NCT03514069

Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma

Phase I Study of Ruxolitinib With Radiation and Temozolomide in Patients With Newly Diagnosed Grade III Gliomas and Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test how well the drug works, safety and tolerability of an investigational drug called Ruxolitinib in gliomas and glioblastomas, when combined with standard treatment for brain cancer, temozolomide and radiation. Ruxolitinib is an experimental drug that works by targeting proteins in cells and stops them from growing. Ruxolitinib is experimental because it is not approved by the Food and Drug Administration (FDA) for the treatment of gliomas or glioblastomas Temozolomide works by damaging the DNA of tumor cells so that they cannot divide properly. Some tumor cells can repair that damage and therefore be resistant to temozolomide.

Detailed description

Primary Objective Arm 1: To determine Maximum tolerated dose (MTD) of ruxolitinib with radiation (2 Gy x 30) in patients with unmethylated MGMT high-grade glioma (HGG) Arm 2: To determine Maximum tolerated dose (MTD) of ruxolitinib with radiation (2 Gy x 30) and daily temozolomide at 75 mg/m2 in patients with methylated MGMT high-grade glioma (HGG) Secondary Objective(s) Arm 1: * Safety of combination of ruxolitinib with radiation * Progression free survival (PFS) * Overall survival (OS) Arm 2: * Safety of combination of ruxolitinib with radiation and temozolomide * Progression free survival (PFS) * Overall survival (OS) STUDY DESIGN A phase 1 design will be used with cohorts of 3 patients treated at each dose level in both arms 1 and 2 and monitored for treatment-related toxicities. Escalation to the next dose will proceed in the absence of dose-limiting toxicities (DLTs).

Conditions

• Glioma
• Glioblastoma

Interventions

Type	Name	Description
DRUG	ruxolitinib	Starting dose ruxolitinib 10 mg twice daily
RADIATION	radiation	60gy for 6 weeks
DRUG	temozolomide	75mg/m2

Timeline

• Start date: 2018-06-05
• Primary completion: 2021-08-27
• Completion: 2026-05-31
• First posted: 2018-05-02
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study