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85 active trials for Brain Tumor

Metabolic Characterization of Space Occupying Lesions of the Brain

High field MR-technologies are expected to boost metabolic spectroscopic imaging (MRSI), but also CEST-MRI. This is due to the fact that increased SNR is available which can be used to increase the spatial resolution of all sequences, or reduction of measurement times. Recent findings has shown that MRSI can be used to evaluate the isocitrate dehydrogenase (IDH) status of gliomas, a brain tumor type which is most often diagnosed in humans. Patients with IDH-mutated gliomas have a much longer survival time that IDH-wildtype. In IDH-mutated gliomas the substance 2-hydroxy-glutarate (2HG) is found, whereas in IDH-wildtype gliomas it is not. The underlying trial aims to measure 2HG directly with different MRSI sequences at 3 Tesla (3T) and 7 Tesla (7T) magnetic field strength. Apart from MRSI-techniques for IDH-typing it has been shown that CEST-imaging can also be performed to determine the IDH-status of gliomas. A total of 75 patients and 50 healthy controls will be examined in this study to evaluate the most accurate method for pre-operative IDH-status determination.

Start: September 2021

Trial of CUDC-907 in Children and Young Adults With Relapsed or Refractory Solid Tumors, CNS Tumors, or Lymphoma

This research study is evaluating a novel drug called CUDC-907 as a possible treatment for resistant (refractory) pediatric solid tumors (including neuroblastoma), lymphoma, or brain tumors.

Start: October 2016

Tumor Treating Fields With Chemoradiation in Newly Diagnosed GBM

The study is an open-label pilot study in newly diagnosed glioblastoma patients following surgery. Eligible patients will receive treatment with tumor treating fields therapy using the Optune device starting less than 2 weeks prior to start of chemoradiation. Patients will receive radiation and temozolomide at a routine treatment dose and schedule.

Start: December 2019

Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors

Tumor infiltration lymphocytes (TILs) have been harvested from advanced cancer patients and constructed to knockout PD1 gene and express scFvs against both PD1 and CTALA4 and CARs against various antigens, followed by transfusion into the patients. The safety, tolerance, and preliminary clinical efficacy of the TILs will be evaluated.

Start: January 2021

Utility of Primary Glioblastoma Cell Lines

In this study, the characterization of human malignant glioma cell lines is described. After mechanical and enzymatic digestion of glioblastoma human biopsies from Neuromed IRCCS Neurosurgery patients, the investigators analyzed the established cell lines by immunohistochemistry. The investigators have already characterized 10 cell lines and results revealed that not all cell lines are positive for glial fibrillary acidic protein (GFAP), but only one was positive: the so-called COGI cell line. Moreover, the expression of Isocitrate Dehydrogenase 1(IDH1) and alpha thalassemia/mental retardation syndrome X-linked protein (ATRX) was investigated in all established cell lines. COGI cell line was also positive for IDH1R132 mutation and for ATRX. The results of characterization were summarized in table 1.

Start: June 2019

Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases

Dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) is a potentially powerful diagnostic tool for the management of brain cancer and other conditions in which the blood-brain barrier is compromised. This trial studies how well precise DCE MRI works in diagnosing participants with high grade glioma that has come back or melanoma that has spread to the brain. The specially-tailored acquisition and reconstruction (STAR) DCE MRI could provide improved assessment of brain tumor status and response to therapy.

Start: July 2021

LITT Followed by Hypofractionated RT for Newly Diagnosed Gliomas (GCC 20138)

The purpose of this study is to evaluate the treatment regimen of using Laser Interstitial Thermal Therapy (LITT) and Hypo-fractionated Radiation Therapy to treat patients with newly diagnosed gliomas.

Start: February 2021

The Registry of Oncology Outcomes Associated With Testing and Treatment

This study is to collect and validate regulatory-grade real-world data (RWD) in oncology using the novel, Master Observational Trial construct. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.

Start: April 2021

IDH1 Peptide Vaccine for Recurrent Grade II Glioma

Potential subjects with progressive Grade II primary brain tumor that have IDH1 positive testing from the primary tumor (initial diagnosis) will be offered this treatment study in order to test the safety of the PEPIDH1M vaccine in combination with standard chemotherapy (temozolomide).

Start: January 2016

Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy

Background: Neurobehavioral functions and quality of life (QoL) are the important outcome measurements after radiotherapy in patients with brain tumors and even head/neck cancers. However, few studies have focused on neurobehavioral functions and QoL after anti-cancer treatment particularly brain radiotherapy for pediatric/adolescent patients with brain tumors. This study thus aims to prospectively evaluate those functions in pediatric or adolescent patients with brain or head/neck tumors in order to provide useful information about their clinical outcomes. Methods: A total of 72 pediatric/adolescent patients, who are diagnosed with brain tumors or head/neck cancers, were prospectively recruited. Neurobehavioral functions will be evaluated using a neuropsychological battery, which includes general cognitive functions, intelligence, memory, executive functions, information processing and emotional/behavioral expressions. The QoL will be evaluated by the health-related QoL questionnaire. All participants will be examined at six phases, which include pre-treatment, 1-month post-treatment, 4-month post-treatment, 1-year post-treatment, 2-year post-treatment and 3-year post-treatment. Expected results: Patients'neurobehavioral functions and QoL will show significant improvement after treatment, and the improvement will not be diminished across each post-treatment phase.

