CTNI-16. FEASIBILITY PILOT STUDY OF OKN-007 IN COMBINATION WITH ADJUVANT TEMOZOLOMIDE CHEMORADIOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA

ABSTRACT: Abstract

BACKGROUND

Temozolomide (TMZ) is the standard of care chemotherapy agent for glioblastoma. Unfortunately, intrinsic or acquired resistance eventually renders TMZ ineffective. The novel anti-cancer agent OKN-007 plus TMZ increased survival in glioma-bearing mice compared to TMZ alone. Furthermore, OKN-007 increased TMZ sensitivity in both TMZ-sensitive and TMZ-resistant cell lines. Therefore, we initiated a clinical trial (NCT03587038) of OKN-007 in combination with TMZ and radiation therapy (RT). Here we report the safety and tolerability findings of this trial in-progress.

METHODS

Adults with newly-diagnosed and resected GBM are eligible. OKN-007 is administered by IV at 60 mg/kg. There are three treatment phases: Concomitant, Pre-Maintenance, and Maintenance. I

SUBMITTER: Battiste J 

PROVIDER: S-EPMC7650353 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature