Glioblastoma Multiforme of Brain Clinical Trial
Official title:
Randomized Phase 2b Study of Safety And Efficacy Of TVI-Brain-1 Combined With Conformal Radiotherapy And Temozolomide Vs Standard Therapy In Newly Diagnosed MGMT Negative Glioblastoma Multiforme (GBM)
This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The patients' own cancer cells collected after surgery are combined into a vaccine to produce an immune response that significantly increases the number of cancer neoantigen-specific effector T cell precursors in the patient's body. These cancer neoantigen-specific T cells are harvested from the blood, subsequently stimulated and expanded, and infused back into the patient.
This randomized study is designed to compare the combination of TVI-Brain-1 immunotherapy and standard therapy compared to standard therapy alone as a treatment for newly diagnosed MGMT unmethylated glioblastoma patients. The general procedures include the collection and testing of cancer tissue samples after surgery and chemoradiation therapy (radiation and temozolomide). For the patients randomized into the investigational study treatment group, they will also receive two vaccinations created from their own cancer cells, undergo leukapheresis to collect immune T-cells from their blood, and transfer of those activated effector T-cells after chemoradiation therapy. All patients are followed with MRIs at follow-up visits. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03657576 -
Trial of C134 in Patients With Recurrent GBM
|
Phase 1 | |
| Recruiting |
NCT05076513 -
Trial of Niraparib in Participants With Newly-diagnosed Glioblastoma and Recurrent Glioma
|
Early Phase 1 | |
| Active, not recruiting |
NCT03665545 -
Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02474966 -
Effect of Deep TMS on the Permeability of the BBB in Patients With Glioblastoma Multiforme: a Pilot Study
|
Phase 2 | |
| Active, not recruiting |
NCT02137759 -
MRSI to Predict Response to RT/TMZ ± Belinostat in GBM
|
Phase 2 | |
| Enrolling by invitation |
NCT03170141 -
Immunogene-modified T (IgT) Cells Against Glioblastoma Multiforme
|
Phase 1 | |
| Recruiting |
NCT04842513 -
Multi Peptide Vaccination With XS15 in Addition to Standard Postoperative Radiation Therapy and Temozolomide Chemotherapy in Newly Diagnosed Glioblastoma
|
Phase 1 | |
| Recruiting |
NCT04869449 -
Neuro-pharmacological Properties of Repurposed Ketoconazole in Glioblastomas
|
Early Phase 1 | |
| Recruiting |
NCT03633552 -
Efficacy of Two Temozolomide Regimens in Adjuvant Treatment of Patients With Brain High Grade Glioma
|
Phase 3 | |
| Not yet recruiting |
NCT05095441 -
A Clinical Study of Intratumoral MVR-C5252 (C5252) in Patients With Recurrent or Progressive Glioblastoma
|
Phase 1 | |
| Completed |
NCT00003456 -
Antineoplaston Therapy in Treating Patients With Newly-diagnosed Glioblastoma Multiforme
|
Phase 2 | |
| Completed |
NCT03047473 -
Avelumab in Patients With Newly Diagnosed Glioblastoma Multiforme
|
Phase 2 | |
| Enrolling by invitation |
NCT05116137 -
The Impact of Resistance ExerciSe on Muscle Mass in GlioblaSToma Survivors
|
N/A | |
| Recruiting |
NCT05627323 -
CAR T Cells in Patients With MMP2+ Recurrent or Progressive Glioblastoma
|
Phase 1 | |
| Active, not recruiting |
NCT04968366 -
Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery
|
Phase 1 | |
| Suspended |
NCT04222309 -
Laparoscopically Harvested Omental Free Tissue Autograft to Bypass the Blood Brain Barrier (BBB) in Human Recurrent Glioblastoma Multiforme (rGBM)
|
Phase 1 | |
| Not yet recruiting |
NCT06186440 -
Cisplatin Plus Temozolomide Compared With Temozolomide in Patients With MGMT Promotor Unmethylated Glioblastoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06283927 -
The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302)
|
||
| Recruiting |
NCT06273176 -
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
|
||
| Recruiting |
NCT06146725 -
The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)
|