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GBM clinical trials

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NCT ID: NCT06439849 Available - GBM Clinical Trials

A Single Patient Compassionate Use Clinical Trial for the Use of L-S-Gboxin (Lyophilized Form of S-Gboxin) for the Treatment Diffuse Midline Glioma, H3 K27/28-altered (DMG), Including Diffuse Intrinsic Pontine Glioma (DIPG)

TRIANGLE
Start date: n/a
Phase:
Study type: Expanded Access

F. 50y.o. 77kg, DS confirmed 18 Nov. 2022 Received treatment: 11 courses of TMZ (240mg) Radiotherapy 30 courses of 1.8Gr (total 54 Gr, TMZ 140 mg on RT). Bevacizumab intravenously -400 mg -0-14-28-42 (December-February 2023). Severe side effects. The attending physician discontinued bevacizumab after 4 courses. In remission for 11 months. According to the results of the MRI dated April 28, 2024, continued growth. Neurological status is good. Reflexes are not impaired. To date, treatment options have been exhausted. Participation of the patient in Clinical Trials is impossible. As of April 2024, negative dynamics. The patient signed an informed consent agreement. Information on taking L-S-Gboxin (Lyophilisate) as part of a compassionate program - explained. Written consent of the attending physician for the patient's participation in the Compassion Program (TRIANGLE) with L-S-Gboxi (Lyophilisate) - received. (medical documentation will be available on clinicaltrials.gov within a month from the date of publication - patient's consent to publish the medical history and examination results has been obtained)

NCT ID: NCT06396481 Not yet recruiting - Medulloblastoma Clinical Trials

Clinical Study of Allogeneic Vγ9Vδ2 T Cells in the Treatment of Brain Malignant Glioma

CSA?dTBMG
Start date: April 30, 2024
Phase: Early Phase 1
Study type: Interventional

Primary brain malignant tumor has become the first lethal tumor in children and young adults, and the treatment is limited, and the prognosis of patients is poor. According to the classification of the World Health Organization, glioblastoma is divided into grade II, III and IV gliomas; The higher the degree of malignancy, the worse the clinical outcome. Among them, the most malignant, most lethal, and most common types of tumors include supratentorial glioblastoma, diffuse endopontine glioma (DIPG), medulloblastoma, and ependymoma. Its high malignancy is mainly manifested in three aspects: extremely rapid growth and obvious invasion; The operation is not easy to remove all; The tumor has a tendency of recurrence and disseminated implantation. It can occur with children and adults of all ages. At present, surgery combined with chemoradiotherapy is the main treatment, but the therapeutic effect is not good. Studies have shown that glioblastoma, as the most common primary brain malignant tumor in adults, after standard surgery, radiotherapy and chemotherapy, the median survival time is less than 15 months, and the overall five-year survival rate is only 5.4%. Even after receiving new and expensive Tumor-treating fields, the median survival time is less than 21 months. The median survival time of DIPG patients is generally less than 1 year, and the 5-year survival rate is less than 5%. The average 5-year survival rate of medulloblastoma and anaplastic ependymoma is 40%~60%. Innovative treatments are urgently needed. Immunotherapy based on Vγ9Vδ2 T cells has become a promising research direction in recent years. Its unique phosphine antigen recognition does not depend on major histocompatibility complex (MHC), easy to allograft and other advantages. Making it one of the most promising cell therapies. Brain glioma has abnormal cholesterol metabolism and phosphine antigen accumulation, which is easily sensed by Vγ9Vδ2 T cells. Therefore, the clinical exploration of Vγ9Vδ2 T cells for glioma is of great significance to both the scientific and clinical communities.

NCT ID: NCT06388733 Not yet recruiting - Glioblastoma Clinical Trials

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma

Start date: June 2024
Phase: Phase 3
Study type: Interventional

The goal of this Phase 3 clinical trial is to compare the efficacy of niraparib versus temozolomide (TMZ) in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma multiforme (GBM). The main questions it aims to answer are: Does niraparib improve progression-free survival (PFS) compared to TMZ? Does niraparib improve overall survival (OS) compared to TMZ? Participants will be randomly assigned to one of two treatment arms: niraparib or TMZ. - study drug (Niraparib) or - comparator drug (Temozolomide - which is the standard approved treatment for MGMT unmethylated glioblastoma). The study medication will be taken daily while receiving standard of care radiation therapy (RT) for 6-7 weeks. Participants may continue to take the niraparib or TMZ adjuvantly as long as the cancer does not get worse or completion of 6 cycles of treatment (TMZ). A total of 450 participants will be enrolled in the study. Participants' tasks will include: - Complete study visits as scheduled - Complete a diary to record study medication

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.

