Glioma Clinical Trial
Official title:
Determining the Competence of the Immune System Over the First Year of Therapy in Patients With Glioma: A Battery of Quantitative, Qualitative and Functional Measures of Immune Readiness
This research trial studies qualitative, qualitative, and functional studies over the first year in measuring immune system response in patients with brain tumors. Measuring the number of immune cells, whether these immune cells work correctly, and response to 2 vaccines at several times during the first year of treatment may help find out how active the immune system responds to fight infection and cancer.
PRIMARY OBJECTIVES: I. To describe the quantity of immune cells underlying the antitumor immune response including dendritic cells, naive and activated T- and B-cells, regulatory T-cells, and natural killer cells. II. To determine the proliferative ability of lymphocytes via T-cell activation. SECONDARY OBJECTIVES: I. To describe the immunologic response to the hepatitis A vaccine (or hepatitis B vaccine in those who are hepatitis A exposed) in comparison to expected/known normal responses either prior to (i.e. pre-treatment) or following chemoradiation (i.e. post-treatment). II. To describe the immunologic response to tetanus toxoid vaccination compared to expected/known normal responses either prior to (i.e. pre-treatment) or following chemoradiation (i.e. post-treatment). TERTIARY OBJECTIVES: I. To describe the immunologic response to the yearly influenza vaccination over the course of the first year of therapy for glioma (timing of administration will be when clinically indicated over this year of therapy). II. To describe the frequency of viral infection in glioma patients hospitalized during the respiratory viral season within year 1 of therapy. III. To describe the overall survival of glioma patients enrolled in this study and describe the overall survival in these patients by changes in immunologic function. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients receive standard of care hepatitis A or B vaccine, tetanus toxoid vaccine, and trivalent influenza vaccine and then undergo standard of care treatment external beam radiation therapy and receive standard of care temozolomide. Patients also undergo collection of blood Samples monthly for the first 8 months and then bimonthly for up to 12 months for analysis via flow cytometry, carboxyfluorescein diacetate succinimidyl ester (CFSE) assay, live cell/dead cell distinction assay, and determination of naïve and memory immune response. GROUP II: Patients undergo standard of care treatment and collection of blood samples as in Group I. Patients then receive hepatitis A and tetanus toxoid vaccinations at month 9. ;
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 | |
Terminated |
NCT01502605 -
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
|
Phase 1 | |
Completed |
NCT01836536 -
Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients
|
N/A | |
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
|
||
Not yet recruiting |
NCT00977327 -
Comparison of Neuro-navigational Systems for Resection-Control of Brain Tumors
|
N/A |