Glioma

Displaying 81 studies

  • Radiation Therapy With Or Without Temozolomide In Treating Patients With Low-Grade Glioma Jacksonville, FL; Rochester, MN

    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether radiation therapy is more effective when given together with or without temozolomide in treating patients with low-grade glioma.

    PURPOSE: This randomized phase III trial is studying radiation therapy ...

  • A Study Of The Possible Use Of A New Imaging Method With Glioma Tumors Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to see if Magnetic Resonance Elastography (MRE) a recently developed imaging technique can be used to characterize and help stage glioma tumors and evaluate response to therapy.

  • Novel Circular Grid for Electrocorticography During Awake Craniotomy for Glioma Resection Jacksonville, FL

    We will be comparing circular grid to a strip electrode to record electrocorticography.

  • A Study To Evaluate Advanced Development Of Desorption Electrospray Ionization Mass Spectrometry For Intraoperative Molecular Diagnosis Of Brain Cancer Jacksonville, FL

    The purpose of this study is to explore the translational abilities of desorption electrospray ionization mass spectrometry (DESI-MS) as intraoperative diagnostic tool to identify cancerous versus noncancerous tissue and estimate the percentage of tumor infiltration in tissue biopsies, by monitoring depletion of N-acetylaspartate (NAA) and aberrations of the phospholipid signature of neurological tissue; and to identify the presence of IDH mutations by monitoring the 2-hydroxyglutarate (2HG) and, therefore, differentiate between IDH-mutant and wild-type gliomas.

  • A Study Of The Drugs Selumetinib Vs. Carboplatin And Vincristine In Patients With Low-Grade Glioma Rochester, MN

    This study aims to demonstrate that the efficacy of treatment with selumetinib as measured by event-free survival (EFS) is non-inferior compared to treatment with carboplatin/vincristine (CV) in previously-untreated low-grade glioma (LGG) not associated with BRAFV600E mutations or systemic neurofibromatosis type 1 (NF1).

  • Genomic Analysis of Glioma Tissue Samples Rochester, MN

    The purpose of this study is to use stored glioma specimens stored by the Tissue Registry under the oversight of the Neuro-Oncology program.

  • Study To Determine The Impact Of Advanced Magnetic Resonance Imaging (MRI) Using 18F-DOPA (A Chemical Tracer That Highlights Certain Cells During Imaging) During Planning For Proton Beam Radiation Therapy. Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to utilize a novel approach of combining advanced radiation delivery with proton beam therapy with advanced tumor visualization with 18F-DOPA PET and MRI imaging. We will study the effectiveness and safety of this technique delivering the entire treatment over 1-2 weeks.

  • Telehealth Assessments With Glioma Receiving Oral Chemotherapy Rochester, MN

    The purpose of this study is to evaluate the safety, feasibility and acceptability of telehealth assessments for patients with GBM receiving oral chemotherapy.

  • A Study Of Genetic Testing In The Care Of Glioma Patients Rochester, MN

    The purpose of this study is to validate the effectiveness and clinical use of array and next generation sequencing tests in hopes of adopting these tests as standard of care and advancing glioma patient care and clinical practice at Mayo Clinic and beyond.

  • Shear Wave Elastography For Intraoperative Brain And Glioma Stiffness Measurements Jacksonville, FL

    The purpose of this study is to determine the feasibility of utilizing ISWEU measurements intraoperatively and in the human brain to measure tissue stiffness.

  • A Study Of ONC201 For Patients With H3 K27M-mutant And/or Midline High Grade Gliomas Jacksonville, FL; Rochester, MN

    The purpose of this project is to provide expanded access to ONC201 for patients with previously-treated H3 K27M-mutant and/or midline high grade gliomas who cannot access ONC201 through clinical trials.

  • A Study To Assess Metabolic Changes In The Blood With Standard Treatment In Patients With Gliomas Rochester, MN

    The purpose of this study is to generate preliminary data on the impact of standard, first line treatment on the plasma metabolome of patients with a new diagnosis of glioma.

