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Glioblastoma clinical trials

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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: NCT06264388 Recruiting - Clinical trials for Anaplastic Astrocytoma

DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic Astrocytoma

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

The purpose of this study is to determine if the investigational products, DB107-RRV and DB107-FC, as a combination treatment will shrink high-grade glioma (HGG) in patients with recurrent/progressive, resectable or unresectable disease and increase the time that disease is controlled.

NCT ID: NCT06253234 Recruiting - Clinical trials for WHO Grade IV Gliomas

Safety and Efficacy Study for DC Vaccine in Recurrent or Progressive High-grade Gliomas

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

This is a single-center, open-label, multi-dose phase I clinical trial evaluating the safety, tolerability, and preliminary efficacy of ZSNeo-DC1.1, a personalized dendritic cell injection, in subjects with recurrent or progressive WHO grade III-IV gliomas post-standard treatment. The subjects are adult GBM patients who have undergone surgical resection for recurrence. After the completion of reoperation, subjects will receive autologous DC vaccine treatments as scheduled. The autologous genetic-modification-free DC cells will be loaded with multiple tumor neoantigen peptides and administered (i.h) to subjects. After 3 injections, the investigator will review subject's tolerance and compliance. The DLT observation period spans from the initial injection to 21 days after the third injection, aligning with the activation of anti-tumor immune response. About 15 subjects will be enrolled. The study utilizes a fixed dose of 1×10^7 cells per injection and employs two immunization schedules A or B. The trial is conducted in two stages: Dose Confirmation Stage: Enrollment of six subjects with recurrent or progressive gliomas following standard treatment. Each subject receives six subcutaneous injections of ZSNeo-DC1.1. Utilization of a standard "3+3" design for fixed dose confirmation and exploration of immunization schedules A and B. Dose Expansion Stage: Enrollment of at least six subjects with recurrent or progressive gliomas post-standard treatment. Administration of six subcutaneous injections of ZSNeo-DC1.1 to each subject, further investigating the safety and preliminary efficacy of ZSNeo-DC1.1 injection.

NCT ID: NCT06220552 Recruiting - Clinical trials for Recurrent Glioblastoma

The Efficacy and Safety of Low-dose Radiotherapy Combined With Sintilimab and Temozolomide in Recurrent Glioblastoma

Start date: December 27, 2023
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm, phase II clinical trial to explore the efficacy and safety of low-dose radiotherapy combined with programmed death 1 (PD-1) inhibitor (sintilimab) and temozolomide in recurrent glioblastoma. The eligible patients are scheduled to administered sintilimab 200mg D1 Q3W temozolomide 50mg/m2 QD and radiotherapy 1Gy/1F D1/D2/D8/D15 Q3W for 4-6 cycles, then sintilimab for maintenance. The overall primary study hypothesis is that the combination regimen of low-dose radiotherapy, sintilimab and temozolomide is safe and feasible in the treatment of recurrent glioblastoma.

NCT ID: NCT06193538 Recruiting - Clinical trials for Advanced Glioblastoma Patients

The Safety and Effectiveness of NV-A01 in Glioma Patients

Start date: September 14, 2023
Phase: Phase 1
Study type: Interventional

The goal of this clinical trial is to learn about the safety and effectiveness of NV-A01 in the treatment of advanced glioma patients. The main questions it aims to answer are: 1. The safety of NV-A01 in the treatment of advanced glioblastoma patients. 2. The effectiveness of NV-A01 in treating patients with advanced glioblastoma.

NCT ID: NCT06186401 Recruiting - Glioblastoma Clinical Trials

Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T Cells

Start date: March 4, 2024
Phase: Phase 1
Study type: Interventional

This phase I trial tests the safety, side effects, and best dose of E-SYNC chimeric antigen receptor (CAR) T cells after lymphodepleting chemotherapy in treating patients with EGFRvIII positive (+) glioblastoma. Chimeric antigen receptor (CAR) T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so the CAR T cells will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Lymphodepleting chemotherapy with cyclophosphamide and fludarabine before treatment with CAR T cells may make the CAR T cells more effective.

NCT ID: NCT06183983 Recruiting - Glioblastoma Clinical Trials

Hitting the Mark: Introducing State-of-the-art MRI for Precision Radiotherapy of Glioblastoma

MOSAIC
Start date: January 3, 2024
Phase: N/A
Study type: Interventional

The goal of this prospective cohort study is to assess the potential of advanced MRI for improved radiotherapy target delineation in patients diagnosed with glioblastoma. The main questions it aims to answer are: - How does the coverage of the recurrence volume by a radiotherapy plan based on advanced MRI compare to the coverage by the clinical radiotherapy plan? - How does the distribution of the dose to organs at risk by a radiotherapy plan based on advanced MRI compare to the distribution by the clinical radiotherapy plan? Participants will undergo an extended MRI-protocol prior to radiotherapy. This extended MRI-protocol includes the clinical brain tumor imaging protocol plus additional advanced MRI-sequences. Radiation treatment and patient follow-up will occur according to the clinical standard.

NCT ID: NCT06160596 Recruiting - Clinical trials for Small-cell Lung Cancer

Analyzing and Solving Exceptional Long-term Survivors in Solid Tumors With Poor Prognosis

ROSALIND
Start date: November 1, 2023
Phase:
Study type: Observational

This is a retrospective, exploratory, multi-center, translational, 3 cohorts case control matched study conducted in patients harboring a solid tumor with poor prognosis who presented a long-term (case) and standard (standard) survival. Patients with: - Cohort A: metastatic pancreatic ductal adenocarcinoma - Cohort B: glioblastoma IDHwt - Cohort C: extensive small cell lung cancer This research aims to integrate data generated from clinical records, imaging, multi-omics and bioinformatics approaches to discriminate case and control and then to identify new therapeutic targets. Analyses will be performed depending on the tumor samples available with at least 3 omics levels and according to scientific advances; genomic, epigenomic, proteomics, metabolomics, transcriptomic, microbiomic.

NCT ID: NCT06157541 Recruiting - Clinical trials for Glioblastoma Multiforme

T Cells and Pembrolizumab for Recurrent and Newly Diagnosed Glioblastoma

TCaP
Start date: February 8, 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: NCT06147505 Recruiting - Glioblastoma Clinical Trials

Natural Killer (NK) Cells (XS005) Injection Combined With Stupp Regimen for Adjuvant Chemotherapy in Subjects With Primary Glioblastoma(GBM)

Start date: October 29, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The main objective of this clinical study is to evaluate the safety of XS005 cell which contains Natural Killer (NK) cells and culture-expanded injection; to determine the maximum tolerated dose . Furthermore, initial efficacy will be examined.