Start: September 2013

Perioperative Evaluation of Cerebellar Tumors

This is a prospective, cohort study to evaluate the impact of cerebellar functional topography on perioperative outcomes related to cognition and motor ataxia in patients with cerebellar tumors.

Start: February 2021

Repeated Super-Selective Intraarterial Cerebral Infusion of Bevacizumab (Avastin) for Treatment of Newly Diagnosed GBM

The high-grade malignant brain tumors, glioblastoma multiforme (GBM), comprise the majority of all primary brain tumors in adults. This group of tumors also exhibits the most aggressive behavior, resulting in median overall survival of only 9-12 months. Initial therapy consists of either surgical resection, external beam radiation, or both. All patients experience a recurrence after first-line therapy, so improvements in both first-line and salvage therapy are critical to enhancing quality-of-life and prolonging survival. It is unknown if currently used intravenous (IV) therapies even cross the blood brain barrier (BBB). We have shown in a previous phase I trial that a single Superselective Intraarterial Cerebral Infusion (SIACI) of Bevacizumab (up to 15mg/kg) is safe and effective in the treatment of recurrent GBM. Therefore, this phase I/II clinical research trial is an extension of that trial in that we seek to test the hypothesis that repeated dosing of intra-arterial Bevacizumab is safe and effective in the treatment of newly diagnosed malignant glioma. By achieving the aims of this study we will also determine if repeated intra-arterial Bevacizumab improves progression free and overall survival in newly diagnosed patients. We expect that this project will provide important information regarding the utility of repeated SIACI Bevacizumab therapy for malignant glioma, and may alter the way these drugs are delivered to our patients in the near future.

Start: February 2013

Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM

The purpose of this study is to evaluate the safety and efficacy of administering the medication capecitabine along with temozolomide when you start your monthly regimen of oral temozolomide for the treatment of your newly diagnosed glioblastoma multiforme (GBM). Capecitabine is an oral chemotherapy that is given to patients with other types of cancer. The study will evaluate whether the dosage of 1500 mg/m2 of capecitabine is tolerable after radiation, when taken along with temozolomide. It will also try to determine if the medication capecitabine helps patients respond to treatment for a longer period of time compared to just temozolomide alone, which is the standard of care.

Start: June 2017

SGM-101 in Colorectal Brain Metastases.

This study assesses the feasibility of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody, for intraoperative near-infrared fluorescence imaging of colorectal brain metastases by injecting SGM-101 intravenously 3 - 5 days prior to surgery.

Start: April 2021

18F-DOPA II - PET Imaging Optimization

A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations: Pediatric patients (less than 18 years old) with congenital hyperinsulinism. Pediatric patients (less than 18 years old) with neuroblastoma. Pediatric (less than 18 years old) or Adult patients (18 or older) with known or clinically suspected neuroendocrine tumor. Adult patients (18 or older) with a clinical suspicion of Parkinson's disease or Lewy body dementia. Pediatric (less than 18 years old) or Adult patients (18 or older) with brain tumors. Image optimization (the primary study objective) and gallbladder activity pattern (the secondary objective) will be evaluated.

Start: January 2021

A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade Gliomas

This project is being done to induce remapping of functional cortex in patients with invasive gliomas to enable a greater extent of resection of invasive gliomas while minimizing the risk of a permanent neurological deficit. Adult diffuse gliomas, or the type of gliomas that are being targeted in this study, are not generally curable by surgery; however, life expectancy is generally believed to be increased by resecting more of the tumor. Because surgeons cannot resect all the tumor when it invades certain parts of the brain that are primarily responsible for language or movement, the investigators are attempting to see if they can electrically inactivate those parts of the brain with tumor in it so it can be resected in a subsequent surgery.

Start: January 2022

Handheld Dynamometer During Awake Craniotomy Pilot

The primary purpose of this study is to assess the feasibility, safety and reliability of the use of handheld dynamometry in evaluating intraoperative motor function for patients undergoing awake craniotomy for the resection of brain lesions located within or adjacent to the motor cortex.

Start: July 2020

A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma

The main purpose of this study is to find out the highest possible dose of maprotiline that can be given safely in combination with temozolomide and tamoxifen.

Start: May 2021

CSF Biomarkers for Brain Tumors

The purpose of this study is to generate a biorepository of Cerebrospinal Fluid (CSF) samples relevant to patients with brain tumors. These samples may facilitate the identification of biomarkers predictive of disease burden, therapeutic susceptibility or response to therapy.

Start: January 2021

Ommaya Reservoir Placement for Brain Tumor Biomarker Access

The purpose of this study is to determine the safety and feasibility of intra-operative Ommaya Reservoir placement during a clinically indicated operation for brain tumor. The Ommaya reservoir will facilitate a longitudinal access to cerebrospinal fluid (CSF) for analysis of potential biomarkers for brain tumor research and individualized monitoring.

Start: January 2021