  • A Pilot Study Using 18F-DOPA PET-guided Radiotherapy In Gliomas Rochester, MN

    For most brain tumors, radiation treatment is guided by a Magnetic Resonance Imaging (MRI) scan. In this study, information from a special scan, called a Positron Emission Tomography/ Computed Tomography (PET/CT) scan using an amino acid called Fluorine-18-L-dihydroxyphenylalanine (18F-DOPA) will also be used to image the tumor and guide your radiation oncologist in determining locations to treat with radiation. This type of scan has shown promise in being able to better distinguish tumor from normal brain tissue and may help to more accurately plan radiation treatment. This type of scan can also assist the radiation oncologist in identifying the most ...

  • Proton Beam Or Intensity-Modulated Radiation Therapy In Preserving Brain Function In Patients With IDH Mutant Grade II Or III Glioma Rochester, MN

    This randomized phase II clinical trial studies the side effects and how well proton beam or intensity-modulated radiation therapy works in preserving brain function in patients with IDH mutant grade II or III glioma. Proton beam radiation therapy uses tiny charged particles to deliver radiation directly to the tumor and may cause less damage to normal tissue. Intensity-modulated or photon beam radiation therapy uses high-energy x-ray beams shaped to treat the tumor and may also cause less damage to normal tissue. Patients will be more likely to be randomized to proton beam radiation therapy. It is not yet known if ...

  • Radiation Therapy With Or Without Temozolomide In Treating Patients With Anaplastic Glioma Jacksonville, FL; Rochester, MN

    RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with temozolomide may kill more tumor cells. It is not yet known whether giving temozolomide during and/or after radiation therapy is more effective than radiation therapy alone in treating anaplastic glioma.

    PURPOSE: This randomized phase III trial is studying giving temozolomide during and/or after radiation therapy to see how well it works compared to radiation therapy ...

  • STAT3 Expression in Patients with Diffused Intrinsic Pontine Glioma (DIPG) Rochester, MN

    The purpose of this study is to verify the gene array data by examining the protein expression in brain tissue of diffuse intrinsic pontine glioma (DIPG) patients compared to normal healthy subjects using western blot.

  • SPORT-DMG Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to evaluate the clinical outcomes of hypofractionation with planned courses of re-irradiation for patients with diffuse midline gliomas of the pons.

    Subjects will be screened by neurosurgery, radiation oncology, or pediatric oncology at outpatient clinic or by the multidisciplinary pediatric central nervous system tumor conference. Interested qualified patients and their families will be consented and offered participation in this study

  • Ommaya At Biopsy Rochester, MN

    The purpose of this study is to determine the feasibility of placing Ommaya reservoirs at the time of biopsy to enable longitudinal CSF monitoring.

  • Natural History of Brain Function, Quality of Life, and Seizure Control in Patients with Brain Tumor Who Have Undergone Surgery Scottsdale/Phoenix, AZ; Rochester, MN

    This trial studies the natural history of brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery. Learning about brain function, quality of life, and seizure control in patients with brain tumor who have undergone surgery may help doctors learn more about the disease and find better methods of treatment and on-going care.

  • A Study of Fluorine F 18 Fluorodopa-Labeled PET Scans for Planning Surgery and Radiation Therapy to Treat Patients who have Newly Diagnosed High- or Low-Grade Glioma Brain Cancer Tumors Rochester, MN

    The purpose of this study is to evaluate the use of fluorine F 18 fluorodopa-labeled PET scanning for the planning of surgery and radiation therapy to treat patients who have newly diagnosed high- or low-grade glioma brain tumors. New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scans, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.

     

  • A Study To Evaluate The Optune® (Tumor Treating Fields) Concomitant With RT & TMZ To Treat Newly-diagnosed Glioblastoma Scottsdale/Phoenix, AZ; Jacksonville, FL

    The purpose of this study is to test the effectiveness and safety of Optune® given concomitantly with radiation therapy (RT) and temozolomide (TMZ) in newly diagnosed GBM patients, compared to radiation therapy and temozolomide alone. In both arms, Optune® and maintenance temozolomide are continued following radiation therapy.

