Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glioblastoma
- Glioma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 pat...
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).
Tracking Information
- NCT #
- NCT03514069
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: David Peereboom, MD Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
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