Spots Global Cancer Trial Database for Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma

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Trial Identification

Brief Title: Ibrutinib With Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma

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

Study ID: NCT03535350

Conditions

Glioblastoma

Interventions

Ibrutinib

Radiation

Temozolomide (TMZ)

Study Description

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.