  • The NeoGlioma Study Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This study aims to evaluate the safety of preoperative radiosurgery in the treatment of patients with biopsy-proven high grade glioma prior to conventional therapy. Safety is defined as any acute grade 3 (CTCAE v5.0) or greater unplanned adverse event from the time of enrollment until 4 weeks following postoperative radiotherapy.

  • ONC201 In H3 K27M-mutant Diffuse Glioma Following Radiotherapy (The ACTION Study) Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the effectiveness of ONC201 administered following radiotherapy in participants with H3 K27M-mutant diffuse glioma.

  • Extracellular Impact Of Ultrasound-induced Blood-brain Barrier Disruption Rochester, MN

    The purpose of this study is to determine the impact of focused ultrasound (FUS) on the composition of the tumor extracellular microenvironment.

  • A Digital Treatment Platform For The Delivery Of Home-Based Sequential Therapy In Patients With Glioma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This clinical trial tests how well a digital treatment platform using a mobile application works for the delivery of home-based sequential therapy in patients with glioma. Access to specialized neuro-oncology care in the United States for patients with glioma is critically deficient. Care at centers with neuro-oncology specialists is associated with improved survival outcomes, yet many patients have limited access due to distance, disease-related disability, or lack of financial resources. The application provides patients continuous access to their care team in the home setting. A digital treatment platform may increase clinical trial participation and accelerate development of novel therapeutics while ...

  • A Trial Of Enzastaurin Plus Temozolomide During And Following Radiation Therapy In Patients With Newly Diagnosed Glioblastoma With Or Without The Novel Genomic Biomarker, DGM1 Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to assess whether there is superiority of overall survival (OS) when enzastaurin rather than placebo is added to the regimen of temozolomide with radiation therapy followed by temozolomide for the treatment of patients with newly diagnosed glioblastoma in Denovo Genomic Marker 1 (DGM1) biomarker-positive patients.

  • A Study Of CGM In GBM Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to compare standard glucose monitoring versus continuous glucose monitoring (CGM) with endocrinology-guided intervention in newly diagnosed glioblastoma (GBM) patients receiving standard-of-care therapy.

  • Obtain Fresh Glioblastoma Tissue To Analyze Cell Count And Viability In Developing IGV-001 Jacksonville, FL

    The purpose of this study is to utilize fresh tumor tissue to aid the development of future therapies for brain cancer.  

  • SIGMA (Safusidenib In IDH1 Mutant Glioma Maintenance) Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent/progressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.

    The purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.

    The purpose of Part 3 will be to evaluate the efficacy of safusidenib ...

  • Blood-Brain Barrier Disruption (BBBD) For Liquid Biopsy In Subjects With GlioBlastoma Brain Tumors Rochester, MN

    The purpose of this study is to evaluate the safety and effectiveness of using Exablate Model 4000 Type-2.0/2.1 in adults with Glioblastoma brain tumors to increase temporarily the permeability of the blood brain barrier, allowing increased passage of circulating free DNA (cfDNA) for sampling and analysis.

  • Dose-Escalated Photon IMRT Or Proton Beam Radiation Therapy Versus Standard-Dose Radiation Therapy And Temozolomide In Treating Patients With Newly Diagnosed Glioblastoma Scottsdale/Phoenix, AZ; Rochester, MN

    This randomized phase II trial studies how well dose-escalated photon intensity-modulated radiation therapy (IMRT) or proton beam radiation therapy works compared with standard-dose radiation therapy when given with temozolomide in patients with newly diagnosed glioblastoma. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells and shrink tumors. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs, such as temozolomide, may make tumor cells more sensitive to radiation therapy. It is not yet known whether dose-escalated photon IMRT ...

  • A Study Of Using Geometrically Accurate Functional MRI To Enable Personalized Radiotherapy Of Glioblastoma Scottsdale/Phoenix, AZ

    The purpose of this study is to create a new Magnetic resonance imaging (MRI) technique with true contrast to the background reference points in functional MR images of individual patients. Functional MRI has been widely used in staging, grading and treatment response monitoring of glioblastoma.  MRI has great soft tissue and tumor tissue contrast and can assist in outlining the target. It has proven able to offer functional information such as cell density, permeability of the micro-blood vessels, and the oxygen level of the tumor.

