Clinical Research Directory

A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations

Background: Diffuse gliomas are tumors that affect the brain and spinal cord. Gliomas that develop in people with certain gene mutations (IDH1 or IDH2) are especially aggressive. Better treatments are needed. Objective: To see if a study drug (zotiraciclib) is effective in people with recurrent diffuse gliomas who have IDH1 or IDH2 mutations. Eligibility: People aged 15 years and older with diffuse gliomas that returned after treatment. They must also have mutations in the IDH1 or IDH2 genes. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of their heart function. They will have an MRI of their brain. A new biopsy may be needed if previous results are not available. Zotiraciclib is a capsule taken by mouth with a glass of water. Participants will take the drug at home on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. They may also be given medications to prevent side effects of the study drug. The schedule for taking the study drug may vary for participants who will undergo surgery. Participants will be given a medication diary for each cycle. They will write down the date and time of each dose of the study drug. Participants will visit the clinic about once a month. They will have a physical exam, blood tests, and tests to evaluate their heart function. An MRI of the brain will be repeated every 8 weeks. Participants may remain in the study for up to 18 cycles (1.5 years).

LITT Followed by Hypofractionated RT for Recurrent Gliomas

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 recurrent gliomas.

Natural History of and Specimen Banking for People With Tumors of the Central Nervous System

Background: Brain and spinal cord tumors are uncommon. But they contribute substantially to cancer deaths in the U.S. in children and adults. Little progress has been made in treating brain tumors. Researchers want to learn more about these tumors by studying people who have them. Objectives: To understand brain and spinal cord tumors better and uncover areas for further research. Also, to connect people with these tumors to doctors who can help them manage their illness and give them new treatment options. Design: Participants will have an initial (baseline) visit. They will have their medical history taken and undergo physical and neurological exams. They will have blood tests. They may have scans (imaging studies) of the nervous system. If participants have urine or cerebrospinal fluid collected during their regular care, researchers may save some. Brain tumor tissue from a prior surgery may be studied. Genomic DNA testing will be done on samples. Results will be linked to participants medical and/or family history. The number of study visits at NIH will depend on the wishes of participants and their local doctors. Participants will take a brain tumor survey on a computer. They can take it all at once or in 6 separate sections. Participants will answer questions about their general well-being. They will answer questions to learn if they have symptoms of depression or anxiety. Physicians will discuss test results with participants. They will recommend management and treatment options.

Multi-Parametric Quantitative MR Imaging in Evaluation of Brain Tumors

The purpose of the research study is to test new methods that could improve diagnosis and assessment of brain tumors. One of these methods is a new MR (magnetic resonance) imaging technique called magnetic resonance fingerprinting (MRF), which allows for rapidly scanning the patient and provides quantitative information on tumor tissue. The investigators will compare the data gathered from MR Fingerprinting with other imaging tests, clinical information, treatment details and biopsy results to evaluate the accuracy of this new technique.

Local Control, Quality of Life and Toxicities in Adults With Benign or Indolent Brain Tumors Undergoing Proton Radiation Therapy

This research study is studying Proton Radiation as a possible treatment for brain tumor. The radiation involved in this study is: -Proton Radiation

A Trial of Increased Dose Intensity Modulated Proton Therapy (IMPT) for High-Grade Meningiomas

This research study is studying radiation therapy as a possible treatment for meningioma or tumor on the lining of the brain. The study drug or intervention involved in this research study is Intensity Modulated Proton Therapy (IMPT)

Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets

The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier opening with Exablate Model 4000 Type 2.0/2.1 for the treatment of NSCLC brain metastases in patients who are undergoing planned FDA approved, on-label systemic therapy utilizing immune checkpoint inhibitors.

