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Glioma, Malignant clinical trials

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NCT ID: NCT06468176 Not yet recruiting - Glioma, Malignant Clinical Trials

Efficacy of a Mixed Distancial Neuropsychological Rehabilitation Program in Patients With Grade 2 or 3 Diffuse Glioma

FREEDOME
Start date: June 15, 2024
Phase: N/A
Study type: Interventional

Diffuse low-grade glioma are rare brain tumors affecting young subjects (median age at diagnosis 38 years for grade 2 and 49 years for grade 3). Cognitive symptoms are common in these patients, including memory, attention and executive function disorders. These disorders may have a deleterious impact on patients' professional, family and social lives, and have a negative impact on their quality of life. The benefits of cognitive rehabilitation have been demonstrated in other neurological pathologies. Furthermore, due to limited access to rehabilitation by neuropsychologists, some studies have evaluated the impact of digital cognitive rehabilitation programs. However, it cannot replace human support.

NCT ID: NCT06397560 Not yet recruiting - Glioma Clinical Trials

PrOton Pulsed reduCed dOse Rate Radiotherapy for Recurrent CNS maligNancies Trial

POPCORN
Start date: June 2024
Phase: N/A
Study type: Interventional

The purpose of this research study is to see if a specific type of radiation therapy, called "proton pulsed reduced dose rate" or "PRDR radiotherapy" has any benefits at dose levels and number of fractions thought to be acceptable in earlier research studies. The researchers want to find out what effects (good and bad) PRDR has on people with cancer in the brain called a "recurrent high-grade glioma" meaning that it grows fast, can spread quickly, and it has come back or gotten worse after being treated previously.

NCT ID: NCT06323408 Not yet recruiting - Medulloblastoma Clinical Trials

Integrated Analysis of Therapy Response and Resistence in Embryonal Tumors and Gliomas

BZKF-AYA
Start date: June 2024
Phase:
Study type: Observational

The treatment of adolescents and young adults (AYA, 15 to 39 years) with malignant intra-axial CNS parenchymal tumors such as IDH-mutated gliomas, medulloblastomas and ependymomas is still not curative in all cases. The tumor biology and clinical needs to diagnose and treat these tumors are comparable across all age groups, so an integrated treatment environment overseen by adult and pediatric neuro-oncology specialists seems promising to leverage synergisms and advance diagnostic and therapeutic development in these tumors. A comprehensive, prospective and integrated biomaterial and imaging-based pipeline for the multi-faceted evaluation of AYAs has not yet been established for AYA patients with brain tumors in Germany. Current diagnostic platforms neglect the integrative processing of data from MRI and FET-PET imaging, radiotherapy plans, tumor tissue, liquid biopsies and clinical data as well as prognostic markers. A prospective AYA pipeline can therefore enable a better understanding of the aforementioned high-risk CNS malignancies and promises clinical advances for AYA patients and the clinical and scientific research landscape.

NCT ID: NCT06258018 Not yet recruiting - Glioma, Malignant Clinical Trials

Niraparib and Temozolomide in Patients Glioblastoma

ONC-2022-001
Start date: March 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The study evaluates safety, tolerability, pharmacokinetics at recommended phase II dose (RP2D) and preliminary antitumor activity of Niraparib + dd-TMZ "one week on, one week off" in patients affected by recurrent GBM IDH wild-type and recurrent IDH mutant (WHO grade 2-4) gliomas. The treatment will be administered until progressive disease, unacceptable toxicity, consent withdrawal, lost to follow-up or death. The entire study is expected to last approximately 40 months.

NCT ID: NCT06172595 Not yet recruiting - Glioma, Malignant Clinical Trials

FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma

FET PET in HGG
Start date: December 21, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is to evaluate the performance characteristics of O-(2-[18F]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of [18F]FET-PET in delineating disease. The main question[s] it aims to answer are: - whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression - whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT of the brain in SGH.