  • Study Of GI-102 And PD-1 In Glioblastoma Rochester, MN

    The purpose of this study to assess pharmacodynamic (PD) changes in tumor tissue.

  • Short Course Radiotherapy For The Treatment Of Patients With Glioblastoma, SAGA Study Albert Lea, MN; Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Mankato, MN; Rochester, MN

    The purpose of this study is to demonstrate non-inferior 12-month overall survival of patients with GlioblastomA (GBM) treated with dose escalated hypofractionated radiotherapy compared to standard of care. Also, to demonstrate the safety and favorable quality of life via physician-reported G3+ toxicitycompare if SBRT is non-inferior to standard of care on the proportion of overall survival of patients with glioblastoma 12 months after randomization.

     

  • Intratumoral Extracellular Metabolic Impact Of DFMO And AMXT 1501 In Patients With Diffuse Or High Grade Glioma Rochester, MN

    The purpose of this study is to determine how polyamine depletion impacts extracellular intratumoral guanidinoacetate abundance.

    In addition: to determine the impact of polyamine depletion on polyamine abundance and the global extracellular metabolome within live human gliomas, in situ; to assess the feasibility of longitudinal microdialysis for combined pharmacokinetic and pharmacodynamic analysis within live human gliomas in situ in the postoperative setting; to assess the CNS pharmacokinetics of DFMO and AMXT 1501; to assess the short-term safety of study drugs in patients with high-grade gliomas.

  • INdividualized Screening Trial Of Innovative Glioblastoma Therapy (INSIGhT) Rochester, MN

    This research study is studying several investigational drugs as a possible treatment for Glioblastoma (GBM). The drugs involved in this study are : - Abemaciclib - Temozolomide (temodar) - Neratinib - CC115

  • A Study To Evaluate CB-839 With Radiation Therapy And Temozolomide In Treating Participants With IDH-Mutated Diffuse Astrocytoma Or Anaplastic Astrocytoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to evaluate the side effects and best dose of  CB-839 hydrochloride (CB-839) in combination with radiation therapy and temozolomide in treating participants with IDH-mutated diffuse or anaplastic astrocytoma. CB-839 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or stopping them from spreading. Giving CB-839 with ...

  • A Study To Determine How BI 907828 Is Taken Up In The Tumor And To Determine The Highest Dose Of BI 907828 That Could Be Tolerated In Combination With Radiation Therapy In People With A Brain Tumor Called Glioblastoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to examine the pharmacological effects of the compound BI 907828 on patient tumors at an early stage of drug development.

  • A Phase 2b Clinical Study With A Combination Immunotherapy In Newly Diagnosed Patients With Glioblastoma - The ImmuneSense Study Jacksonville, FL

    The purpose of this study is to assess progression-free survival (PFS) and overall survival (OS) in newly diagnosed Glioblastoma multiforme (GBM) participants treated with IGV-001 as compared with placebo.

  • Image-based Mapping Of Brain Tumors Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to combine MRI images with histologic and genetic analysis of cancer (from blood and tissue samples) to improve the overall accuracy of diagnosis and effectiveness of cancer treatment.

     

  • Study Of Vorasidenib (AG-881) In Participants With Residual Or Recurrent Grade 2 Glioma With An IDH1 Or IDH2 Mutation (INDIGO) Jacksonville, FL; Rochester, MN

    The purpose of this study is to compare the effectiveness of AG-881 to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization.

  • DSC-MRI In Measuring Relative Cerebral Blood Volume For Early Response To Bevacizumab In Patients With Recurrent Glioblastoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This phase II trial studies how well dynamic susceptibility contrast-enhanced magnetic resonance imaging (DSC-MRI) works in measuring relative cerebral blood volume (rCBV) for early response to bevacizumab in patients with glioblastoma that has come back. DSC-MRI may help evaluate changes in the blood vessels within the cancer to determine a patient?s response to treatment.

  • Treatment Of Patients With Recurrent High-Grade Glioma With APG-157 And Bevacizumab Rochester, MN

    The purpose of this study is to assess the toxicity and effectiveness of bevacizumab with APG-157 for recurrent high grade glioma patients with disease progression after bevacizumab.

