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Glioblastoma Multiforme clinical trials

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NCT ID: NCT06329570 Not yet recruiting - Neoplasms Clinical Trials

Safety and Efficacy of Bevacizumab in Combination With NaviFUS System for the Treatment of Recurrent Glioblastoma Multiforme (rGBM)

Start date: July 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This will be a prospective, open-label, single-arm pilot study to investigate the safety and efficacy of Bevacizumab (BEV) in combination with microbubble (MB)-mediated FUS in patients with recurrent GBM. BEV represents the physician's best choice for the standard of care (SoC) in rGBM after previous treatment with surgery (if appropriate), standard radiotherapy with temozolomide chemotherapy, and with adjuvant temozolomide.

NCT ID: NCT06283927 Recruiting - Glioblastoma Clinical Trials

The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)

RECSUR
Start date: January 1, 2023
Phase:
Study type: Observational

Previous evidence has indicated that resection for recurrent glioblastoma might benefit the prognosis of these patients in terms of overall survival. However, the demonstrated safety profile of this approach is contradictory in the literature and the specific benefits in distinct clinical and molecular patient subgroups remains ill-defined. The aim of this study, therefore, is to compare the effects of resection and best oncological treatment for recurrent glioblastoma as a whole and in clinically important subgroups. This study is an international, multicenter, prospective observational cohort study. Recurrent glioblastoma patients will undergo tumor resection or best oncological treatment at a 1:1 ratio as decided by the tumor board. Primary endpoints are: 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks after surgery and 2) overall survival. Secondary endpoints are: 1) progression-free survival (PFS), 2) NIHSS deterioration at 3 months and 6 months after surgery, 3) health-related quality of life (HRQoL) at 6 weeks, 3 months, and 6 months after surgery, and 4) frequency and severity of Serious Adverse Events (SAEs) in each arm. Estimated total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year. The study has been approved by the Medical Ethics Committee (METC Zuid-West Holland/Erasmus Medical Center; MEC-2020-0812). The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.

NCT ID: NCT06271421 Recruiting - Clinical trials for Glioblastoma Multiforme

NanoTherm In Adjuvant Therapy of Glioblastoma Multiforme

ANCHIALE
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Glioblastoma multiforme (GBM), the most common and malignant primary brain tumor in adults is classified as a World Health Organisation (WHO) grade 4. Surgical removal of the tumor is the primary method of treatment. Unfortunately, because GBM is a disease of the entire brain, total resection is not possible. Therefore, the use of radiotherapy and/or chemotherapy is considered as Stupp protocol. Patients with recurrent GBM will be included in the ANCHIALE study. The goal of the trial is to evaluate the efficacy and tolerance of using the NanoTherm therapy system in recurrent GBM. The main questions it aims to answer are: 1. how NanoTherm therapy influences overall survival, and progression free survival; 2. what is the tolerance of NanoTherm therapy in terms of side effects (allergies, intracranial bleeding, infections, brain edema, increased intracranial pressure) and quality of life. Participants will undergo: - initial visit, considering the inclusion/exclusion criteria, neurological examination, and surveys regarding daily functioning and quality of life; - standard neurosurgical operation aimed, if possible, complete removal of the recurrent GBM and administration of NanoTherm ASI - a sterile suspension of iron oxide nanoparticles. A catheter will be implanted allowing for measurement of temperature during the first activation in the magnetic field; - between the 6th and 10th day after tumor resection, a standard computerized tomography (CT) scan of the head will be performed for routine postoperative evaluation; - after the first activation (10th day), the catheter will be removed; - subsequently, for 6 times, the patient will be subjected to the variable magnetic field of the NanoActivator® to induce hyperthermia - activations will be conducted on the 10th, 14th, 17th, 21st, 24th, and 28th day; - for up to 2 years post-procedure, a CT scan with an evaluation of treatment efficacy will be performed; - during follow-up visits for up to 2 years after the surgical procedure, a neurological examination, assessment of adverse symptoms, number of hospitalizations, number of medical visits, clinimetric assessment regarding quality of life, neurological deficit and degree of disability will be conducted. Researchers will compare NanoTherm group with patients undergoing Stupp protocol treatment for the abovementioned effects.

NCT ID: NCT06241391 Not yet recruiting - Glioma Clinical Trials

Ga-68 Prostate Specific Membrane Antigen PET/CT in Gliomas

Start date: February 2024
Phase: N/A
Study type: Interventional

As a part of molecular imaging, many PET tracers have been investigated in this regard. Those include 18F-FDG being glucose analogue, 18F-FLT representing nucleoside metabolism, and 18F-FDOPA, 18F-FET, 11C-MET as amino acids analogues. Among these, 18F-FDG is the most commonly used tracer due to its broader use and easy availability. However, high physiological uptake in the brain is a significant limitation. The main limitation of other tracers is the need for onsite cyclotrons for their production, making their availability difficult. So, the search for an ideal modality is still ongoing, and the latest addition to this search is a radio ligand labeled Prostate Specific Membrane Antigen (PSMA). It is a new but potentially promising radiotracer, currently showing its utility in different malignancies. Investigators, therefore, aim to identify whether Ga-68 PSMA PET-CT has better diagnostic accuracy in the detection of recurrent gliomas than conventional imaging modalities.

