View clinical trials related to Glioblastoma, IDH-wildtype.
Filter by:This multi-site, Phase 1/2 clinical trial is an open-label study to identify the safety, pharmacokinetics, and efficacy of a repeated dose regimen of NEO212 for the treatment of patients with radiographically-confirmed progression of Astrocytoma IDH-mutant, Glioblastoma IDH-wildtype, and the safety, pharmacokinetics and efficacy of a repeated dose regimen of NEO212 when given with select SOC for the treatment of solid tumor patients with radiographically confirmed uncontrolled brain metastasis. The study will have three phases, Phase 1, Phase 2a and Phase 2b.
The study aims at: 1. Perform a multilayer analysis relying on tight integration of in-depth multi-omics approaches with clinical data to discover immune markers, with attention to age and sex differences, predicting prognosis and defining key life/environmental elements, to guide AI-driven personalised treatments and ensure improved care and QoL of glioblastoma patients. 2. To deepen glioblastoma knowledge through the study of glioblastoma stem cell cultures and to assess the sensitivity of glioblastoma stem cell cultures to a number of chemotherapeutics in different experimental conditions. 3. To create a comprehensive, stakeholder-generated guidelines for the ethical use of patient data for artificial intelligence-assisted prediction systems in glioblastoma, including an online, easily accessible patient information brochure to increase patient empowerment in the field.
About 75% of CNS malignant tumors are classified as gliomas and the IDH-wildtype glioblastoma (GBM) represents the most aggressive form among CNS malignancies. This is a nationwide single-center phase II drug clinical trial with an approximate duration of 32 months. The clinical trial will be single-arm to evaluate the biological activity and effects of metformin in combination with TMZ in patients with GBM.
The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.
This phase II trial tests how well the combination of WP1066 and radiation therapy works in treating newly diagnosed glioblastoma. Glioblastoma is difficult to treat effectively because the cells within the tumor vary widely and are controlled by factors within and around the tumor, requiring multiple approaches to treat the tumor. The study drug WP1066 targets a specific pathway, known as STAT3, which is responsible for promoting tumor growth and causing the body's immune system to avoid attacking the tumor. Radiation therapy prevents glioblastoma from growing. Giving WP1066 with radiation therapy may prevent glioblastoma from growing and prolong survival.
The goal of this phase II randomized clinical trial is to compare the safety and efficacy of Elemene plus Stupp Protocol (the new protocol) and Stupp Protocol alone (the standard protocol) in patients with newly-diagnosed glioblastomas (ndGBMs). The main questions to answer are: - Whether the new treatment protocol (Elemene plus Stupp Protocol) is clinically safe for ndGBM patients. - Whether the new treatment protocol (Elemene plus Stupp Protocol) brings better survival benefits for ndGBM patients compared to the standard-of-care Stupp Protocol. Study participants will be enrolled in 5 hospitals in China and randomly assigned to receive either the new protocol or the standard protocol. The overall survival (OS) rate in the 12th month, the progression-free survival (PFS) rate in the 6th month, OS, PFS, and adverse events assessed by the CTCAE (Common Terminology Criteria for Adverse Events) will be evaluated for all patients.
The study envisages NGS analysis on tumor tissue from patients treated with regorafenib for recurrent glioblastoma as per standard care, with the aim to identify predictive biomarkers for response.
The main purposes of this study are: I. To assess that the four habitats within the tumor (HAT and LAT) and edema (IPE and VPE) in high-grade glioma are different at vascular, tissular, cellular and molecular levels. II. To analyze the associations between the perfusion imaging markers and relevant molecular markers at the HTS habitats for high-grade glioma diagnosis, prognosis/aggressiveness, progression and/or prediction. III. To analyze the associations between the perfusion imaging markers and immune markers at the HTS habitats useful in immunotherapy evaluation and/or patient selection. IV. To prospectively validate the prognostic capacity (association with OS and PFS) and stratification capacity of the perfusion imaging markers calculated at the HTS habitats.
This is a pilot or feasibility study to test the study plan and to find out whether enough participants will join a larger study and accept the study procedures. Eligible participants (adults with newly diagnosed glioblastoma multiforme [GBM] and had a good tumour resection [>= 70% of initial tumour volume] and plan to receive 6 weeks of chemoradiation followed by up to 6 months of chemotherapy) are asked to donate their own stool samples at 4 different time points during their treatment course. Participants will also complete a 7-day diet diary and two questionnaires about their health-related quality of life. Glioblastoma multiforme (GBM) is the most common and aggressive form of primary brain cancer in adults. The current best evidence-proven treatment for GBM includes maximum safe tumour resection, brain radiation over a 6-week period given with chemotherapy pills called temozolomide (Brand name: Temodal or Temodar), followed by approximately 6 months / cycles of temozolomide. Despite these treatments, the average life expectancy is generally less than 2 years. Researchers are recognizing that the immune system has an important role in directing the effectiveness of chemotherapy, radiation, and newer therapies such as immunotherapies. Some immunotherapies have been quite successful in improving cancer control and survival in other cancers like melanoma (an aggressive skin cancer), but when these drugs were given to patients with GBM, there appeared to only be a small effect. Therefore, finding ways to make existing and new treatments work better should be a priority. Recent scientific studies have shown that the bacteria that make up our stool, often referred to as the gut microbiome, play a major role in regulating the immune system. For example, researchers were able to make patients with melanoma who previously did not respond to immunotherapy become responsive to the treatment after receiving a stool transplant from responders to immunotherapy. This provides proof of concept that we could modify the body's immune environment to favour cancer killing by changing a person's gut bacteria environment. The role of the gut bacteria in patients with brain cancer is poorly understood as very few studies have been published about it in this population. We believe that understanding the composition of the gut microbiome and how it relates to the effectiveness and side effects of treatments in GBM patients will be an important first step to understanding how we can modify the gut microbiome to improve outcomes for patients living with GBM.
Primary brain cancer kills up to 10,000 Americans a year. These brain tumors are typically treated by surgery, radiation therapy and chemotherapy, either individually or in combination. Present therapies are inadequate, as evidenced by the low 5-year survival rate for brain cancer patients, with median survival at approximately 12 months. Glioma is the most common form of primary brain cancer, afflicting approximately 7,000 patients in the United States each year. These highly malignant cancers remain a significant unmet clinical need in oncology. The investigators have completed a Phase I clinical trial that has shown that Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (BV) is safe up to a dose of 15mg/kg in patients with recurrent malignant glioma. Additionally, the investigators have shown in a recently completed Phase I/II clinical trial, that SIACI BV improves the median progression free survival (PFS) from 4-6 months to 11.5 months and overall survival (OS) from 12-15 months to 23 months in patients with newly diagnosed GBM. Therefore, this two-arm, randomized trial (2:1) is a follow up study to these trials and will ask simple questions: Will this repeated SIACI treatment regimen increase progression free survival (PFS-primary endpoint) and overall survival (OS-secondary endpoint) when compared with standard of care in patients with newly diagnosed GBM? Exploratory endpoints will include adverse events and safety analysis as well as quality of life (QOL) assessments. The investigators expect that this project will provide important information regarding the utility of repeated SIACI BV therapy for newly diagnosed GBM and may alter the way these drugs are delivered to our patients in the near future.