  • Pazopanib Hydrochloride in Treating Patients with Advanced or Progressive Malignant Pheochromocytoma or Paraganglioma Jacksonville, FL; Rochester, MN

    This phase II trial studies how well pazopanib hydrochloride works in treating patients with advanced or progressive malignant pheochromocytoma or paraganglioma. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

  • Adipose-Derived Mesenchymal Stem Cells (AMSCs) For Recurrent Glioblastoma Jacksonville, FL

    This study aims to evaluate the safety of local delivery of AMSCs for recurrent GBM by noting the incidence of adverse events, as well as radiological and clinical progression.

    To assess the preliminary efficacy of local delivery of AMSCs for recurrent GBM by comparing the clinical, survival, progression, and radiographic outcomes from patients enrolled in our study to historical controls from our institution.

  • Study Of Vorasidenib And Pembrolizumab Combination In Recurrent Or Progressive IDH-1 Mutant Glioma Jacksonville, FL

    Vorasidenib in combination with pembrolizumab in participants with recurrent or progressive isocitrate dehydrogenase-1 (IDH-1) mutant Glioma.

  • A Study Of Berubicin In Adult Subjects With Recurrent Glioblastoma Multiforme Jacksonville, FL; Rochester, MN

    The primary objective of this study is to assess the effect of berubicin compared with lomustine on overall survival (OS) in adult patients with Glioblastoma Multiforme (GBM) (WHO Grade IV) that has recurred after standard initial therapy.

  • A Study Of Sonodynamic Therapy With SONALA-001 And Exablate 4000 Type 2.0 In Subjects With Progressive Or Recurrent Glioblastoma Multiforme (RGBM) Rochester, MN

    The purpose of this study is to characterize the safety, dose limiting toxicities (DLTs), maximum tolerated dose (MTD), maximum administered dose (MAD) and recommended phase 2 dose (RP2D) for future study after treatment with SONALA-001 in combination with MRgFUS in subjects with progressive or rGBM.

  • Efineptakin Alfa (NT-I7) Plus Pembrolizumab For The Treatment Of Recurrent Glioblastoma Rochester, MN

    The purpose of this study is to determine the response rate to the combination of pembrolizumab and NT-I7 in patients with recurrent glioblastoma.

  • Retifanlimab With Bevacizumab And Hypofractionated Radiotherapy For The Treatment Of Recurrent Glioblastoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class ...

  • A Study To Evaluate Pembrolizumab With Standard Therapy To Treat Newly-diagnosed Glioblastoma Scottsdale/Phoenix, AZ; Rochester, MN

    This phase II trial studies the side effects and how well pembrolizumab works in combination with standard therapy in treating patients with glioblastoma. Drugs used in the chemotherapy, such as pembrolizumab and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving pembrolizumab and standard therapy comprising of temozolomide and radiation therapy may kill tumor cells.

  • Retifanlimab With Bevacizumab And Hypofractionated Radiotherapy For The Treatment Of Recurrent Glioblastoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class ...

  • A Feasibility Study To Evaluate The Safety Of The TheraSphere Glioblastoma (GBM) Device In Patients With Recurrent GBM Jacksonville, FL

    The purpose of this study is to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent glioblastoma (GBM).

  • A Trial To Evaluate Multiple Regimens In Newly Diagnosed And Recurrent Glioblastoma Jacksonville, FL; Rochester, MN

    The primary purposes of this study are to identify experimental therapies that improve OS for GBM patients in the Screening stage (Stage 1), determining if predefined patient subtypes or associated biomarkers uniquely benefit from the treatment and to confirm identified effective experimental therapies and associated biomarker signatures in an expansion stage (Stage 2) designed to support a new drug application.

     

     

     

  • Safety And Efficacy Study Of TX103 CAR-T Cell Therapy For Recurrent Or Progressive Grade 4 Glioma. Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    This is a phase I, open-Label, single/multiple dose, dose-escalation study to evaluate the safety, tolerability and antitumor activity of anti-B7-H3 CAR-T cell injection (TX103) in subjects with recurrent or progressive Grade 4 Glioma.The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.