NCT ID: NCT06218524 Not yet recruiting - Clinical trials for Glioblastoma Multiforme

The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM

Start date: December 1, 2024
Phase: Phase 2
Study type: Interventional

The study of investigators indicated that TMZ can up-regulate dopamine D2 receptor (DRD2) expression, and mediates Ferroptosis inhibition and chemoresistance of GBM. The clinical data also proved that the DRD2 expression in recurrent GBM is significantly higher than that in primary GBM. Moreover, the DRD2 antagonist haloperidol can attenuate the above function of DRD2, and increase the sensitivity of GBM to the TMZ by inducing fatal autophagy and ferroptosis. In xenograft mice, the combined usage of haloperidol and Temozolomide (TMZ) can significantly inhibit tumor growth and increase overall survival. The investigators' findings have been published in Clinical cancer research. Haloperidol known as a butylbenzene antipsychotic drug, has been widely used in several kinds of mental illnesses, such as depression, schizophrenia, and Bipolar disorder. And the safe dosage of the haloperidol is clear so far. So in this study, the investigators will recruit the patients who suffered from recurrent GBM, and evaluate the effectiveness of single TMZ chemotherapy or combined with haloperidol.

NCT ID: NCT06157541 Not yet recruiting - Clinical trials for Glioblastoma Multiforme

T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma

TCaP
Start date: January 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical trial is to test a combined therapy approach (allogeneic cytomegalovirus [CMV]-specific T cells and pembrolizumab) in patients with brain cancer. The type of brain cancer being studied is glioblastoma multiforme/astrocytoma grade 4. The purpose of part 1 of this study is to determine the maximum-tolerated dose and/or recommended dose(s) for future exploration of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab in patients with recurrent GBM/astrocytoma grade 4. Part 2 of the study aims to investigate the anti-tumour activity of allogeneic CMV-specific T cells as monotherapy or in combination with pembrolizumab, assessed by magnetic resonance imaging and survival, in patients with recurrent or newly diagnosed GBM/grade 4 astrocytoma.

NCT ID: NCT06146738 Recruiting - Glioblastoma Clinical Trials

The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)

PALSUR
Start date: January 1, 2023
Phase:
Study type: Observational

There is no consensus on the optimal treatment of patients with high-grade glioma, especially when patients have limited functioning performance at presentation (KPS ≤70). Therefore, there are varied practice patterns around pursuing biopsy, resection, or palliation (best supportive care). This study aims to characterize the impact of palliative care versus biopsy versus resection on survival and quality of life in these patients. Also, it will aim to determine if there is a subset of patients that benefit the most from resection or biopsy, for which outcome, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 3-arm cohort study of observational nature. Consecutive HGG patients will be treated with palliative care, biopsy, or resection at a 1:3:3 ratio. Primary endpoints are: 1) overall survival, and 2) quality of life at 6 weeks, 3 months and 6 months after initial presentation based on the EQ-5D, EORTC QLQ C30 and EORTC BN 20 questionnaires. Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

NCT ID: NCT06146725 Recruiting - Glioblastoma Clinical Trials

The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)

RESBIOP
Start date: January 1, 2023
Phase:
Study type: Observational

There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment. This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

NCT ID: NCT06059690 Recruiting - Clinical trials for Glioblastoma Multiforme

Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells

Start date: September 6, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this project is to validate a new combined MRI and PET imaging technique as a biomarker or measure of glycolysis in brain tumors. To accomplish this, the investigators propose obtaining image-guided measures of tissue pH and biopsied tissue in tumor areas selected for bulk resection surgery. Investigators will then correlate the imaging measurements with pH, RNA expression, protein expression, and bioenergetics measurements of key glycolytic enzymes.

NCT ID: NCT06054529 Recruiting - Clinical trials for Glioblastoma Multiforme

Spatiotemporal Dimensions of Metabolism in Autochthonous Tumors of GBM Patients

GBM-FLUX2
Start date: September 11, 2023
Phase:
Study type: Observational

To learn how altered metabolism in GBM causes tumor growth and resistance to drug therapy. In this pilot research study, we will dose GBM patients with a form of nicotinamide (a natural vitamin) that we can track. The nicotinamide will be converted to methyl nicotinamide (MeNAM) in the tumor. We will measure how fast the nicotinamide is converted to methyl nicotinamide. We believe that the speed of this chemical reaction in the tumor (fast versus slow) may be correlated with GBM aggressiveness