Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT03514069
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ruxolitinib — DRUG
    Starting dose ruxolitinib 10 mg twice daily
  • radiation — RADIATION
    60gy for 6 weeks
  • temozolomide — DRUG
    75mg/m2

Study Details

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.

Key Dates

Start date
Jun 5, 2018
Status verified
Jun 2026
Primary completion
Aug 27, 2021
Completion
Sep 29, 2021

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ruxolitinib + radiation x 60 Gy for 6 weeks
    Unmethylated O6-methylguanine DNA methyltransferase (MGMT) Glioblastoma and grade III glioma Every patient gets ruxolitinib + radiation x 60 Gy for 6 weeks over 6 weeks. The dose of radiation therapy is fixed at 60 Gy over 6 weeks
  • Experimental: ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m
    Methylated MGMT Glioblastoma and grade III glioma. Arm 2 will start once the safe dose has been established for Arm 1 for every dose level. Every patient gets ruxolitinib + radiation x 60 Gy + daily temozolomide at 75 mg/m2 for 6 weeks over 6 weeks. The dose of radiation therapy is fixed at 60 Gy over 6 weeks (2 Gy x 30). The dose of temozolomide is 75 mg/m2 daily for 6 weeks

Primary Outcome Measure

Maximum tolerated dose (MTD) of ruxolitinib with radiation in study patients [ Time Frame: Up to 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer CenterClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center· Cleveland, OH

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