  • A Study Comparing Abemaciclib Plus Temozolomide To Temozolomide Monotherapy In Children And Young Adults With High-grade Glioma Following Radiotherapy Rochester, MN

    The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.

  • An Investigational Scan (Ga-68 PSMA-11 PET/CT) For Detection Of Disease Recurrence Or Progression In Patients With Glioma Rochester, MN

    This clinical trial evaluates whether gallium-68 (Ga-68) prostate specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT) imaging is useful in differentiating between disease that has come back after a period of improvement (recurrence) or that is growing, spreading, or getting worse (progression) and treatment effect in patients with glioma. Patients with glioma undergo frequent imaging for assessment of disease status. After first-line treatment however, the correlation between imaging findings and tumor activity can be confused, and surgery is often required for definitive diagnosis. The PET/CT scanner is an imaging machine that combines 2 types of imaging in a ...

  • A Study To Compare Treatment With The Drug Selumetinib Alone Versus Selumetinib And Vinblastine In Patients With Recurrent Or Progressive Low-Grade Glioma Rochester, MN

    The primary objectives of this study are to determine the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) of selumetinib + vinblastine for children with progressive or recurrent LGGs, and to determine if selumetinib + vinblastine will lead to improved event-free survival (EFS) outcome compared with selumetinib alone for children with progressive or recurrent LGGs.

  • Vorinostat, Temozolomide, or Bevacizumab in Combination with Radiation Therapy Followed by Bevacizumab and Temozolomide in Young Patients with Newly Diagnosed High-Grade Glioma Rochester, MN

    This randomized phase II/III trial is studying vorinostat, temozolomide, or bevacizumab to see how well they work compared with each other when given together with radiation therapy followed by bevacizumab and temozolomide in treating young patients with newly diagnosed high-grade glioma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. ...

  • Study To Evaluate Eflornithine + Lomustine Vs Lomustine In Recurrent Anaplastic Astrocytoma (AA) Patients Jacksonville, FL; Rochester, MN

    The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.

  • A Study Of Vaccine Therapy In Treating Patients With Recurrent Glioblastoma Rochester, MN

    The purpose of this study is to evaluate the side effects of vaccine therapy in treating patients with glioblastoma that has come back. Vaccines made from a person's white blood cells mixed with tumor proteins from another person's glioblastoma tumors may help the body build an effective immune response to kill tumor cells. Giving vaccine therapy may work better in treating patients with glioblastoma.

  • A Study Testing The Effect Of Immunotherapy (Ipilimumab And Nivolumab) In Patients With Recurrent Glioblastoma With Elevated Mutational Burden Scottsdale/Phoenix, AZ; Eau Claire, WI; Jacksonville, FL; La Crosse, WI; Rochester, MN

    The purpose of this study is to evaluate the effect of immunotherapy drugs (ipilimumab and nivolumab) in treating patients with glioblastoma that has come back (recurrent) and carries a high number of mutations. Cancer is caused by changes (mutations) to genes that control the way cells function. Tumors with high number of mutations may respond well to immunotherapy. Immunotherapy with monoclonal antibodies such as ipilimumab and nivolumab may help the body's immune system attack the cancer and may interfere with the ability of tumor cells to grow and spread. Giving ipilimumab and nivolumab may lower the chance of recurrent glioblastoma ...

  • A Study for Cerebral Open Flow Microperfusion Rochester, MN

    The purpose of this study is to evaluate the safety and feasibility of intra-operative microperfusion during a planned neurosurgical resection of diseased brain parenchyma, including either an epileptic focus requiring temporal lobectomy or a glioma. Devices used for microperfusion are Joanneum Research’s cerebral open flow microperfusion (OFM) catheters, push and pull tubing, and MPP102-II pump.

  • A Study To Analyze NMS-03305293 And Temozolomide In Adult Patients With Recurrent Glioblastoma Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The objectives of this study are to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) of NMS-03305293 in combination with temozolomide (TMZ) in patients with diffuse gliomas at first relapse (Phase I),  and to determine the antitumor effectiveness of the combination of NMS-03305293 and TMZ in patients with isocitrate dehydrogenase (IDH) wild type glioblastoma at first relapse as measured by the 6-month Progression Free Survival (PFS) rate (Phase II).

