Ignite Creation Date:
2024-05-06 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 12:40 PM
Study NCT ID:
NCT03426891
Status:
COMPLETED
Last Update Posted:
2023-07-19
First Post:
2018-02-02
Brief Title:
Pembrolizumab and Vorinostat Combined With Temozolomide for Newly Diagnosed Glioblastoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase I Trial of Pembrolizumab and Vorinostat Combined With Temozolomide and Radiation Therapy for Newly Diagnosed Glioblastoma
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this research study is to test the safety and tolerability of the combination treatment of the investigational drugs vorinostat and pembrolizumab in combination with chemotherapy temozolomide and radiotherapy The US Food and Drug Administration FDA has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers However both vorinostat and pembrolizumab are considered investigational drugs in this study because they are not approved for treatment of glioblastoma
Detailed Description:
There are 2 parts to this study
Part 1 dose escalation and Part 2 dose expansion The main purpose of Part 1 is Dose-Escalation Dose-Escalation means that different dose levels will be tested at different times during the study to find the best dose level that is safe and well tolerated in participants In this study investigators will determine the best dose of Vorinostat that can be given with pembrolizumab chemotherapy and radiotherapy The dose of temozolomide and radiotherapy will be the same as standard treatment
Part 2 Dose Expansion all participants will receive the same dose of vorinostat with pembrolizumab chemotherapy and radiotherapy
Maintenance Phase During the maintenance phase participants will receive Temozolomide for the first 6 months vorinostat for 12 months and pembrolizumab for 12 months
Part 1 dose escalation and Part 2 dose expansion The main purpose of Part 1 is Dose-Escalation Dose-Escalation means that different dose levels will be tested at different times during the study to find the best dose level that is safe and well tolerated in participants In this study investigators will determine the best dose of Vorinostat that can be given with pembrolizumab chemotherapy and radiotherapy The dose of temozolomide and radiotherapy will be the same as standard treatment
Part 2 Dose Expansion all participants will receive the same dose of vorinostat with pembrolizumab chemotherapy and radiotherapy
Maintenance Phase During the maintenance phase participants will receive Temozolomide for the first 6 months vorinostat for 12 months and pembrolizumab for 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None