Glioma Clinical Trial
Official title:
Phase 2 Trial of Selumetinib in Patients With Neurofibromatosis Type II Related Tumors
In this research study the researchers want to learn more about the effects (both good and bad) the study drug selumetinib has on participants with neurofibromatosis type II (NF2) related tumor. The researchers are asking patients with NF2 related tumors to be in the study, because their hearing has decreased and/or their NF2 related tumor has started to grow. The goals of this study are: - Determine if selumetinib will stop NF2 related tumors from growing - Measure the changes in hearing after receiving selumetinib for 6 months. - Determine if selumetinib improves how participants feel (physically and emotionally) and how participants can perform daily activities. - Examine tumor tissue, if available, in a laboratory to see if NF2 related tumors have targets of selumetinib.
This is a Phase 2 trial to assess the hearing response rate and radiographic response of VS in children and young adults with NF2 who are treated with selumetinib. Dosing will be based on BSA calculated at the beginning of each course. Selumetinib is taken orally twice a day continuously. One course is equivalent to 28 days. Therapy may continue for up to two years (26 courses) in the absence of disease progression or unacceptable toxicity. Dose modifications will be based on Body Surface Area (BSA). In November, 2022 the investigator closed the Stratum 1 arm. Stratum 2 is reserved for patients who exhibit growth of a tumor(s) besides vestibular schwannoma. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04539574 -
An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors
|
N/A | |
| Enrolling by invitation |
NCT04461002 -
Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
|
||
| Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
| Completed |
NCT03242824 -
The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
|
Phase 2 | |
| Recruiting |
NCT04186832 -
Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy
|
N/A | |
| Completed |
NCT00424554 -
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
|
Phase 2 | |
| Recruiting |
NCT05968053 -
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
|
||
| Not yet recruiting |
NCT04550663 -
NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors
|
Phase 1 | |
| Completed |
NCT02805179 -
A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
|
Phase 2 | |
| Terminated |
NCT04556929 -
Enhanced Detection in Glioma Excision
|
N/A | |
| Not yet recruiting |
NCT06408428 -
Glioma Intraoperative MicroElectroCorticoGraphy
|
N/A | |
| Recruiting |
NCT06043232 -
MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
|
||
| Not yet recruiting |
NCT06043765 -
Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
|
N/A | |
| Not yet recruiting |
NCT05025969 -
Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
|
||
| Completed |
NCT02978261 -
Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas
|
Phase 1 | |
| Completed |
NCT01836536 -
Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients
|
N/A | |
| Terminated |
NCT01502605 -
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
|
Phase 1 | |
| Completed |
NCT01479686 -
iMRI Guided Resection in Cerebral Glioma Surgery
|
Phase 3 | |
| Completed |
NCT01212731 -
Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
|
||
| Withdrawn |
NCT00985036 -
Vascular Endothelial Growth Factor (VEGF) Levels in Brain Tumor Patients
|
N/A |