Home Transcranial Direct Current Stimulation (tDCS) to Enhance Functional Recovery

The purpose of this study is to assess the feasibility of home-based Transcranial Direct Current Stimulation (tDCS) combined with a home activity based therapy program in patients with stroke, brain tumors or neurodegenerative conditions and to assess the efficacy of home-based tDCS combined with a home activity-based therapy program as an intervention to treat cognitive-linguistic impairments related to stroke, brain tumors, or neurodegenerative conditions and improve quality of life.

Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

This study investigates the effects of brain radiotherapy on cognitive function by evaluating plasma biomarkers and apolipoprotein E (APOE) genotype in patients with primary or metastatic brain tumors. Standard brain radiotherapy is known to impact cognitive outcomes, yet the underlying biological mechanisms remain unclear.

Study of Letrozole in Recurrent Gliomas

The purpose of this study is to determine the ability of letrozole to penetrate the blood brain barrier and concentrate in gliomas.

Multi-antigen T Cell Infusion Against Neuro-oncologic Disease

This Phase I dose-escalation trial is designed to determine the safety and feasibility of rapidly generated tumor multi-antigen associated specific cytotoxic T lymphocytes (TAA-T) in patients with newly diagnosed diffuse intrinsic pontine gliomas DIPGs (Group A) or recurrent, progressive, or refractory non-brainstem CNS malignancies (Group B). Pediatric and adult patients who have high-risk CNS tumors known to typically have positivity for one or more Tumor Antigen Associated (TAA) (WT1, PRAME and/or Survivin) will be eligible. TAA-T will all be generated from patient peripheral blood mononuclear cells (PBMC). Group A patients (DIPG): The first TAA-T dose will be infused any time 14 days or more after completion of radiotherapy. Group B patients (other recurrent/progressive/refractory CNS tumors): The first TAA-T dose will be infused any time 14 days or more after completing most recent course of conventional (non-investigational) therapy for their disease AND after appropriate washout periods as detailed in eligibility criteria.

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.

Proton Craniospinal Irradiation With Bone Sparing to Decrease Growth Decrement From Radiation

This research study is studying proton radiation as a possible treatment for brain tumor that requires radiation. The radiation involved in this study is: -Proton Radiation

A Phase 2 and Pharmacodynamic Study of Sitagliptin in Patients With Progressive Grade 4 Gliomas

The purpose of this study is to evaluate whether treating glioblastoma patients with sitagliptin can improve immune response against the tumor by targeting specific immune cells called myeloid-derived suppressor cells (MDSCs) that suppress your body's natural immune response against cancer. Sitagliptin is an investigational drug for this condition that works by inhibiting an enzyme called dipeptidyl peptidase 4 (DPP-4), which MDSCs rely on to enter the brain and function. While sitagliptin is FDA-approved for diabetes treatment, its use in glioblastoma is investigational (experimental).

Evaluation of Preoperative Functional Magnetic Resonance Imaging (fMRI) in Patients With Brain Tumors

The purpose of this study is to test the accuracy of using an imaging technique called breath-holding functional magnetic resonance imaging (BH fMRI) in addition to the standard imaging test described above. This study will allow the researchers to find out whether using BH fMRI in combination with the standard approach is the same as, better, or worse than the standard approach used alone.

Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).

This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with diffuse intrinsic pontine glioma (DIPG). DIPG is a rare and aggressive brain tumor with limited treatment options. CAR T cell therapy uses a patient's own immune cells that are changed in a laboratory to recognize and attack cancer cells. The purpose of this study is to determine whether BCB-276, when given after completion of standard radiation therapy, is safe and can improve survival for patients with DIPG. To participate, individuals must be between 1 and 26 years of age when they join the study, have a diagnosis of DIPG, and enroll for treatment within 6 weeks of completing initial radiation therapy. Participants must not have received prior anti-cancer therapy beyond radiation with or without temozolomide prior to joining this study. BCB-276 is administered intraventricularly (into the fluid around the brain), which requires placement of a catheter for treatment. BCB-276 is given every 2 weeks at a research center over a period of several months (approximately 7-8 months). Participation includes travel to a study site, procedures to support treatment administration, sample collection, and ongoing monitoring for safety and effectiveness, with follow-up visits lasting up to about 2 years.

