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Glioma clinical trials

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NCT ID: NCT05478837 Recruiting - Clinical trials for Diffuse Midline Glioma, H3 K27M-Mutant

Genetically Modified Cells (KIND T Cells) for the Treatment of HLA-A*0201-Positive Patients With H3.3K27M-Mutated Glioma

PNOC018
Start date: July 20, 2023
Phase: Phase 1
Study type: Interventional

This phase I, first-in-human trial tests the safety, side effects, and best dose of genetically modified cells called KIND T cells after lymphodepletion (a short dose of chemotherapy) in treating patients who are HLA-A*0201-positive and have H3.3K27M-mutated diffuse midline glioma. KIND T cells are a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory into KIND T cells so they will recognize certain markers found in tumor cells. Drugs such as cyclophosphamide and fludarabine are chemotherapy drugs used to decrease the number of T cells in the body to make room for KIND T cells. Giving KIND T cells after cyclophosphamide and fludarabine may be more useful against cancer compared to the usual treatment for patients with H3.3K27M-mutated diffuse midline glioma (DMG).

NCT ID: NCT05476939 Recruiting - Clinical trials for Diffuse Intrinsic Pontine Glioma

Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0

BIOMEDE 2
Start date: September 29, 2022
Phase: Phase 3
Study type: Interventional

The BIOMEDE 2.0 study is the second stage of the BIOMEDE multi-arm, multistage rolling programme (adaptive platform protocol). It is a multicenter, randomized, open-label, controlled phase-3 trial evaluating efficacy of ONC201 in comparison with everolimus (primary objective based on internal comparison) and subsequently to historical controls. Two treatment groups will be compared. A switch between treatment groups is allowed after confirmation of the disease progression (real-time central review blinded to the treatment arm allocation). Study treatment will be continued until centrally confirmed disease progression (either radiologically or histologically), unacceptable toxicity or consent withdrawal. The final conclusion of the trial will be successful for ONC201, if ONC201 is found significantly superior to everolimus in terms of centrally-reviewed PFS (Progression-free survival) from randomization (internal comparison) either overall, considering ND-DMG and DIPG-patients together, or in the subgroup of ND-DMG patients alone. In other cases, Everolimus will remain the standard arm unless it appears associated with an excess of toxicity compared to ONC201 which could then be discussed as a new standard.

NCT ID: NCT05475522 Recruiting - Metastases to Brain Clinical Trials

Intraoperative Sonographically Versus Fluorescence-guided Resection of Contrast-enhancing Gliomas and Brain Metastases

SONOFLUO
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Objective of the study is to determine whether intraoperative ultrasound guided resection of gliomas with contrast enhancement in magnetic resonance imaging and brain metastases can achieve as high rate of gross total resection as fluorescence-guided surgery with 5-aminolevulinic acid

NCT ID: NCT05474573 Recruiting - Glioma, Malignant Clinical Trials

Concurrent Fluorescence and Sonographically Guided Eradication of Contrast-enhancing Gliomas and Metastases

CONFLUENSE
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Objective of the study is to determine whether combined use of intraoperative fluorescence with 5-aminolevulinic acid (5-ALA) and sonography can achieve higher rate of gross total resection of contrast-enhancing gliomas and brain metastases compared to intraoperative fluorescence with 5-ALA alone.

NCT ID: NCT05473923 Recruiting - Clinical trials for Recurrent High Grade Glioma

PTCs-based Precision Treatment Strategy on Recurrent High-grade Gliomas

Start date: August 12, 2022
Phase: Early Phase 1
Study type: Interventional

This trial is an open-label, single-arm, phase 0/1 study of high-grade glioma that aims to evaluate the feasibility, preliminary efficacy and safety of the precision treatment strategy.

