Clinical Trial Results for Brain Cancer

243 Clinical Trials for Brain Cancer

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A Study of Sotorasib in People With Brain Tumors
Description

The researchers are doing this study to find out how effective sotorasib is at getting into KRAS G12C+ brain tumors. The researchers will also find out whether sotorasib is a safe and effective treatment for people undergoing surgical resection of KRAS G12C+ metastatic brain tumors, and do tests that show how the body absorbs, distributes, and gets rid of sotorasib.

Conditions
RECRUITING
Virtual Home-based Exercise Intervention (RISE) to Improve Cancer-Related Cognitive Impairment and Gut Microbiome in Adolescent and Young Adult Brain Tumor Survivors
Description

This clinical trial evaluates the impact of a research intervention of virtually supervised exercise program (RISE) on cancer-related cognitive impairment (CRCI), physical activity in adolescent and young adult (AYA) brain tumor survivors. This clinical trial also evaluates the impact of RISE on the collection of microorganisms that exist in the intestines (gut microbiome). Up to 45% of AYA brain tumor survivors experience CRCI, including issues with attention and memory. CRCI can have a negative impact on education, independent living and can worsen long-term quality of life. Moderate-intensity levels of exercise, particularly aerobic and resistance training, have been shown to improve cognitive function. Additionally, exercise can change the composition and function of the gut microbiome, which may lead to improved cognitive function. Unfortunately, only about 50% of AYAs with cancer receive exercise information or meet the physical activity recommendations. Tailoring a virtually delivered exercise intervention to meet the unique needs of AYAs may improve access to exercise. Participating in the virtual home-based exercise intervention, RISE, may improve physical activity and cognitive impairment in AYA brain tumor survivors and may also help researchers understand the relationship of exercise on the gut microbiome and cognitive function.

RECRUITING
Zr-89 Crefmirlimab Berdoxam and Immuno-Positron Emission Tomography for the Imaging of Patients With Resectable Brain Tumors
Description

This phase I trial studies how well zirconium (Zr)-89 crefmirlimab berdoxam and immuno-positron emission tomography (PET) identifies areas of immune cell activity in patients with brain tumors that can be removed by surgery (resectable). One important predictor of the immune response is the presence and change in CD8 positive (+) tumor infiltrating lymphocytes (TIL) cells. Identifying the presence and changes in CD8+ cells can be challenging, particularly for participants with central nervous system (CNS) tumors, and usually requires invasive procedures such as repeat tissue biopsies, which may not accurately represent the immune status of the entire tumor. Zr-89 crefmirlimab berdoxam is known as a radioimmunoconjugate which consists of a radiolabeled anti-CD8+ minibody whose uptake can be imaged with PET. Upon administration, Zr 89 crefmirlimab berdoxam specifically targets and binds to the CD8+ cells. This enables PET imaging and may detect CD8+ T-cell distribution and activity and may help determine the patient's response to cancer immunotherapeutic agents more accurately. Giving Zr-89 crefmirlimab berdoxam along with undergoing immuno-PET imaging may work better at identifying immune cell activity in patients with resectable brain tumors.

RECRUITING
Atovaquone Combined with Radiation in Children with Malignant Brain Tumors
Description

The goal of this interventional study is to Assess the safety and tolerability of atovaquone in combination with standard radiation therapy (RT) for the treatment of pediatric patients with newly diagnosed pediatric high-grade glioma/diffuse midline glioma/diffuse intrinsic pontine glioma (pHGG/DMG/DIPG). The secondary aim is to assess the safety and tolerability of longer-term atovaquone treatment for pediatric patients with relapsed or progressed pHGG/DMG/DIPG and medulloblastoma (MB) or pHGG/DMG/DIPG after completion of RT and before progression.

