CompletedPhase 1

Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma

United States60 participantsStarted 2018-06-05

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Arm 1: * Patients must have unmethylated MGMT supratentorial high-grade glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or glioblastoma). Arm 2: * Patients must have supratentorial methylated MGMT high-grade glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or glioblastoma). Both: * Patients must have MRI or CT with contrast within 28 days prior to starting treatment. * Patients must have a Karnofsky performance status ≥ 70% (i.e. the patient must be able to care for himself/herself with occasional help from others). * Patients must have adequate blood, kidney and liver function * Patients must be able to provide written informed consent. * Patients and their sexual partners must agree to avoid conception while on the study due to possible risks from experimental drugs. Women will need a negative pregnancy test to be on the study * Patients may not have any other cancers except skin cancer and localized bladder, prostate, cervical, or breast cancer which were cured more than 3 years ago Exclusion Criteria: * Patients with other serious diseases * Pregnant women * Patients getting other cancer treatments * Patients with other cancers except for localized skin cancer and localized bladder, prostate, cervical, or breast cancer which were cured more than 3 years ago * Patients who have had repeat craniotomy for tumor therapy after receiving radia…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 1 trial that has already completed, it was primarily designed to find a safe dose rather than prove the treatment works — so what, if anything, did the results show about whether ruxolitinib combined with radiation and temozolomide appeared safe or showed any early signs of benefit for glioblastoma or Grade III glioma?
2Because this trial is completed and no longer enrolling, are there any follow-on Phase 2 trials or similar studies testing ruxolitinib for my type of brain tumor that I might be eligible for now?
3How does adding ruxolitinib — a JAK inhibitor not typically used for brain tumors — to standard radiation and temozolomide change the side effect profile compared to the standard treatment alone, based on what this trial found?
4For my specific diagnosis — whether it's glioblastoma or a Grade III glioma — would you recommend standard radiation and temozolomide first, or is there a reason to consider an experimental combination like the one tested in this trial?
5Since this trial has finished, is the data from it published or available, and would reviewing those results change how you'd approach my treatment plan?'

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum tolerated dose (MTD) of ruxolitinib with radiation in study patients

Timeframe: Up to 6 weeks

Maximum tolerated dose (MTD) of ruxolitinib with radiation and daily Temozolomide in study patients

Timeframe: Up to 6 weeks

Trial details

NCT IDNCT03514069

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-08-27

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