NCT ID: NCT05470374 Recruiting - Clinical trials for Non-enhancing Cerebral Gliomas

Intraoperative Sonographically Guided Resection of Non-enhancing Gliomas

SONOGLIO
Start date: September 1, 2022
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether intraoperative ultrasound guided resection of glioma without contrast enhancement in magnetic resonance imaging can achieve higher extent of resection than surgery without intraoperative sonography

NCT ID: NCT05464992 Recruiting - Glioma Clinical Trials

Use of CEST (Chemical Exchange Saturation Transfer) Imaging in PET/MRI

GlioCEST
Start date: December 28, 2022
Phase: N/A
Study type: Interventional

Standard Magnetic Resonance Imaging (MRI) is based on the excitation of hydrogen nuclei that are presents in water molecules, which abundance in human body allows for obtention of superior contrast. However, assessing the presence of other molecules than water in tissues is also of great clinical interest to probe metabolites related to physiological body function and pathological conditions. Chemical exchange saturation transfer (CEST) allow to overcome some limitations of proton magnetic resonance spectroscopy (1H-MRS) by exploiting chemical properties of the targeted molecule through a continuous process of re-saturation and exchange, and thus detecting it with increased sensitivity, from two orders of magnitude. Moreover, CEST technique is based on imaging sequences and can therefore benefit from well-known fast acquisition strategies, as well as improved spatial resolution.

NCT ID: NCT05459441 Recruiting - Glioma Clinical Trials

Efficacy and Safety Evaluation of Percutaneous Ommaya Capsule Injection of Autologous Bi-dimensional Specific T Cells in the Treatment of Glioma and in Combination With Pemetrexed in the Treatment of Brain/Meningeal Metastases

Start date: January 1, 2022
Phase: Early Phase 1
Study type: Interventional

Cerebral metastases are common intracranial tumor, its incidence increased year by year, in recent years, although the whole brain radiation therapy, surgical resection, stereotactic radiosurgery treatment, targeted drugs, and other comprehensive treatment in patients with symptoms of mitigation and the extension of survival has played a positive role, but due to individual differences, treatment in patients with poor compliance were a lot of factors, Further treatment of brain metastases after conventional treatment requires the assistance and cooperation of clinical multi-disciplines. To evaluate the efficacy and safety of percutaneous Ommaya capsule injection of autologous bi-dimensional specific T cells in the treatment of glioma and combined with pemetrexed in the treatment of brain/meningeal metastasis. Using translational research techniques and means, to find molecular indicators related to clinical prognosis and outcome, establish the clinical use standard of this holistic treatment technology, and popularize it in multi-centers.

NCT ID: NCT05413304 Recruiting - Glioma Clinical Trials

Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis

Start date: April 7, 2023
Phase: Phase 1
Study type: Interventional

Background: Diffuse midline gliomas are the most aggressive brain tumors of childhood and young adults. Most people with these tumors survive less than 2 years. Researchers want to see if an anticancer drug (abemaciclib) can help. Objective: To see if researchers can measure how much abemaciclib is in a person's brain tumor and brain fluid after they take the drug for a few days. Eligibility: People aged 18 to 39 with recurrent high-grade glioma or diffuse midline glioma. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Tests of heart function Imaging scans of the brain, with a contrast agent Screening tests will be repeated during the study. Participants will also have chest X-rays. Participants will take abemaciclib by mouth twice a day for 4 and a half days. Participants will undergo surgery. They will have either a tumor biopsy (a needle will be inserted to remove a small piece of tissue) or a surgical resection (part or all of the tumor will be removed). A small tube (catheter) will be placed in their brain for 48 hours to collect fluid samples. They will have a neurological exam every few hours while the tube is in place. Two days later, the tube will be removed without surgery. Participants will stay in the hospital for about 4 days for treatment. Based on the results of abemaciclib levels in the brain, participants may keep taking abemaciclib and another drug (temozolomide) by mouth until their cancer gets worse or they have bad side effects. While taking these two drugs, participants will come back to the clinic for follow-up routinely. They will be followed by the study for life.

NCT ID: NCT05406700 Recruiting - Glioma, Malignant Clinical Trials

Niraparib In Recurrent IDH 1/2 Gliomas

Start date: May 18, 2023
Phase: Early Phase 1
Study type: Interventional

This is a randomized, two-arm, open-label, phase 0 trial to assess intratumoral pharmacokinetics and pharmacodynamics of niraparib in subjects with progressive IDH1 or IDH2 mutant glioma. - This research study involves an experimental treatment called Niraparib.