RECRUITING
Ommaya Reservoir Placement at the Time of Biopsy for Longitudinal Biomarker Collection in Patients With Brain Tumors
Description

This observational trial evaluates the use of Ommaya reservoir placed during a biopsy to collect biomarkers longitudinally in patients with brain tumor. A biomarker is a measurable indicator of the severity or presence of the disease state. An Ommaya reservoir is a small device that's implanted under the scalp. It allows the doctor to take samples of cerebrospinal fluid (CSF) in the future without doing a spinal tap. The identification of biomarkers in CSF is rapidly emerging as a promising minimally invasive approach for monitoring tumor growth and response to therapy. In the future, these biomarkers may be used to help determine what treatments could be most effective and how well a tumor has responded to prior therapy. Currently, limited long-term access to CSF has made it difficult for studies to learn if collecting CSF at different points in the treatment process is useful. Having an Ommaya reservoir placed during a biopsy may allow for longitudinal biomarker collection in patients with brain tumor.

Conditions
RECRUITING
Identifying Findings on Brain Scans That Could Help Make Better Predictions About Brain Cancer Progression, The GABLE Trial
Description

This phase II trial studies whether different imaging techniques can provide additional and more accurate information than the usual approach for assessing the activity of tumors in patients with newly diagnosed glioblastoma. The usual approach for this currently is magnetic resonance imaging (MRI). This study is trying to learn more about the meaning of changes in MRI scans after treatment, as while the appearance of some of these changes may reflect progressing tumor, some may be due the treatment. Dynamic susceptibility contrast (DSC)-MRIs, along with positron emission tomography (PET) and/or magnetic resonance (MR) spectroscopy, may help doctors tell which changes are a reflection of the treatment and which changes may be due to progressing tumor.

RECRUITING
A Study of 68Ga-PSMA-11 PET Scans in People With Brain Tumors
Description

The purpose of this study is to find out whether 68Ga-PSMA-11 PET/CT is effective in assessing tumor uptake (tumor activity seen in cancerous tissue) in participants with high-grade glioma/HGG or brain metastases.

RECRUITING
Radiologic Pathologic Correlation of Imaging to Distinguish True Progression From Pseudoprogression in Brain Malignancies
Description

To learn if advanced imaging methods can tell apart true progression (the disease has actually gotten worse) from pseudoprogression (the disease appears to have gotten worse, but it actually has not).

RECRUITING
Immunotherapy for Malignant Pediatric Brain Tumors Employing Adoptive Cellular Therapy (IMPACT)
Description

This is an open-label phase 1 safety and feasibility study that will employ multi-tumor antigen specific cytotoxic T lymphocytes (TSA-T) directed against proteogenomically determined personalized tumor-specific antigens (TSA) derived from a patient's primary brain tumor tissues. Young patients with embryonal central nervous system (CNS) malignancies typically are unable to receive irradiation due to significant adverse effects and are treated with intensive chemotherapy followed by autologous stem cell rescue; however, despite intensive therapy, many of these patients relapse. In this study, individualized TSA-T cells will be generated against proteogenomically determined tumor-specific antigens after standard of care treatment in children less than 5 years of age with embryonal brain tumors. Correlative biological studies will measure clinical anti-tumor, immunological and biomarker effects.

RECRUITING
Radiation Induced Alterations in Resting State Brain Networks in Pediatric Brain Tumor Patients
Description

With modern therapy, the survival rate for pediatric brain tumor patients has significantly improved, with over 70% of patients surviving their disease. However, this progress often comes at the cost of substantial morbidity, with cognitive deficits being the primary obstacle to independent living. Robust predictors of cognitive decline and a comprehensive understanding of the underlying mechanisms of cognitive injury remain elusive. This study will prospectively investigate alterations in brain resting state networks following radiation therapy using functional imaging. The hypothesis is that radiation therapy leads to dose-dependent alterations in functional connectivity in the networks associated with higher level cognition, ultimately leading to cognitive decline.

RECRUITING
Guided Meditation During Radiation Therapy for Brain Tumors
Description

The goal of this interventional treatment study is to assess the anxiolytic effect of providing guided meditation during radiation treatment (RT) in patients with brain tumors. The main question it aims to answer is: • What is the change in acute anxiety in participants receiving the mindfulness intervention during radiation therapy compared to standard of care control conditions? Participants will be asked to participate in a 5-minute, audio-recorded mindfulness practice that will be played during the administration of each RT session. Researchers will compare this intervention to standard of care (no intervention) during RT.

