR, which consist in bone marrow-derived allogenic mesenchymal stem cells infected with an oncolytic Adenovirus, ICOVIR-5. It has recently been proven that this type of cells are able of transporting oncolytic substances to tumor targets that are difficult to reach, such as medulloblastomas and gliomas, youth cancers located in the cranial cavity that have a poor prognosis and a fatal outcome. In addition, to exerting an anti-tumor action, this virus has the ability to stimulate the immune response, making the therapy even more effective. Thus, the diffuse intrinsic pontine glioma and the medulloblastoma in relapse/progression have been chosen to study the potential of this new advanced therapy through a weekly infusion for 8 weeks.

NCT ID: NCT04749641 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Neoantigen Vaccine Therapy Against H3.3-K27M Diffuse Intrinsic Pontine Glioma

ENACTING
Start date: March 8, 2021
Phase: Phase 1
Study type: Interventional

Diffuse intrinsic pontine gliomas (DIPGs), which diffusely occupy the pons of brainstem, are the deadliest primary brain cancer in children. Biopsy for pathology plus radiotherapy remains the current standard-of-care treatment that is minimal effective. Thus, the median overall survival after diagnosis is just 10 months. Recent studies have identified a lysine 27-to-methionine (K27M) somatic mutation at histone H3 variant (H3.3), as a feature mutation in DIPGs. Several preclinical studies have already demonstrated H3.3-K27M as a promising target for immunotherapy. The researched vaccine is a cancer-treatment vaccine containing an H3.3-K27M targeted neoantigen peptide, that can be taken up by antigen-presenting cells (APCs). APCs can present the peptide with the major histocompatibility complex (MHC) molecules on cell surface, thereby activating neoantigen-specific T cells and triggering corresponding cytotoxic T cell immune responses to eliminate H3.3-K27M-expressing DIPG cells. The main goal of this study is investigating the safety and preliminary efficacy of the vaccine in treating newly-diagnosed DIPGs when the vaccine is administered in combination with the standard-of-care treatment.

NCT ID: NCT04740190 Recruiting - Clinical trials for Recurrent Glioblastoma

Talazoparib - Carboplatin for Recurrent High-grade Glioma With DDRd

TAC-GReD
Start date: January 1, 2021
Phase: Phase 2
Study type: Interventional

In view of the strong biological rationale of employing PARP inhibition in high grade glioma, the current study purposes testing of talazoparib in a biomarker-enriched group of glioma. Carboplatin will be added to sensitize the tumor to PARP inhibition, and low dose radiation therapy will be applied to increase talazoparib drug penetration through blood-brain barrier. The goal is to estimate the effect size of such combinational treatment approach in recurrent high-grade glioma with DNA damage repair deficiency (dDDR)

NCT ID: NCT04738110 Recruiting - Glioma Clinical Trials

Post-operative Imaging in High Grade Glioma: is Management Influenced?

PIGMI
Start date: July 20, 2020
Phase:
Study type: Observational

Magnetic resonance imaging (MRI) is likely to play an important role in the management of high grade glioma. Appropriate and timely neuroimaging in the follow up period is believed to be crucial in making subsequent management decisions. However, there is a paucity in the literature providing evidence to support this. The aim of this study is to determine whether neuroimaging performed at each component of the patient pathway after initial high grade glioma treatment, actually results in a real change in management (as opposed to a perceived change in management). The main emphasis is on all imaging used at the time of a MDM, however, we will also study specifically dynamic susceptibility contrast-enhanced (DSC) MRI and dynamic contrast enhanced (DCE) MRI. The study is in the format of Mock MDMs to be compatible with real life decision making. Using retrospective identical information available at the MDM i.e. compiled recent correspondence, histopathological and molecular information, the MDM members (oncology nurse, oncologist, neurosurgeon, neuroradiologist, pathologist/molecular scientist) will prospectively determine the patient management with and without the imaging.

NCT ID: NCT04737577 Recruiting - High Grade Glioma Clinical Trials

Glioma Supra Marginal Incision Trial

G-SUMIT
Start date: February 5, 2021
Phase: N/A
Study type: Interventional

G-SUMIT is a pilot, phase II,randomized controlled trial to evaluate the feasibility of performing a large-scale trial in patients undergoing surgery for first-time diagnosis of high grade glioma (HGG) in a surgically favorable anatomical location to answer the following: Does extending the margin of resection 1 cm beyond visible enhanced volume on MRI result in (a) an increase in overall survival? (b) result in a similar rate of "clinically-significant" neurological worsening during 30 days post surgery and quality of life at 6 and 12 months?