Glioblastoma Multiforme Clinical Trial
Official title:
A Pilot Study to Assess the Safety, Feasibility, and Preliminary Efficacy of a Neoepitope-based Personalized Vaccine Approach in Patients With Newly Diagnosed Glioblastoma
The early clinical development paradigm for chemotherapeutic agents has significantly
influenced the development of therapeutic cancer vaccines. However, there are major
differences between these two classes of therapeutics that have important implications for
early clinical development. Specifically, the phase 1 concept of dose escalation to find a
maximum-tolerated dose does not apply to most therapeutic cancer vaccines. Most therapeutic
cancer vaccines are associated with minimal toxicity at a range that is feasible to
manufacture or administer, and there is little reason to believe that the maximum-tolerated
dose is the most effective dose.
In a recent article from the biostatistics literature, Simon et al. write that "the initial
clinical trial of many new vaccines will not be a toxicity or dose-ranging trial but rather
will involve administration of a fixed dose of vaccine … in most cases the dose selected will
be based on preclinical findings or practical considerations. Using several dose levels in
the initial study to find the minimal active dose or to characterize the dose-activity
relationship is generally not realistic".
Consistent with these recommendations, the general philosophy of the phase 1 clinical trial
is to facilitate a prompt preliminary evaluation of the safety and immunogenicity of the
personalized synthetic long peptide vaccine strategy. The proposed clinical trial will test a
fixed dose of vaccine. There is considerable experience with the synthetic long peptide
vaccine platform. The synthetic long peptide vaccine platform has an excellent safety
profile, and the optimal dose appears to be based on practical considerations (solubility of
the peptide). The dose to be tested in the proposed clinical trial is consistent with other
similar cancer vaccine trials that have been recently completed or are currently ongoing. The
sample size (n=10) will provide a reasonably reliable estimate of the safety and
immunogenicity of the vaccine.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05023551 -
Study of DSP-0390 in Patients With Recurrent High-Grade Glioma
|
Early Phase 1 | |
Recruiting |
NCT06059690 -
Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells
|
Phase 1/Phase 2 | |
Recruiting |
NCT04116411 -
A Clinical Trial Evaluating the Efficacy of Valganciclovir in Glioblastoma Patients
|
Phase 2 | |
Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Completed |
NCT02386826 -
INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
|
Phase 1 | |
Completed |
NCT00038493 -
Temozolomide and SCH66336 for Recurrent Glioblastoma Multiforme
|
Phase 2 | |
Withdrawn |
NCT03980249 -
Anti-Cancer Effects of Carvedilol With Standard Treatment in Glioblastoma and Response of Peripheral Glioma Circulating Tumor Cells
|
Early Phase 1 | |
Recruiting |
NCT01923922 -
CT Perfusion in the Prognostication of Cerebral High Grade Glioma
|
N/A | |
Completed |
NCT01956734 -
Virus DNX2401 and Temozolomide in Recurrent Glioblastoma
|
Phase 1 | |
Completed |
NCT01402063 -
PPX and Concurrent Radiation for Newly Diagnosed Glioblastoma Without MGMT Methylation
|
Phase 2 | |
Suspended |
NCT01386710 -
Repeated Super-selective Intraarterial Cerebral Infusion Of Bevacizumab Plus Carboplatin For Treatment Of Relapsed/Refractory GBM And Anaplastic Astrocytoma
|
Phase 1/Phase 2 | |
Completed |
NCT01301430 -
Parvovirus H-1 (ParvOryx) in Patients With Progressive Primary or Recurrent Glioblastoma Multiforme.
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT00995007 -
A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas
|
Phase 2 | |
Terminated |
NCT00990496 -
A Study Using Allogenic-Cytomegalovirus (CMV) Specific Cells for Glioblastoma Multiforme (GBM)
|
Phase 1 | |
Terminated |
NCT01044966 -
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT00402116 -
Phase 1/2 Study of Enzastaurin in Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma (GS) Patients
|
Phase 1/Phase 2 | |
Completed |
NCT00112502 -
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
|
Phase 2 | |
Completed |
NCT00504660 -
6-TG, Capecitabine and Celecoxib Plus TMZ or CCNU for Anaplastic Glioma Patients
|
Phase 2 | |
Recruiting |
NCT05366179 -
Autologous CAR-T Cells Targeting B7-H3 in Recurrent or Refractory GBM CAR.B7-H3Tc
|
Phase 1 |