Conditions
RECRUITING
Post-Operative Dosing of Dexamethasone in Patients with Brain Tumors After a Craniotomy, PODS Trial
Description

This phase II trial tests the effect of decreasing (tapering) doses of dexamethasone on steroid side effects in patients after surgery to remove (craniotomy) a brain tumor. Steroids are the gold standard post-surgery treatment to reduce swelling (edema) at the surgical site to reduce neurological symptoms. Although, corticosteroids reduce edema, they have side effects including high blood sugar, high blood pressure, and can impair wound healing. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response. It also works to treat other conditions by reducing swelling and redness. Tapering doses dexamethasone may decrease steroid side effects without increasing the risk of edema in patients with brain tumors after a craniotomy.

RECRUITING
Development of MRF for Characterization of Brain Tumors After Radiotherapy
Description

The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, individuals with previously untreated tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study. The primary objectives of this study are: * To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage. * To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis. * To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.

RECRUITING
Magnetic Resonance Imaging for Improving Knowledge of Brain Tumor Biology in Patients With Resectable Glioblastoma
Description

This clinical trial uses a type of imaging scan called magnetic resonance imaging (MRI) to study brain tumor biology in patients with glioblastoma that can be removed by surgery (resectable). Malignant gliomas are the second leading cause of cancer mortality in people under the age of 35 in the United States. Glioblastoma is a type of malignant glioma with very poor patient prognosis. There are currently only about 3 drugs approved by the Food and Drug Administration (FDA) for the treatment of glioblastoma, one of them being administration of bevacizumab, which is very expensive. It is the most widely used treatment for glioblastoma with dramatic results. However, previous clinical trials have not demonstrated an overall survival benefit across all patient populations with glioblastoma that has returned after treatment (recurrent). The study aims to identify which patients who will benefit from bevacizumab therapy by observing MRI images and corresponding imaging biomarkers.

RECRUITING
Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells
Description

The purpose of this project is to validate a new combined MRI and PET imaging technique as a biomarker or measure of glycolysis in brain tumors. To accomplish this, the investigators propose obtaining image-guided measures of tissue pH and biopsied tissue in tumor areas selected for bulk resection surgery. Investigators will then correlate the imaging measurements with pH, RNA expression, protein expression, and bioenergetics measurements of key glycolytic enzymes.

RECRUITING
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
Description

The purpose of this study is to find out how much tratuzumab deruxtecan (T-DXd) can penetrate the tumor when injected into the body, and whether T-DXd may be an effective treatment for brain cancers that express the HER2 protein.

RECRUITING
C-SMART: Cognitive Strategies, Mindfulness, and Rehabilitation Therapy for Patients With Primary Brain Tumors
Description

The goal of Phase IIa Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=36) and their caregivers (N=36) A subset (n=10) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.

RECRUITING
Brain Slice Explants to Predict Drug Response in Brain Tumors
Description

This biospecimen collection study will evaluate the feasibility of engrafting and testing resected Central nervous system (CNS) tumors tumor tissue ex vivo to estimate drug response, in pediatric and adult subjects. CNS tumors display remarkable heterogeneity and unfortunately there are no reliable precision oncology platforms that can identify the most effective therapy for each patient. Recent work has demonstrated the success of functional precision oncology platforms using patient-derived explant (PDE) at predicting drug response in various cancers. Since PDEs maintain important aspects of tumor heterogeneity they may prove effective as functional models for CNS tumors. The purpose of this study is to explore the feasibility of using a novel PDE platform to generate drug sensitivity scores from patients with central nervous system tumors in Pediatric and adult subjects having low- or high-grade CNS tumors resected. The secondary objective is to estimate the proportion of successfully scaled PDEs generated per given tumor size.

