NCT03535350

Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma

Phase I Study of Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
DRUG	Ibrutinib	Dose response of Ibrutinib. Level 1 starting dose is 420mg daily. Level 2 starting dose is 560mg daily. Level -1 starting dose is 280mg daily. November 2020: 420 mg of ibrutinib plus temozolomide and radiation was found to be safe - up to 36 participants can betreated at the expansion cohort in both arm 1 and arm 2.
RADIATION	Radiation	2Gy x 30minutes for 6 weeks.
DRUG	Temozolomide (TMZ)	Cycle 1 150mg/m2 and cycle 2-6 will be up to 200mg/m2.

Timeline

• Start date: 2018-08-24
• Primary completion: 2023-04-04
• Completion: 2025-12-30
• First posted: 2018-05-24
• Last updated: 2025-09-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study