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Showing 1-20 of 54 trials
NCT05954858
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).
NCT05096481
This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51. Funding Source - FDA OOPD
NCT03340506
This study is to provide access for patients who are receiving treatment with dabrafenib and/or trametinib in a Novartis-sponsored Oncology Global Development, Global Medical Affairs or a former GSK-sponsored study who have fulfilled the requirements for the primary objective, and who are judged by the investigator as benefiting from continued treatment in the parent study as judged by the Investigator at the completion of the parent study.
NCT05278208
This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)
NCT07499141
During brain tumor surgery, it can be difficult for surgeons to distinguish between tumor tissue and healthy brain tissue. To address this challenge, fluorescent agents such as sodium fluorescein or 5-ALA are sometimes used. These substances cause the tumor to "glow" under specific lighting conditions, making it easier to visualize. This study retrospectively analyzes medical records of patients treated at the University Hospital of Alessandria between June 2023 and March 2024. It compares surgeries performed with these fluorescent agents to those performed without them, in order to determine whether fluorescence-guided surgery leads to a higher rate of complete tumor removal (gross total resection), as confirmed by post-operative MRI scans. The aim is to evaluate how the use of fluorescent dyes (fluorochromes) influences surgical outcomes in patients with high-grade gliomas (aggressive brain tumors). The study will also assess the impact of these tools on operative time, patient safety, and the overall recovery process.
NCT05212272
The purpose of this research study is to see if investigators can predict how brain functioning changes after radiation treatment based on PET scans and blood tests. Most participants experience at least mild decreases in their memory or attention after radiation therapy. Investigators hope that PET scans, lumbar puncture, and blood tests might help investigators predict who might have larger changes in their brain function after radiation.
NCT07416188
Background: Glioblastoma is a common brain cancer in adults. Treatment includes surgery, radiation, and chemotherapy. But this cancer can return after treatment and is often fatal. Researchers want to know if a study drug (LMP744) can kill glioblastoma tumor cells. Objective: To test LMP744 in people with glioblastoma. Eligibility: People aged 18 years or older with glioblastoma that returned after treatment. Design: Participants will be screened. They will have a surgery to remove a small sample of tumor tissue (biopsy) from the brain. This will be done under protocol 03-N-0164. They will stay in the clinic for 1 night. They will also have imaging scans and tests of their heart function. Participants will have a central line installed: A flexible tube will be inserted into a vein in the chest. It will be attached to a port under the skin. This port will be used to draw blood and give medicines without having to insert new needles into a vein. LMP744 will be given through the central line for 5 days in a row. Participants will remain in the clinic for this time. Participants will then have a second surgery to remove as much of their tumor as possible. They will remain in the clinic until they recover from the surgery. Then they will recover at home after surgery. Participants will return to the clinic to receive the study drug for 5 days in a row through the central line, once a month for up to 12 months. Blood tests, heart function tests, and periodic imaging scans will be repeated during these visits. Participants will continue to have telehealth visits every 3 months after they stop taking the drug.
NCT05839379
The goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.
NCT04655404
This is a pilot study that will evaluate disease status in children that have been newly diagnosed high-grade glioma with TRK fusion. The evaluation will occur after 2 cycles of the medication (Larotrectinib) have been given. The study will also evaluate the safety of larotrectinib when given with chemotherapy in your children; as well as the safety larotrectinib when given post-focal radiation therapy.
NCT07439172
Better treatments are needed for high-grade gliomas (HGG), and new ways of treating this disease should be tested. The investigators want to see if giving medicine before radiation works well. After radiation, MRI scans can be harder to understand because radiation changes how the brain looks on the scan. If new medicines are given before radiation, the scans are easier to read. First, the investigators need to find out if giving chemotherapy early works using a drug we already know can treat gliomas. The investigators will start with temozolomide, which is the only chemotherapy approved by the FDA for HGG. If this approach is successful, the investigators can then test new drugs using this screening method.
NCT04482933
This study is a clinical trial to assess the efficacy and confirm the safety of intratumoral inoculation of G207 (an experimental virus therapy) combined with a single 5 Gy dose of radiation in recurrent/progressive pediatric high-grade gliomas
NCT07042620
The objective of this clinical investigation is to assess the safety and performance of the SonoClear® System. 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 the SonoClear® System relative to routinely used acoustic coupling fluid is investigated by each patient being their own control. Patients with the diagnosis of high-grade glioma (HGG) and low-grade glioma (LGG) at up to 5 sites in Germany will be included. Additionally, safety data are collected at 72 hours, 30 days and 6 months post procedure.
NCT04201457
This phase I/II trial is designed to study the side effects, best dose and efficacy of adding hydroxychloroquine to dabrafenib and/or trametinib in children with low grade or high grade brain tumors previously treated with similar drugs that did not respond completely (progressive) or tumors that came back while receiving a similar agent (recurrent). Patients must also have specific genetic mutations including BRAF V600 mutations or BRAF fusion/duplication, with or without neurofibromatosis type 1. Neurofibromatosis type 1 is an inherited genetic condition that causes tumors to grow on nerve tissue. Hydroxychloroquine, works in different ways to stop the growth of tumor cells by killing the cells or stopping them from dividing. Trametinib and dabrafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving hydroxychloroquine with trametinib and/or dabrafenib may lower the chance of brain tumors growing or spreading compared to usual treatments.
NCT02473380
Intraoperative surgical fluorescence microscopy is a useful technique for the surgical resection of glioma. However the accuracy of this method is limited by its too low sensitivity. Fluorescence spectroscopy has the potential capacity to overcome the current limitations of conventional fluorescence guided surgery by increasing the sensitivity: in a pilot study on brain tumor biopsies, fluorescence spectroscopy was shown to measure two-peaked 5-ALA-induced protoporphyrin IX (PpIX) fluorescence emission spectrum which clearly enables to distinguish the solid component of glioblastomas from low grade gliomas and infiltrative component of glioblastomas. This innovative method could become in future a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. However, those preliminary ex-vivo results have to be confirmed in a feasibility in-vivo study on human.
NCT04209790
Preoperative therapy has not been well studied in resectable glioblastoma. This study attempts to prospectively assess the feasibility and efficacy of preoperative chemo radiation in improving local control, as this is the predominant mode of failure in these patients leading to poor outcomes. This Phase II study design would be used to proceed with the study treatment after meeting pre-specified events in the initial phase, with goal being to determine whether the new treatment paradigm is sufficiently promising to warrant a major controlled clinical evaluation against the standard therapy.
NCT03561870
Recent data demonstrate that in IDH-mutant gliomas, 2 hydroxy-glutarate production induces a homologous recombination defect that renders tumor cells exquisitely sensitive to poly(adenosine 5'-diphosphate-ribose) polymerase (PARP) inhibitors, including olaparib (Lynparza; AstraZeneca). The aim of this open-label phase 2 study is to evaluate the efficacy of olaparib in in recurrent IDH-mutant high grade gliomas based on 6 months progression-free survival.
NCT05375318
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.
NCT06428045
The purpose of this study is to determine whether newly diagnosed high-grade glioma(s) that cannot be removed surgically change as a result of the study treatment; and to identify and evaluate the potential side effects (good and bad) of the study treatment in patients with newly diagnosed high-grade glioma(s) that cannot be removed surgically.
NCT02970448
The investigators of this study want to see if shortening the total treatment time for brain tumors is safe.The treatment for participant's brain tumors is laser surgery (Laser Interstitial Thermal Therapy (LITT)) followed by radiation with chemotherapy. For participants, the total time of treatment from surgery to the end of radiation and chemotherapy is about l 0 weeks long. This study asks whether it is safe to shorten the total treatment to 7 weeks. To shorten the total treatment time, investigators want to see if it is safe to start radiation with chemotherapy within 5 days after surgery. Usually patients start their radiation with chemotherapy about 21-28 days after the surgery. Shortening the total time of treatment may allow investigators to kill the cancer cells more effectively.
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.