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NCT07441707
The purpose of this study is to evaluate safety and the way the body absorbs, distributes and gets rid of the study drug tovorafenib in the body in Japanese children, adolescents and young adults with specific brain tumours. This includes how the drug is absorbed, distributed and eliminated from the body (called pharmacokinetics). The study will also test how well the drug works to shrink brain tumours. In this study, all participants will receive tovorafenib orally once weekly. There will be four periods in this study: 1. Screening period (up to 4 weeks): Participants will be evaluated to determine if they can take part in the study, requiring at least one visit to the study centre. 2. Treatment period (up to 24 months): All eligible participants will receive tovorafenib. This requires five visits for the first 2 months (Cycle 1 and Cycle 2) followed by one visit every month (at the start of each treatment cycle). Participants will receive the first oral dose of tovorafenib on Day 1 of Cycle 1 at the study clinic. After Day 1, participants will need to take tovorafenib once weekly on Day 8, Day 15 and Day 22. Participants will be required to come to the study clinic in person at least five times for Cycle 1 and Cycle 2. In addition, participants will have one remote visit (telephone call) during Cycle 1. After Cycle 2, only one in-person clinic visit is required at the start of each treatment cycle. A participant will stop treatment if their disease gets worse, if treatment has a harmful effect, or if they do not want to take part in the study anymore. 3. End-of-Treatment Safety Follow-Up (30 days): Participants will have a clinic visit 30 days after stopping treatment to check their health. 4. Long-Term Follow-Up (up to 2 years): Participants will be monitored every 3 months unless they start a new anti-cancer treatment or leave the study. During the study, participants will undergo various health measurements and observations, including blood sampling and urine collections. Each participant will be in this study for up to approximately 4 years. Tovorafenib will be provided to participants who tolerate it for as long as their disease does not progress. Once tovorafenib becomes approved and commercially available in Japan, participants may transition to the commercial drug for continued treatment. A participant may withdraw consent to participate at any time.
NCT03429803
This research study is studying a drug Tovorafenib/DAY101 (formerly TAK-580, MLN2480) as a possible treatment a low-grade glioma that has not responded to other treatments. The name of the study drug involved in this study is: • Tovorafenib/DAY101 (formerly TAK-580, MLN2480)
NCT05406700
This is a randomized, two-arm, open-label, phase 0 trial to assess intratumoral pharmacokinetics and pharmacodynamics of niraparib in subjects with progressive IDH1 or IDH2 mutant glioma. \- This research study involves an experimental treatment called Niraparib.
NCT01734512
This is an open label study of everolimus in children with recurrent or progressive low-grade glioma.
NCT04734444
The objective of this clinical investigation is to assess the safety and performance of the SonoClear Acoustic Coupling Fluid (ACF). The performance will be assessed by analysis of the contrast-to-noise ratio (CNR) and assessment of image quality by using the Surgeon Image Rating (SIR) Scale. This is a prospective, multi-centre single-arm study where the performance of SonoClear ACF relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of HGG and LGG at up to 10 sites will be included. Additionally, safety data are collected at 30 days and 6 months post-procedure.
NCT06381570
This is a Pilot, multicenter, open-label study of patients less than or equal to 25 years, with recurrent or progressive LGG harboring a CRAF or BRAF alteration, including BRAF V600 mutations and KIAA1549: BRAF fusions. Patients with BRAF or CRAF alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories. The study will be conducted in two sequential phases: Phase A: A Feasibility (combination dose finding) phase, followed by Phase B: An Efficacy phase. The maximum tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) of the combination as determined in Phase A would be the dose used in Phase B. The patients on Phase A who were below the MTD/RP2D would be eligible for intra-patient dose escalation to MTD/RP2D subject to criteria outlined later
NCT06610851
With around 3,400 cases per year in France, diffuse gliomas are the most common primary tumours of the central nervous system. Their grade varies from 2 to 4. Whatever the grade, their prognosis is poor, because tumour recurrence is systematic, because no personalised medicine is available for the treatment of these cancers, and because the tools for monitoring recurrence are imperfect. Treatment of diffuse gliomas is based on removal of as much of the tumour as possible, whatever its grade. Surgery is followed by radiotherapy and chemotherapy depending on the grade and quality of the excision. In the event of recurrence, the patient may be offered second-line chemotherapy or further surgery. During and after treatment, patients are regularly monitored by MRI in order to detect any recurrence as early as possible and propose a new treatment. However, for grade 2 and 3 gliomas, MRI monitoring is imperfect because it cannot detect tumour recurrence at an early stage. Initiation of new treatment at the time of recurrence, which is inevitable, is therefore often delayed, which is harmful for patients. It is therefore vital to identify a reliable, easy-to-use and non-invasive biomarker that can be used to monitor patients undergoing surgery for grade 2 and 3 diffuse gliomas, and thus enable earlier diagnosis of recurrence. These biomarkers could be microRNAs. MicroRNAs are small non-coding RNAs involved in the regulation of genes and, consequently, of the intracellular signalling pathways that govern cell behaviour. They are therefore widely implicated in oncogenesis, and in particular in the mechanisms that promote tumour migration, invasion and proliferation. Several preliminary studies have shown that serum levels of pro-oncogenic microRNAs correlate with tumour rates in gliomas. No study has investigated the possibility of using them to detect tumour recurrence earlier in grade 2 and 3 gliomas. With this study, the investigators hope to use pro-oncogenic microRNAs to monitor glioma patients and diagnose early recurrence in grade 2 and 3 gliomas.
NCT05873946
This retrospective study aims to assess the utility of 2D non-navigated intraoperative ultrasound (ioUS) as a cost-effective alternative for guiding the surgical resection of gliomas and for detecting residual tumor. The study will analyse the records from consecutive adult patients diagnosed with gliomas, undergoing craniotomy between June 2018 and June 2023. The extent of resection (EOR) will be determined using postoperative MRI as the gold standard. The study will also examine the sensitivity and specificity of ioUS in detecting residual tumor. This research seeks to determine if ioUS can be an affordable and reliable tool that, combined with other intraoperative adjuncts, may aid neurosurgeons in achieving the maximum safe resection in glioma surgery.
NCT05233215
This research study is being done to test a participant and caregiver-driven model of follow-up survivorship care,GROW Support (Glioma Specialists Reaching Out With Support), for post-treatment, low grade glioma patients.
NCT04346472
Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment
NCT04316039
It has been reported that radiation therapy followed by PCV chemotherapy (procarbazine, lomustine and vincristine) could improve progression-free survival (PFS) and overall survival (OS) in patients with high-risk WHO grade 2 gliomas after surgery. However, procarbazine is not available in China. In clinical practice, Chinese doctors often use radiotherapy combined with temozolomide to treat these patients, though large-scale prospective studies are lacking. This trial aims to confirm whether RT combined with temozolomide can improve PFS and OS in patients with high-risk low-grade gliomas.
NCT00782626
The purpose of this research study is to learn if the study drug RAD001 can shrink or slow the growth of low-grade gliomas. Additionally, the safety of RAD001 will be studied. RAD001 is a drug that may act directly on tumor cells by inhibiting tumor cell growth and proliferation.