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Glioma clinical trials

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NCT ID: NCT02666066 Completed - Glioblastoma Clinical Trials

Radiomics for Prediction of Survival in GBM

Radiomics
Start date: January 2016
Phase:
Study type: Observational

Radiomics, the extraction of large amounts of quantitative image features to convert medical images into minable data, is an in-development field that intends to provide accurate risk stratification of oncologic patients. Published prognostic scores only take clinical variables into account. The investigators hypothesize that a combination of CT/MRI features, molecular biology and clinical data can provide an accurate prediction of medical outcome. The long term objective is to build a Decision Support System based on the predictive models established in this study.

NCT ID: NCT02663271 Terminated - Glioblastoma Clinical Trials

TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma

Start date: December 19, 2016
Phase: Phase 2
Study type: Interventional

Glioblastoma multiforme (GBM) is the most common and deadliest primary malignant neoplasm of the central nervous system in adults. Despite an aggressive multimodality treatment approach including surgery, radiation therapy and chemotherapy, overall survival remains poor. Novocure has shown that when properly tuned, very low intensity, intermediate frequency electric fields (TTFields) stunt the growth of tumor cells. The Optune system (NovoTTFTM Therapy) is a portable battery operated device, which produces TTFields within the human body by means of surface transducer arrays. The TTFields are applied to the patient by means of surface transducer arrays that are electrically insulated, so that resistively coupled electric currents are not delivered to the patient. Optune is currently FDA-approved as a single modality treatment for recurrent GBM when both surgical and radiotherapy options have been exhausted as well as combination with adjuvant temozolomide for newly diagnosed GBM. This research study is being performed to determine whether or not TTFields combined with pulsed bevacizumab treatment increases overall survival in patients with bevacizumab-refractory GBM compared to historical controls treated with continuous bevacizumab alone or in combination with other chemotherapy.

NCT ID: NCT02661282 Completed - Glioblastoma Clinical Trials

Autologous CMV-Specific Cytotoxic T Cells and Temozolomide in Treating Patients With Glioblastoma

Start date: June 1, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II trial studies the side effects and best dose of autologous cytomegalovirus (CMV)-specific cytotoxic T cells when given together with temozolomide and to see how well they work in treating patients with glioblastoma. Autologous CMV-specific cytotoxic T cells may stimulate the immune system to attack specific tumor cells and stop them from growing or kill them. Drugs used in chemotherapy, such as temozolomide, may 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. Giving autologous CMV-specific cytotoxic T cells with temozolomide may be a better treatment for patients with glioblastoma.

NCT ID: NCT02659800 Terminated - Malignant Glioma Clinical Trials

Study of the Effect NT-I7 on CD4 Counts in Patients With High Grade Gliomas

Start date: October 30, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the maximum tolerated dose (MTD) and select optimal biological doses (OBD) of the study drug NT-I7 in High Grade Glioma patients with severe lymphopenia, as well as to test the effect of NT-I7 on the CD4 counts of patients in comparison to control participants. This study has both a Phase I and Pilot component.

NCT ID: NCT02658279 Active, not recruiting - Glioma Clinical Trials

Pembrolizumab (MK-3475) in Patients With Recurrent Malignant Glioma With a Hypermutator Phenotype

Start date: January 22, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to test if the study drug called pembrolizumab could control the growth or shrink the cancer but it could also cause side effects. Researchers hope to learn if the study drug will shrink the cancer by half, or prevent it from growing for at least 6 months. Pembrolizumab is an antibody that targets the immune system and activates it to stop cancer growth and/or kill cancer cells.

NCT ID: NCT02655601 Active, not recruiting - Glioblastoma Clinical Trials

Trial of Newly Diagnosed High Grade Glioma Treated With Concurrent Radiation Therapy, Temozolomide and BMX-001

BMX-HGG
Start date: September 25, 2018
Phase: Phase 2
Study type: Interventional

This is a Phase 2 study of newly diagnosed patients with high grade glioma (HGG) undergoing standard radiation therapy and temozolomide treatment. BMX-001 added to radiation therapy and temozolomide has the potential not only to benefit the survival of high grade glioma patients but also to protect against deterioration of cognition and impairment of quality of life. BMX-001 will be given subcutaneously first with a loading dose zero to four days prior to the start of chemoradiation and followed by twice a week doses at one-half of the loading dose for the duration of radiation therapy plus two weeks. Both safety and efficacy of BMX-001 will be evaluated. Impact on cognition will also be assessed. Eighty patients will be randomized to the treatment arm that will receive BMX-001 while undergoing chemoradiation and 80 patients randomized to receive chemoradiation alone. The sponsor hypothesizes that BMX-001 when added to standard radiation therapy and temozolomide will be safe at pharmacologically relevant doses in patients with newly diagnosed high grade glioma. The sponsor also hypothesizes that the addition of BMX-001 will positively impact the overall survival and improve objective measures of cognition in newly diagnosed high grade glioma patients.

NCT ID: NCT02652897 Recruiting - Surgery Clinical Trials

Hemostasis Alterations in Neurosurgical Patients

ABCD
Start date: May 2016
Phase:
Study type: Observational

Prospective, observational study aimed to investigate the specific hemostatic alterations in patients undergoing glial tumor resection.

NCT ID: NCT02644460 Completed - Clinical trials for Diffuse Intrinsic Pontine Glioma

Abemaciclib in Children With DIPG or Recurrent/Refractory Solid Tumors

AflacST1501
Start date: February 2016
Phase: Phase 1
Study type: Interventional

This is a Phase I clinical trial evaluating abemaciclib (LY2835219), an inhibitor of cyclin dependent-kinases 4 and 6 (Cdk 4/6) in children and young adults with newly diagnosed diffuse intrinsic pontine glioma (DIPG) (Stratum A) and in relapsed/refractory/progressive malignant brain (Grade III/IV, including DIPG; MBT) and solid tumor (ST) patients (Stratum B).

NCT ID: NCT02644291 Completed - Glioblastoma Clinical Trials

Phase I Study of Mebendazole Therapy for Recurrent/Progressive Pediatric Brain Tumors

Start date: May 2016
Phase: Phase 1
Study type: Interventional

This is a safety (Phase 1) trial using mebendazole for recurrent pediatric brain cancers that include medulloblastoma and high grade glioma, that are no longing responding to standard therapies. The drug mebendazole is an oral drug in a chewable 500 mg orange flavored tablet. It is already approved to treat parasitic infections. The purpose of this study is to determine the safety and side effects for increasing doses of mebendazole, followed by the treatment of an additional 12 patients at the best tolerated dose.

NCT ID: NCT02632370 Completed - Malignant Gliomas Clinical Trials

5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor

Start date: May 2016
Phase:
Study type: Observational

In support of the US marketing application for 5-ALA, this single arm trial is being conducted to establish the efficacy and safety of Gliolan® (5-ALA) in patients with newly diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan® (5-ALA), as an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with malignant histopathology. The primary objective in this single arm study is to define the positive predictive value (PPV) of Gliolan®-induced PPIX fluorescence for malignant tumor at the time of initial resection and first use of FGS by taking a biopsy of tissue presenting with red fluorescence when observed during the course of resection of new or recurrent malignant gliomas. The functionality and performance reliability of the blue light excitation microscope platforms will be assessed.