NCT ID: NCT06169280 Not yet recruiting - Glioma, Malignant Clinical Trials

Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Glioma

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

The goal of this clinical trial is to learn about the safety and feasibility of administering repeated doses of neural stem cell (NSC)-conditionally replicative adenovirus (CRAd)-survivin (S)-protomer (p)k7, in persons with newly diagnosed high grade glioma. The main questions it aims to answer are: - whether multiple doses of NSC-CRAd-S-pk7 are safe and feasible - how multiple doses of NSC-CRAd-S-pk7 influence tumor response, overall survival, time to tumor progression, and quality of life. Participants will: - undergo a biopsy to confirm high grade glioma, then receive the first dose of NSC-CRAd-S-pk7 into the brain - about 2 weeks later, undergo surgery to remove the tumor and receive the second dose of NSC-CRAd-S-pk7 into the brain - start chemoradiation about 2 weeks after surgery, then about 2 weeks later, receive the 3rd dose of NSC-CRAd-S-pk7 into the brain - four weeks later, at the end of chemoradiation, receive a fourth dose of NSC-CRAd-S-pk7 into the brain. - after radiation is finished, receive standard of care chemotherapy and tumor-treating fields. Two additional doses of NSC-CRAd-S-pk7 will be given every 4 weeks. Every other patient enrolled will receive N-acetylcysteine amide (NACA), from registration until the day prior to surgery and the second dose of NSC-CRAd-S-pk7.

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: NCT05764460 Not yet recruiting - Clinical trials for Cognitive Dysfunction

Social Cognition and Language in Patients With Gliomas

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

Patients with gliomas often suffer from lower quality of life, and detrimental social interactions after diagnosis. Two cognitive processes are crucial for maintaining healthy social relationships and interacting with others: social cognition and language. Social cognition is the ability to recognize and process mental and emotional states and to react appropriately in social situations. Social cognition and language are separate cognitive functions that can be affected in different ways in patients with brain injury. Also, distinct cognitive measurement instruments are used to assess both processes. However, there appears to be a certain overlap between social cognition and language. Reacting adequately in social situations requires both verbal and non-verbal communication and to communicate feelings, thoughts and intentions, people often use language. That is, verbal communication is part of a symbolic system that makes social interaction possible. Therefore, language abilities seem to be important to social cognition. Research shows that language is frequently impaired in adult patients with gliomas. Importantly, recent evidence suggests that social cognition can also be impaired in this patient group. However, no studies have been conducted into the relationship between social cognition and language in patients with gliomas. Increasing knowledge on the overlap between both functions, more specifically the influence of language difficulties on social cognition, will improve diagnostic accuracy. Eventually, this will lead to better, tailor-made treatments for these problems that negatively affect daily functioning. Objective: The main research objective is to examine the influence of language impairments on different social cognition processes, i.e., emotion recognition, Theory of Mind (ToM) and affective empathy, in patients with (suspected) gliomas. Secondary objectives are 1) to determine if patients with gliomas show impairments in different aspects of social cognition, i.e. emotion recognition, ToM, empathy and self-awareness; 2) to assess specific language impairments by looking at item-level characteristics of language tasks (e.g., analyses of word properties of fluency tasks, errors during object naming or spontaneous speech), and 3) to determine which tumor characteristics (low- or high-grade, genetic mutation, tumor location) are associated with different aspects of language and social cognition.

NCT ID: NCT05555550 Not yet recruiting - Glioma Clinical Trials

Evaluation of 18F-Fluciclovine Positron Emission Tomography - Magnetic Resonance Imaging (PET-MRI) in LGG

Start date: July 2024
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to see if 18F-Fluciclovine (Axumin®) is useful and safe in the management of children with Low Grade Gliomas (LGG). Imaging with 18F-Fluciclovine PET-MRI will be performed prior to initiation of therapy for LGG, and then 3 months, and 1 year after starting therapy. Changes in 18F-Fluciclovine uptake will be compared to changes in MRI measurements at 3 months and 1 year as compared to baseline.

NCT ID: NCT05366062 Not yet recruiting - Glioma, Malignant Clinical Trials

ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab

Start date: July 1, 2022
Phase: Phase 2
Study type: Interventional

This is a treatment clinical trial to assess the efficacy of ERC1671 in combination with bevacizumab and pembrolizumab in patients with GBM that has progressed following treatment with radiation and temozolomide. Patients will have surgery to collect the maximum amount of GBM tissue that can be reasonably collected. This tissue will be used to manufacturer ERC1671 for the patient. The patients will receive ERC1671 in combination with GM-CSF and cyclophosphamide, in combination with bevacizumab and pembrolizumab.