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Ruxolitinib + Temozolomide + Radiation for Glioblastoma

Phase 1
Waitlist Available
Led By David Peereboom, MD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Arm 2: Patients must have supratentorial methylated MGMT high-grade glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or glioblastoma)
Arm 1: Patients must have unmethylated MGMT supratentorial high-grade glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or glioblastoma)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 weeks after beginning treatment
Awards & highlights

Study Summary

This trial is testing how well Ruxolitinib works with temozolomide and radiation to treat patients with gliomas or glioblastomas.

Who is the study for?
This trial is for adults with certain high-grade brain tumors (gliomas or glioblastoma) that haven't spread beyond a specific area and have not been treated before. Participants need to be fairly independent, able to consent, and willing to use birth control. They can't join if they have other serious illnesses, HIV, hepatitis B/C, heart issues, are pregnant or on blood thinners.Check my eligibility
What is being tested?
The study tests Ruxolitinib's effectiveness when combined with standard brain cancer treatments: radiation and Temozolomide. Ruxolitinib targets cell proteins to stop tumor growth but isn't FDA-approved yet for these cancers. Temozolomide damages tumor DNA.See study design
What are the potential side effects?
Ruxolitinib may cause infections due to immune system effects, bleeding problems from low platelets, anemia from low red blood cells count; liver function changes; cholesterol level changes; headaches; dizziness and fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a specific type of brain tumor with a certain genetic feature.
Select...
My brain tumor is a high-grade type and tests show it is unmethylated.
Select...
I can take care of myself with a little help from others.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 weeks after beginning treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks after beginning treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Temozolomide
Therapeutic radiology procedure
Secondary outcome measures
Average time patients stayed alive on study
Number of patient study specific adverse events as a measure of safety
Number of patients who have experienced progression free survival as defined by the response assessment in neuro-oncology (RANO) criteria

Side effects data

From 2022 Phase 3 trial • 458 Patients • NCT04530344
13%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib 1.5% Cream BID
Total
Vehicle Cream BID

Trial Design

2Treatment groups
Experimental Treatment
Group I: ruxolitinib + radiation x 60 Gy for 6 weeksExperimental Treatment2 Interventions
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
Group II: ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/mExperimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
radiation
2014
Completed Phase 3
~1440
temozolomide
2008
Completed Phase 2
~1060
ruxolitinib
2017
Completed Phase 3
~600

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
455 Previous Clinical Trials
31,769 Total Patients Enrolled
David Peereboom, MDPrincipal InvestigatorCleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
9 Previous Clinical Trials
343 Total Patients Enrolled

Media Library

Radiation Clinical Trial Eligibility Overview. Trial Name: NCT03514069 — Phase 1
Brain Tumor Research Study Groups: ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m, ruxolitinib + radiation x 60 Gy for 6 weeks
Brain Tumor Clinical Trial 2023: Radiation Highlights & Side Effects. Trial Name: NCT03514069 — Phase 1
Radiation 2023 Treatment Timeline for Medical Study. Trial Name: NCT03514069 — Phase 1
~1 spots leftby Jun 2024
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