Astrocytoma Clinical Trial
Official title:
A Pilot Study to Evaluate the Effects of Vaccinations With HLA-A2-Restricted Glioma Antigen-Peptides in Combination With Poly-ICLC for Adults With Recurrent WHO Grade II Gliomas
This is a pilot vaccine study in adults with recurrent WHO Grade II gliomas. The purpose of
this study is to test the safety and efficacy of an experimental tumor vaccine made from
peptides in combination with the study drug Poly-ICLC.
Poly-ICLC, manufactured by Oncovir, Inc., has already been received and is generally well
tolerated by subjects in earlier studies and has been shown to decrease the size of brain
tumors in some cases.
The immunological and safety data will be used to decide whether a larger study of clinical
efficacy is warranted.
This is a pilot study of a vaccination regime that is designed to efficiently induce
anti-tumor T-cell responses in patients with recurrent WHO grade II glioma. The proposed
regime combines subcutaneous injections of glioma-associated antigen (GAA)-derived cytotoxic
T-lymphocyte (CTL) epitope-peptides with simultaneous intramuscular (i.m.) administration of
poly-ICLC.
The overall objective of this pilot study is to collect immunological and safety data that
will be used to decide whether a larger study of clinical efficacy is warranted in these
patients. All patients on the study will be followed for a minimum of 2 years, so that the
actual 2-year overall survival (OS), 6-month and 2-year progression-free survival (PFS)
rates can be determined in an exploratory manner.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02764151 -
First in Patient Study for PF-06840003 in Malignant Gliomas
|
Phase 1 | |
Completed |
NCT00994071 -
A Phase I Study of ABT-888, an Oral Inhibitor of Poly(ADP-ribose) Polymerase and Temozolomide in Children With Recurrent/Refractory CNS Tumors
|
Phase 1 | |
Completed |
NCT02903784 -
Neural Basis of Language Processing
|
N/A | |
Terminated |
NCT01502605 -
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
|
Phase 1 | |
Terminated |
NCT01044966 -
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
|
Phase 1/Phase 2 | |
Completed |
NCT00705198 -
Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)
|
N/A | |
Completed |
NCT00165360 -
Prolonged Daily Temozolomide for Low-Grade Glioma
|
Phase 2 | |
Active, not recruiting |
NCT03911388 -
HSV G207 in Children With Recurrent or Refractory Cerebellar Brain Tumors
|
Phase 1 | |
Terminated |
NCT00389090 -
A Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma
|
Phase 2 | |
Completed |
NCT00154375 -
Study of Imatinib Mesylate in Combination With Hydroxyurea Versus Hydroxyurea Alone as an Oral Therapy in Patients With Temozolomide Resistant Progressive Glioblastoma
|
Phase 3 | |
Completed |
NCT00001148 -
Detecting Malignant Brain Tumor Cells in the Bloodstream During Surgery to Remove the Tumor
|
N/A | |
Completed |
NCT03722355 -
Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma
|
Phase 3 | |
Recruiting |
NCT03975829 -
Pediatric Long-Term Follow-up and Rollover Study
|
Phase 4 | |
Recruiting |
NCT05686798 -
Adenovirus Mediated Suicide Gene Therapy With Radiotherapy in Progressive Astrocytoma.
|
Phase 1 | |
Active, not recruiting |
NCT03739372 -
Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for Patients With High Grade Glioma
|
N/A | |
Recruiting |
NCT05624736 -
Hierarchical Diagnosis for Adult Diffuse Glioma Based on Deep Learning
|
||
Recruiting |
NCT05345002 -
All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
|
Phase 2 | |
Recruiting |
NCT04028479 -
The Registry of Oncology Outcomes Associated With Testing and Treatment
|
||
Completed |
NCT00783393 -
SCH 52365 Phase II Clinical Study: A Study on the Efficacy and Safety of Monotherapy With SCH 52365 in Patients With First Relapsed Anaplastic Astrocytoma (Study P03745)
|
Phase 2 | |
Completed |
NCT03900689 -
Social Determinants of Health in Glioblastoma Population
|