NCT ID: NCT06092255 Recruiting - GBM Clinical Trials

A Study of SVZ Irradiation With Postoperative Radiotherapy in Patients With GBM.

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

This phase I/II clinical trial is intended to investigate the efficacy and safety of SVZ irradiation with postoperative radiotherapy in patients with GBM.

NCT ID: NCT06039709 Recruiting - Clinical trials for Glioblastoma Multiforme

Sonodynamic Therapy in Patients With Recurrent GBM

GBM 001
Start date: January 31, 2024
Phase: Phase 1
Study type: Interventional

Patients diagnosed with glioblastoma (GBM) are faced with limited treatment options. This pilot study will evaluate the safety and feasibility of combining an investigational drug called 5-ALA with neuronavigation-guided low-intensity focused ultrasound (LIFU) for patients who have recurrent GBM. Focused ultrasound (FUS) can be used to non-invasively destroy tumor tissue while preserving normal tissue. When FUS is combined with 5-ALA, this combinatorial approach is called sonodynamic therapy (SDT), and this investigational therapy is being tested for its ability to cause damage to GBM cells. SDT will take place prior to surgery for recurrent GBM.

NCT ID: NCT05979064 Recruiting - Glioblastoma Clinical Trials

Omental Tissue Autograft in Human Recurrent Glioblastoma Multiforme (rGBM)

Start date: April 4, 2023
Phase: N/A
Study type: Interventional

This single center, single arm, open-label, phase I study will assess the safety of laparoscopically harvested autologous omentum, implanted into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.

NCT ID: NCT05973903 Not yet recruiting - GBM Clinical Trials

Lenvatinib, Pembrolizumab, and Tumor Treating Fields (TTFields) for Second-line Treatment of Glioblastoma

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

This will be a prospective, open label, single center, phase I lead-in study of 10 patients to a single arm phase-II study of 37 additional patients to assess the effectiveness of pembrolizumab and lenvatinib combination therapy for recurrent glioblastoma (rGBM) patients wearing TTFields electrodes.

NCT ID: NCT05954858 Recruiting - Glioblastoma Clinical Trials

Surgical Tissue Flap to Bypass the Blood Brain Barrier in Glioblastoma

Start date: June 29, 2023
Phase: N/A
Study type: Interventional

This single center, single arm, open-label, phase 2 study will assess the safety and efficacy of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multifome (GBM) patients. The objective of the Phase 2 study is to demonstrate that this surgical technique is safe and effective in a human cohort of patients with resected newly diagnosed AA or GBM and may improve progression-free survival (PFS) and overall survival (OS).

NCT ID: NCT05902169 Recruiting - Glioblastoma Clinical Trials

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM

SONOBIRD
Start date: January 29, 2024
Phase: Phase 3
Study type: Interventional

The brain is protected from any toxic or inflammatory molecule by the blood-brain barrier (BBB). This physical barrier is located at the level of the blood vessel walls. Because of these barrier properties, the blood vessels are also impermeable to the passage of therapeutic molecules from the blood to the brain. The development of effective treatments against glioblastoma is thus limited due to the BBB that prevents most drugs injected in the bloodstream from getting into brain tissue where the tumour is seated. The SonoCloud-9 (SC9) is an investigational device using ultrasound technology and specially developed to open the BBB in the area of and surrounding the tumour. The transient opening of the BBB allows more drugs to reach the brain tumour tissue. Carboplatin is a chemotherapy that is approved to treat different cancer types alone or in combination with other drugs, and has been used in the treatment of glioblastoma. Despite its proven efficacy in the laboratory on glioblastoma cells, carboplatin does not readily cross the BBB in humans. A clinical trial has shown that in combination with the SonoCloud-9, more carboplatin can reach the brain tumour tissue. The objective of the proposed trial is to show that the association - carboplatin with the SonoCloud-9 - will increase efficacy of the drug in patients with recurrent glioblastoma.