Table 7.
Ongoing Clinical Trials on Gliomas of the Adult and DIPG Including Liquid Biopsy
| Study | Patient population | Type of study | Biofluid | Biomarker | Primary outcome measure | Secondary outcome measure |
|---|---|---|---|---|---|---|
|
NCT03980249 (Phase 1) |
30 newly-diagnosed GBM |
Carvedilol + TTFields + chemoradiation and adjuvant TMZ (6 cycles) | Blood | CTC | - OS - PFS |
- Quantification of CTC
- Correlation of CTC levels and disease burden on MRI measured by RANO criteria |
|
NCT03861598 (Phase 1) |
6 newly-diagnosed GBM |
Carvedilol + chemoradiation and adjuvant TMZ (6 cycles) |
Blood | CTC | - Correlation between CTC and response to treatment on MRI | - Radiological response - Incidence of AEs |
|
NCT04776980 (observational) |
30 GBM |
Ferumoxtyol infusion 20–28 h before brain MRI | Blood | ctDNA | - Correlation between ferumoxytol enhancement on MRI and macrophage quantification on tumor tissue | - Match number of mutations between tumor tissue and in plasma ctDNA |
|
NCT03973918 (Phase 2) |
62 with recurrent BRAF V600E/K-mutated HGG and PXAs |
Encorafenib + binimetinib | Blood | CTC | - Radiological response according to RANO criteria | - PFS - OS - Duration of response - AEs - Detection of CTC |
|
NCT03115138 (observational) |
19 GBM |
Treatment with surgery and chemoradiation | Blood | ctDNA | - Correlation between the molecular abnormalities of GBM ctDNA | NA |
|
NCT02960230 (Phase 1/2) |
49 children with newly-diagnosed DIPG and other Gliomas |
H3.3K27M Peptide Vaccine + Nivolumab | Blood | ctDNA | - OS - AEs |
- H3.3K27M expression status and infiltration of H3.3K27M specific T cells in tumor tissue - Determination of ctDNA as biomarker of tumor burden, response to treatment, or development of drug resistance - detection of H3.3K27M epitope-specific CTL response in post vaccine PBMC in HLA-A2+ children - QoL and cognitive assessment |
|
NCT03990285 (Phase 1) |
30 GBM in patients who progressed following chemoradiation and underwent second surgery |
18F-fluciclovine (Axumin) administration before brain PET/CT scan and contrast-enhanced MRI |
Blood | ctDNA | - To identify pseudoprogression or tumor progression by histopathology | Correlations between histo-pathology and ctDNA |
|
NCT03593993 (observational) |
8 in BRAF-V600E mutated recurrent gliomas |
A biospecimen collection study to evaluate the pharmacokinetic, pharmacodynamic, and resistance profile to trametinib and dabrafenib | Blood, CSF, tumor tissue | ctDNA | - To determine concentrations of dabrafenib and trametinib in tumor tissue - To evaluate feasibility of measuring ctDNA in CSF |
NA |
|
NCT01106794 (observational) |
100 DIPG and brainstem gliomas |
Molecular analysis of samples | Blood, CSF, urine, tumor tissue | RNA and protein expression | - To compare RNA expression in tumor samples, normal brainstem tissue, and CSF. - Validation of results of the genome-wide analysis. - Proteomic profiling of tumor, normal brainstem tissue, and CSF - Protein expression patterns in tumor tissue compared to normal brainstem tissue. |
NA |
|
NCT04185038 (phase 1) |
70 DIPG or diffuse midline glioma and recurrent or refractory pediatric CNS tumors |
B7-H3-Specific CAR T cell loco-regional immunotherapy | Blood, CSF | CTC protein expression | -Tolerability | - To assess the distribution of B7H3-CAR T cells in CSF and peripheral blood - Assessment of disease response using CTC and MRI - Protein expression analysis in CSF as biomarkers of CAR T cell functional activity |
|
NCT03416530 (Phase 1) |
130 Newly-diagnosed DIPG and recurrent pediatric H3K27M gliomas |
ONC201 trial | CSF | ctDNA | H3 K27M DNA levels and drug concentrations in the CSF | - NA |
| NCT04539431 | 220 Glioma brain tumors E12513 SensiScreen glioma |
Sensitive diagnosis, prognosis, and treatment Planning on the open platform. | Blood, CSF | ctDNA | To demonstrate that the E1213 - SensiScreen glioma reveals at least the same number of mutations in comparison with standard tests (digital PCR, methylation-specific PCR) | -NA |
TTFields: Tumor Treating Fields; TMZ: temozolomide; GBM: glioblastoma; qRT-PCR: real-time reverse transcriptase-polymerase chain reaction; OS: overall survival; PFS: progression-free survival; CTC: circulating tumor cells; MRI: magnetic resonance imaging; RANO: Response assessment in neuro-oncology; criteria; AEs: adverse events; ctDNA: circulating tumor DNA; NAv: not available; MG: malignant gliomas; PXAs: anaplastic pleomorphic xanthoastrocytoma; NA: not applicable; DIPG: diffuse midline pontine gliomas; CTL: cytotoxic T lymphocyte; PBMC: peripheral mononuclear cells; QoL: quality of life.