RECRUITING
NeuroPathways Intervention for Brain Tumor Patients
Description

This goal of this study is to test an information and support intervention for patients with malignant (or "high-grade") brain tumors. This study was developed to help patients cope after a brain tumor diagnosis. The main question this study aims to answer is whether this intervention (which includes access to an information guide and one-on-one coaching sessions) is feasible (i.e., possible to carry out) and acceptable (i.e., considered helpful) to patients. Participants will be asked to take part in the coaching sessions, use the guide as desired, and complete a small group of short surveys at three different points in time; some participants will be asked to share feedback via exit interviews.

RECRUITING
Cognitive Training in the Virtual Reality Setting With Children Undergoing Radiotherapy for Brain Tumors
Description

The objective of this study is to estimate the feasibility and acceptability of cognitive training in the virtual reality setting with children undergoing radiotherapy for brain tumors. To achieve this goal, the investigators plan to study children undergoing radiotherapy for brain tumors randomly assigned to cognitive training administered via an iPad or virtual reality. Both groups will also participate in cognitive testing and exams using functional near infrared spectroscopy (fNIRS) pre- and post-intervention. The questions to be investigated are: 1. Will cognitive training via virtual reality be feasible and acceptable for children undergoing radiotherapy for brain tumors as indicated by participation rates, adherence and frequency of side effects? 2. Will cognitive training via virtual reality provide neurocognitive benefits? 3. Will there be predictable changes in brain activity as measured by neuroimaging? Findings from this study will be used to develop a larger, definitive trial with direct potential to improve cognitive outcomes for children treated for cancer using a safe and effective alternative to desktop- or laptop-based computerized cognitive interventions with great promise for improving quality of life.

Conditions
RECRUITING
Testing Cerebrospinal Fluid for Cell-free Tumor DNA in Children, Adolescents, and Young Adults with Brain Tumors
Description

Recent advances in technology have allowed for the detection of cell-free DNA (cfDNA). cfDNA is tumor DNA that can be found in the fluid that surrounds the brain and spinal cord (called cerebrospinal fluid or CSF) and in the blood of patients with brain tumors. The detection of cfDNA in blood and CSF is known as a "liquid biopsy" and is non-invasive, meaning it does not require a surgery or biopsy of tumor tissue. Multiple studies in other cancer types have shown that cfDNA can be used for diagnosis, to monitor disease response to treatment, and to understand the genetic changes that occur in brain tumors over time. Study doctors hope that by studying these tests in pediatric brain tumor patients, they will be able to use liquid biopsy in place of tests that have more risks for patients, like surgery. There is no treatment provided on this study. Patients who have CSF samples taken as part of regular care will be asked to provide extra samples for this study. The study doctor will collect a minimum of one extra tube of CSF (about 1 teaspoon or 5 mL) for this study. If the patients doctor thinks it is safe, up to 2 tubes of CSF (about 4 teaspoons or up to 20 mL) may be collected. CSF will be collected through the indwelling catheter device or through a needle inserted into the lower part of the patient's spine (known as a spinal tap or lumbar puncture). A required blood sample (about ½ a teaspoon or 2 3 mL) will be collected once at the start of the study. This sample will be used to help determine changes found in the CSF. Blood will be collected from the patient's central line or arm as a part of regular care. An optional tumor tissue if obtained within 8 weeks of CSF collection will be collected if available. Similarities between changes in the DNA of the tissue that has caused the tumor to form and grow with the cfDNA from CSF will be compared. This will help understand if CSF can be used instead of tumor tissue for diagnosis. Up to 300 people will take part in this study. This study will use genetic tests that may identify changes in the genes in the CSF. The report of the somatic mutations (the mutations that are found in the tumor only) will become part of the medical record. The results of the cfDNA sequencing will be shared with the patient. The study doctor will discuss what the results mean for the patient and patient's diagnosis and treatment. Looking for inheritable mutations in normal cells (blood) is not the purpose of this study. Genetic tests of normal blood can reveal information about the patient and also about the their relatives. The doctor will discuss what the tests results may mean for the patient and the their family. Patient may be monitored on this study for up to 5 years.

RECRUITING
Clinical Trial of the ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Recurrent Brain Tumors
Description

The purpose of this study is to test WSD0628 in combination with radiation therapy for recurrent brain tumors.