Comprehensive Evaluation of Tumor Oxygenation, Metabolism and Blood Supply of High Grade Glioma and Cervical Cancers Using Dynamic FAZA PET and Multiparametric MR

Primary Objectives To investigate the relationship between dynamic MRI, brain tumor perfusion (DSC) and permeability (DCE), and dynamic 18F-FAZA PET uptake. Secondary Objectives To investigate the relationship between tumors with greater hypoxia defined by qBOLD and 18F-FAZA PET and pathological features including proportionate necrosis, Ki-67 and IDH mutation status To investigate the correlation between the hypoxic tumor region delineated using 18F-FAZA PET and qBOLD

Registry of Patients With Brain Tumors Treated With STaRT (GammaTiles)

The objectives of this registry study are to evaluate real-world clinical outcomes and patient reported outcomes that measure the effectiveness and safety of STaRT.

Neurocognitive Assessment CNSL and LGG

This study is to determine whether self-administered digital cognitive tests can serve as accurate and reliable alternatives to established neuropsychological tests for evaluating cognitive functioning in participants with primary central nervous system lymphoma and low-grade gliomas.

Trial Evaluating an Enhanced Physical Activity Intervention to Improve Cognitive Late Effects in Children Treated With Cranial Radiation for Brain Tumors

Background: \- More children with cancer are surviving into adulthood. Some side effects from treatment go away quickly. But some problems may not go away or may only show up months or years later. These problems are called late effects. Late effects can cause difficulties in cognitive functions, such as attention and memory. Physical activity has been found to improve the attention and memory skills of children with Attention Deficit Hyperactivity Disorder (ADHD). Researchers want to see if physical activity can help with these cognitive problems in children with brain tumors. Objectives: \- To see if physical activity can improve cognitive functions in children who had radiation therapy for a brain tumor. Eligibility: \- Children ages 8 17 who had radiation for a brain tumor at least 2 years ago. They must have access to a computer. Design: * Participants will be screened with height, weight, and medical history. They will answer questions about daily physical activities. Their heart will be checked. * Participants will go to the clinic for 2 days. They will have a fitness exam and tests about attention, memory, and concentration. They will have blood taken and answer questions. Parents will also answer questions. * Participants will be put into 2 groups. For the first 12 weeks, the intervention group will follow a physical activity program. The control group will do their usual physical activities. * For the second 12 weeks, the control group will follow the physical activity program. The intervention group will continue the activities on their own. All groups will track their physical activity with an activity monitor and computer. * Participants will have a follow-up visit at the clinic after each session. They will repeat some of the tests listed above. * The study lasts 24 weeks plus the two follow-up visits. Participants can keep their activity monitor.

Observational Trial of the Impact of Radiation Dose in Children With Brain and Skull Base Tumors.

This is a prospective, observational clinical trial investigating the morphological and volumetric changes in the brain following cranial Radiation Therapy in pediatric patients with brain or skull base tumors.

Mapping of Human Cognition

The purpose of this study is to compare organization of normal brain function as detected using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas) and functional significance to each region involved in cognitive processes as detected by cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a population of patients without overt structural abnormalities in these regions, to generate a spatial probability map of locations of cortical regions "essential" for these processes, to compare the loci of "crucial" language, visual, motor and cognitive sites as determined by CSM with the loci determined by a battery of tasks using fMRI for each individual and to use these data in patients undergoing intracranial electro-corticographyto determine the loci of essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses of these intracranial recordings to study information flow between these areas.

Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

The purpose of this study is to test any good and bad effects of a study drug called abemaciclib (LY2835219) in patients with recurrent brain tumors.

Understanding the Late Effects of Surviving a Pediatric Brain Tumor

The goal of this study is to learn about the cognitive and behavioral functioning of children being treated for cancer.