  • A Study To Test The Efficacy, Safety, And Pharmacokinetics Of Rozanolixizumab In Adult Study Participants With Leucine-Rich Glioma Inactivated 1 Autoimmune Encephalitis Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of the study is to assess the efficacy of rozanolixizumab as measured by seizure freedom, change in cognitive function, use of rescue medication, onset of seizure freedom and to assess safety and tolerability.

  • Dabrafenib Combined With Trametinib After Radiation Therapy In Treating Patients With Newly-Diagnosed High-Grade Glioma Rochester, MN

    The purpose of this study is to estimate the event-free survival (EFS) distribution for newly-diagnosed patients with BRAFV600-mutant high-grade glioma (HGG) without H3 K27M mutations excluding anaplastic pleomorphic xanthoastrocytoma (aPXA) and anaplastic ganglioglioma (aGG) treated with radiation therapy followed by a maintenance combination of dabrafenib and trametinib and to compare this EFS to contemporary historical controls.

  • Dasatinib and Bevacizumab in Treating Patients With Recurrent or Progressive High-Grade Glioma or Glioblastoma Multiforme Rochester, MN

    RATIONALE: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also block the growth of the tumor by blocking blood flow to the tumor. It is not yet known whether bevacizumab together with dasatinib are more effective than a placebo in treating patients with recurrent or progressive high-grade glioma or glioblastoma multiforme. ...

  • Genetic Epidemiology of Glioma-International Consortium Rochester, MN

    The purpose of this study is to identify common genetic variants contributing to the risk of glioma.  Evaluate gene-gene and gene-environmental interactions with strong biologic relevance to identify gene-gene and gene-environment interactions for glioma risk. 

  • A Study To Explore If It Is Possible To Successfully Obtain Optical Coherence Tomography (OCT) Imaging And Data While Patients Undergo Brain Surgery Jacksonville, FL

    The goal of this study is to investigate the feasibility of successfully obtaining intra-operative OCT imaging and data during standard brain surgery.

  • Retifanlimab And Epacadostat In Combination With Radiation And Bevacizumab In Patients With Recurrent Gliomas Scottsdale/Phoenix, AZ; Rochester, MN

    The purpose of this study is to assess the combination of INCMGA00012 with radiation therapy (RT) and bevacizumab with or without epacadostat in the treatment of recurrent glioblastoma (GBM). Regimen A of this study has been completed and Mayo Clinic will only be participating in the Regimen B portion.

  • A Study Of The Drugs Selumetinib Versus Carboplatin/Vincristine In Patients With Neurofibromatosis And Low-Grade Glioma Rochester, MN

    The pupose of this study is to evaluate whether or not selumetinib works just as well as the standard treatment with carboplatine/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by ...

  • Developing Criteria For Treatment Of Neurofibromatosis Type 1 Associated Optic Pathway Glioma Rochester, MN

    The purpose of this research study is to understand the natural history of vision in patients with OPG and determine if there are factors (e.g. age at diagnosis, male/female, tumor location, features of the MRI exam, etc) that predict future vision loss or change in tumor size.

    Another purpose of the study is to collect and store blood and tissue samples to use for future research to evaluate if there are certain variations in DNA, RNA, or proteins that predict the likelihood of an OPG to grow or cause vision loss.

  • Wild-Type Reovirus In Combination With Sargramostim In Treating Younger Patients With High-Grade Relapsed Or Refractory Brain Tumors Rochester, MN

    This phase I trial studies the side effects and the best dose of wild-type reovirus (viral therapy) when given with sargramostim in treating younger patients with high grade brain tumors that have come back or that have not responded to standard therapy. A virus, called wild-type reovirus, which has been changed in a certain way, may be able to kill tumor cells without damaging normal cells. Sargramostim may increase the production of blood cells and may promote the tumor cell killing effects of wild-type reovirus. Giving wild-type reovirus together with sargramostim may kill more tumor cells.

