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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks after beginning treatment

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%

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

452 Previous Clinical Trials

31,850 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any past experiments concerning ruxolitinib?

"Presently, the clinical landscape features 302 studies involving ruxolitinib. 35 of those trials have advanced to Phase 3. Most research is done in Houston, Texas yet 7949 sites are currently running tests for this medication."

Answered by AI

Is this an innovative trial with never-before tested methods?

"The earliest research into ruxolitinib began in 2002, with a Phase 2 trial sponsored by Schering-Plough. After this initial study involving 60 participants, the drug was approved and today there are 302 live trials across 1257 cities located in 54 nations."

Answered by AI

In what medical situations is ruxolitinib typically recommended?

"Ruxolitinib is a commonly prescribed therapy for anaplastic astrocytoma, but it has several other applications such as halting the progression of certain types of cancer and treating nitrosourea induced illness."

Answered by AI

Is enrollment for this research still available to participants?

"The recruitment window for this clinical trial has closed. It was announced on June 5th 2018 and the last update occured on October 31st 2022. For those looking to participate in other trials, there are currently 708 studies for glioblastoma and 302 protocols using ruxolitinib that are actively enrolling patients."

Answered by AI

How many participants are taking part in this trial at its fullest capacity?

"Unfortunately, enrollment for this trial has been closed. It was initially posted in June 2018 and last edited in October 2022. For individuals looking to participate in other trials, there are 708 glioblastoma studies actively recruiting and 302 clinical studies concerning the drug ruxolitinib that have open spots."

Answered by AI

To what extent can ruxolitinib be detrimental to users?

"Due to its Phase 1 status, there is restricted evidence in regards to ruxolitinib's safety and efficacy. As such, our team at Power assigned it a score of 1 on the scale from one to three."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma

2018. "Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03514069.

All > Recurrent Glioblastoma > Glioma