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Glioblastoma clinical trials

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NCT ID: NCT06368934 Not yet recruiting - Glioblastoma Clinical Trials

Sub-lobectomy for IDH Wild-type and TERT Promoter Mutant Glioblastoma

Start date: April 8, 2024
Phase: N/A
Study type: Interventional

Glioblastoma is recognized as the most common and aggressive form of primary malignant brain tumor, with treatment options that are limited and prognosis that is extremely poor, showing median progression-free survival of 12 months and median overall survival of less than 18 months. Surgical resection plays a critical role in the treatment, with the extent of resection significantly impacting patient outcomes. Historical approaches to surgical resection have evolved, moving from radical strategies to more conservative ones that aim to preserve normal brain function while removing the tumor as completely as possible. Recent studies have suggested that increasing the extent of surgical resection, particularly along the T2 FLAIR border rather than the traditional T1-enhanced border, can significantly improve patient prognosis. There is, however, a lack of consensus on the optimal surgical approach, and the heterogeneity of tumors presents challenges in standardizing surgical strategies. Extended resection has been shown to prolong survival, and novel intraoperative molecular diagnostics have emerged to improve accuracy in tumor classification and prognosis. Building on these advancements, a multicenter, prospective, randomized controlled trial is proposed to evaluate the efficacy of sub-lobectomy in treating IDH wild-type/TERTp-mutant glioblastoma, aiming to improve evidence levels and establish standardized surgical practices for this devastating disease.

NCT ID: NCT06359379 Not yet recruiting - Clinical trials for Glioblastoma, IDH-wildtype

Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter

Start date: June 2024
Phase: Phase 2
Study type: Interventional

This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy.

NCT ID: NCT06356883 Recruiting - Clinical trials for Glioblastoma Multiforme

Intraarterial Carboplatin + Caelyx Compared to Intraarterial Carboplatin + Etoposide Phosphate for Progressing Glioblastoma

Start date: April 2024
Phase: Phase 2
Study type: Interventional

The standard of care for glioblastoma (GBM) treatment involves maximal resection followed by concomitant radiotherapy and temozolomide. Progression-free survival (PFS) with this treatment is only 6.9 months and relapse is inevitable. At relapse, there is no consensus regarding the optimal therapeutic strategy. The rationale behind the fact that limited chemotherapy agents are available in the treatment of malignant gliomas is related to the blood-brain barrier (BBB), which impedes drug entry to the brain. Intraarterial (IA) chemotherapy allows to circumvent this. Using IA delivery of carboplatin, can produce responses in 70% of patients for a median PFS of 5 months. Median survival from study entry was 11 months, whereas the overall survival (OS) 23 months. How can the OS and PFS be improved? By combining chemotherapeutic agents with different mechanisms of action. Study design: In this phase II trial, treatment will be offered at relapse. Surgery will be performed for cytoreduction if it is warranted, followed with a combination IA carboplatin + IA Cealyx (liposomal doxorubicin) or IA carboplatin + IA etoposide phosphate. Toxicity will be assessed according to the NCIC common toxicity criteria. Treatment will consist in either IA carboplatin (400 mg/m^2) + IA Cealyx (30 mg/m^2) or IA carboplatin (400 mg/m^2) + IA etoposide phosphate (400 mg/m^2) every 4-6 weeks (1 cycle). Up to twelve cycles will be offered. Outcome measurements: Tumor response will be evaluated using the RANO criteria by magnetic resonance imaging monthly. Primary outcome will PFS and tumor response. Secondary outcome will include median OS, toxicity, quality of life (QOL), neurocognition (NC). Putting together these data will allow to correlate clinical and radiological response to QOL and NC.

NCT ID: NCT06353360 Not yet recruiting - Clinical trials for Glioblastoma Multiforme

TTField in Combination With TMZ and Tislelizumab in The Treatment of Newly Diagnosed Glioblastoma.

Start date: April 5, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical trial is To investigate the safety and efficacy of Tumor-Treating Fields (TTFields) in combined with temozolomide (TMZ) and tislelizumab in the treatment of newly diagnosed glioblastoma (GBM).