  • A Study To Evaluate The Feasibility Of Intraoperative Microdialysis (Tissue Sampling) During Neurosurgery For Central Nervous System Malignancies Rochester, MN

    Intraoperative Microdialysis During Neurosurgery for Central Nervous System Malignancies

  • Patient Adherence and Symptoms During Post-operative Fluid Restriction Protocol After Transsphenoidal Surgery Jacksonville, FL

    The objectives of this study are to survey patients during the post-operative period regarding their experience with fluid restriction including adherence and discomfort, and to document rates of hyponatremia and readmissions in post-operative patients.

    Advances in endonasal, endoscopic transsphenoidal surgical techniques have decreased complications and length of stay for persons undergoing resection of sellar and suprasellar masses  Previous research by investigators now at Mayo (SLS, AQH) has shown that particular interventions including fluid restriction post-operatively decrease patient morbidity (e.g., from hyponatremia) and readmissions while maintaining patient safety. However, the patient perspective on the impact of fluid restriction has not ...

  • Phase 1/2 Study Of BDTX-1535 In Patients With Glioblastoma Or Non-Small Cell Lung Cancer With EGFR Mutations Jacksonville, FL; Rochester, MN

    BDTX-1535-101 is an open-label, Phase 1 dose escalation and Phase 2 multiple cohort study designed to evaluate the safety, pharmacokinetics (PK), optimal dosage, central nervous system (CNS) activity, and antitumor activity of BDTX-1535. The study population comprises adults with either advanced/metastatic non-small cell lung cancer (NSCLC) with non-classical or acquired epidermal growth factor receptor (EGFR) resistance (EGFR C797S) mutations with or without CNS disease (in Phase 1 and Phase 2), or glioblastoma multiforme (GBM) expressing EGFR alterations (Phase 1 only). All patients will self administer BDTX-1535 monotherapy by mouth in 21-day cycles. Phase 1 enrollment is now complete. Phase 2 ...

  • A Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Anti-tumor Activity Of WSD0922-FU Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    The purpose of this study is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of WSD0922-FU in subjects with recurrent glioblastoma, IDH wildtype (GBM), anaplastic astrocytoma, IDH wildtype (AA) and CNS metastases of non-small cell lung cancer (NSCLC).

  • Innovative Trial For Understanding The Impact Of Targeted Therapies In NF2 Rochester, MN

    The purpose of this study is to test multiple experimental therapies simultaneously in patients with neurofibromatosis type 2 (NF2) with associated progressive tumors of vestibular schwannomas (VS), non-vestibular schwannomas (non-VS), meningiomas, and ependymomas. This Master Study is being conducted as a "basket" study that may allow people with multiple tumor types associated with NF2 to receive new drugs throughout this study. Embedded within the Master Study are individual drug substudies. - Investigational Drug Sub-study A: Brigatinib.

  • Gemini Study To Evaluate The Integration Of Cancer Genetic Testing Into A Cancer Clinical Practice At Mayo Clinic At Arizona Scottsdale/Phoenix, AZ; Jacksonville, FL

    The purpose of this study is to determine the prevalence of genetic mutations in cancer patients from various ethnic populations seeking care at Mayo Clinic cancer clinics.

  • Mayo Clinic Cancer Center Neuro-Oncology Program Registry And Biobank For The Study Of Nervous System Tumors Rochester, MN

    Biospecimen banks are a modern attempt to centralize collections of human blood and tissue samples along with health information and personal history. The Neuro-Oncology Program Registry and Biobank will be used for research purposes to increase our understanding of nervous system tumors.

  • The Circulating Cell-free Genome Atlas Study Scottsdale/Phoenix, AZ; Jacksonville, FL; Rochester, MN

    GRAIL is using deep sequencing of circulating cell-free nucleic acids (cfNAs) to develop assays to detect cancer early in blood. The purpose of this study is to collect biological samples from donors with a new diagnosis of cancer (blood and tumor tissue) and from donors who do not have a diagnosis of cancer (blood) in order to characterize the population heterogeneity in cancer and non-cancer subjects and to develop models for distinguishing cancer from non-cancer.

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