Conditions
RECRUITING
Intra-Tumoral Injections of Natural Killer Cells for Recurrent Malignant Pediatric Brain Tumors
Description

This phase I trial tests the safety, side effects, and best dose of ex vivo expanded natural killer cells in treating patients with cancerous (malignant) tumors affecting the upper part of the brain (supratentorial) that have come back (recurrent) or that are growing, spreading, or getting worse (progressive). Natural killer (NK) cells are immune cells that recognize and get rid of abnormal cells in the body, including tumor cells and cells infected by viruses. NK cells have been shown to kill different types of cancer, including brain tumors in laboratory settings. Giving NK cells from unrelated donors who are screened for optimal cell qualities and determined to be safe and healthy may be effective in treating supratentorial malignant brain tumors in children and young adults.

RECRUITING
Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment
Description

This phase II trial tests how well erdafitinib works in controlling IDH-wild type (WT), FGFR-TACC gene fusion positive gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals tumor cells to multiply. This may help keep tumor cells from growing and may kill them. Giving erdafitinib may help to slow the growth of, or to shrink, tumor cells in patients with recurrent or progressive IDH-wild type gliomas with FGFR-TACC gene fusion.

RECRUITING
Feasibility of Transcranial Focused Ultrasound to Measure Brain Tumor
Description

Transcranial focused ultrasound (tFUS) offers a platform for non-invasive imaging and treatment of the brain and pathology of the brain -- allowing high resolution imaging in both spatial and temporal dimensions. Compared with the gold- standard for brain imaging, magnetic resonance imaging (MRI), ultrasound offers reduced contrast while providing improved sampling in time through a significantly more cost-effective approach. In addition, while MRI is used to guide invasive treatments, only ultrasound can offer treatments through three primary mechanisms: 1) neuromodulation, 2) blood brain barrier modulation, and thermal/mechanical ablation through high intensity focused ultrasound (HIFU). All three treatment options require targeting therapy through the skull, which remains a barrier to clinical translation. This proposal is to test the feasibility of acquiring noninvasive targeting imaging intraoperatively prior to clinically indicated cranial neurosurgery. By acquiring volumetric ultrasound images while coregistered to previously obtained stereotactic magnetic resonance imaging, the study will be able to compare the ability of tFUS to identify and focus on brain pathology.

RECRUITING
High-Intensity Interval Exercise in Young Adult Survivors of Pediatric Brain Tumors: A Pilot Feasibility Study
Description

The purpose of this study is to determine whether a 16-week virtual, home-based, high-intensity interval training (HIIT) exercise program will improve physical, cognitive, and emotional health among young adult survivors of pediatric brain tumors. The names of the study interventions involved in this study are/is: * High-Intensity Interval Training (HIIT)

RECRUITING
International Rare Brain Tumor Registry
Description

The objective of the International Rare Brain Tumor Registry (IRBTR) is to better understand rare brain tumors through the collection of biospecimens and matched clinical data of children, adolescents, and young adult patients diagnosed with rare brain tumors.

RECRUITING
Developing a New MRI Technique to Understand Changes in Brain Tumors After Treatment
Description

The purpose of this study is to develop and test a new magnetic resonance imaging (MRI) technique to see if it can be used to tell the difference between tumor growth from worsening of cancer and growth from the effects of treatment in participants who have brain tumors treated with radiation therapy called stereotactic radiosurgery (SRS).

RECRUITING
A Virtually Delivered Exercise Intervention To Mitigate Cognitive Deficits From Radiotherapy In AYAs With Brain Tumors
Description

To test a new investigational virtual exercise program for adolescents and young adults (AYAs) with brain tumors who plan to receive cranial radiotherapy

RECRUITING
Targeting Pediatric Brain Tumors With Sodium Glucose Cotransporter 2 Inhibitors (SGLT2i)
Description

This is a longitudinal, dose-finding, open label safety and tolerability phase Ib treatment study. The study hypothesis is that dapagliflozin will be well-tolerated by brain tumor patients on chemotherapy as assessed by tolerability and side effect profiles.