NCT ID: NCT06348693 Recruiting - Glioblastoma Clinical Trials

Development of Therapeutic Approaches Modulating Molecular Targets Implicated on Cancer Stem Cell-related Aggressiveness

Start date: April 19, 2017
Phase:
Study type: Observational

Tumors of the central nervous system affect 21 people per 100,000 every year, a figure that refers to countries with advanced economies, with an increase in incidence over time. Experimental evidence suggests that cancer stem cells (CSCs) may play a key role in the malignancy of these tumors. In fact, due to the hypoxic tumor microenvironment, these cells are able to create compensatory pathways that confer stem-like, angiogenic and pro-tumoral functions. Furthermore, it has been demonstrated that brain tumor stem cells are radio- and chemo-resistant and therefore not treatable with the therapeutic protocols currently in use. To date, in fact, there are no definitive treatments for the eradication of brain tumors. In this scenario, sphingolips, a class of lipid deputized to several physiological functions, are also involved in tumor onset, progression, drug resistance, and aggressiveness. In hypoxic tumor microenvironment, CSCs present a modified rheostat in the metabolism of sphingolipid, in favor of Sphingosine-1-phosphate (S1P). S1P is an intermediate of sphingolipid metabolism, formed from sphingosine through the action of sphingosine kinases (SK). Increasing evidence suggests that S1P acts as a tumor-promoting signal, predominantly in the extracellular environment, regulating important cellular properties correlated with tumor potential. The project aims to identify new molecular and metabolic targets involved in the survival and chemo-resistance of tumor stem cells in relation to the tumor microenvironment.

NCT ID: NCT06346821 Recruiting - Clinical trials for Glioblastoma Multiforme

Tumor Treating Fields for Newly Diagnosed Glioblastoma: Two Emulated Trials With Chinese Multi-Hospital Based Real-World Data

Start date: July 4, 2023
Phase:
Study type: Observational [Patient Registry]

The goal of this observational study is to learn about the effectiveness of Optune® (Tumor Treating Fields) in newly diagnosed glioblastoma (GBM) in China. The main question it aims to answer are: - The efficacy of Optune® as an concomitant/adjuvant to radiation therapy (RT) and temozolomide (TMZ) alone in the treatment of newly diagnosed GBM patients. - The effectiveness of Optune® given concomitantly with RT and TMZ in newly diagnosed GBM patients, compared to RT and TMZ alone. Participants will: - Receive or not receive TTFields. - Concomitantly or adjuvantly receive TTFields.

NCT ID: NCT06344130 Not yet recruiting - Glioma Clinical Trials

Hypofractionation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma

Start date: April 21, 2024
Phase: Phase 1
Study type: Interventional

Background: Glioblastoma (GBM) is a cancer of the brain. Current survival rates for people with GBM are poor; survival ranges from 5.2 months to 39 months. Most tumors come back within months or years after treatment, and when they do, they are worse: Overall survival drops to less than 10 months. No standard treatment exists for people whose GBM has returned after radiation therapy. Objective: To find a safe schedule for using radiation to treat GBM tumors that returned after initial radiation treatment. Eligibility: People aged 18 years and older with grade 4 GBM that returned after initial radiation treatment. Design: Participants will be screened. They will have a physical exam with blood tests. A sample of tumor tissue may be collected. Participants will undergo re-irradiation planning: They will wear a plastic mask over their head during imaging scans. These scans will pinpoint the exact location of the tumor. This spot will be the target of the radiation treatments. Participants will undergo radiation treatment 4 times per week. Some people will have this treatment for 3 weeks, some for 2 weeks, and some for 1 week. Blood tests and other exams will be repeated at each visit. Participants will complete questionnaires about their physical and mental health. They will answer these questions before starting radiation treatment; once a week during treatment; and at intervals for up to 3 years after treatment ends. Participants will have follow-up visits 1 month after treatment and then every 2 months for 6 months. Follow-up clinic visits will continue up to 3 years. Follow-ups by phone or email will continue an additional 2 years.

NCT ID: NCT06336291 Not yet recruiting - Glioblastoma Clinical Trials

A Study With L19TNF in Combination With Lomustine in Patients With Glioblastoma at Progression or Recurrence

GLIOSTELLA
Start date: June 2024
Phase: Phase 2
Study type: Interventional

The trial aims to collect safety, efficacy, exposure, dose- response, pharmacokinetic and pharmacodynamic information of the combination of L19TNF and lomustine at different dose levels in patients with Glioblastoma at progression or recurrence

NCT ID: NCT06333899 Not yet recruiting - Glioblastoma Clinical Trials

Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion

Start date: September 1, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this study is to determine the response of the study drug loratinib in treating children who are newly diagnosed high-grade glioma with a fusion in ALK or ROS1. It will also evaluate the safety of lorlatinib when given with chemotherapy or after radiation therapy.

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.