Ignite Creation Date:
2025-12-24 @ 5:12 PM
Ignite Modification Date:
2026-01-02 @ 7:03 AM
Study NCT ID:
NCT03535350
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-30
First Post:
2018-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
Phase I Study of Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-01
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:
Safety of combination of ibrutinib and radiation at various dose levels in unmethylated o6-methylguanine-DNA-methyltransferase (MGMT) glioblastoma and study of ibrutinib, temozolomide, and radiation combination therapy in methylated MGMT glioblastoma.
Detailed Description:
There are a number of brain tumor studies including those in NCI consortium that are not including temozolomide for increased toxicity with novel agents or other drugs when added to temozolomide and radiation. However, if the combination of ibrutinib and radiation in unmethylated MGMT glioblastoma patient population is safe at every dose level we can study the safety of ibrutinib, radiation and Temozolomide in the methylated patient population. Concomitant use of radiation will lead to break down of the blood brain barrier and increase ibrutinib delivery to the brain tumor and hence the rationale to combine ibrutinib with radiation with or without temozolomide.
November 2020:
420 mg of ibrutinib plus temozolomide and radiation was found to be safe - up to 36 participants can be treated at the expansion cohort in both arm 1 and arm 2.
November 2020:
420 mg of ibrutinib plus temozolomide and radiation was found to be safe - up to 36 participants can be treated at the expansion cohort in both arm 1 and arm 2.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: