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Experimental drug ruxolitinib joins standard therapy in brain cancer battle

NCT ID NCT03514069

Disease control Sponsor: Case Comprehensive Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-phase study tested whether adding the experimental drug ruxolitinib to standard radiation and chemotherapy (temozolomide) is safe for people with newly diagnosed high-grade gliomas or glioblastoma. Ruxolitinib targets proteins that help cancer cells grow. The study enrolled 60 participants and focused on finding the best dose and monitoring side effects. It is a first step toward possibly improving treatment for these aggressive brain tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ruxolitinib
What this could lead to
If successful, this could point toward a new combination treatment for aggressive brain cancers like glioblastoma.
What could go wrong
This is an early Phase 1 safety and dosing study with only 60 participants. The drug may not improve outcomes or could cause side effects like low blood cell counts.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

60 people

The number who actually took part.

Started

Jun 2018

Finished

Sep 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 radiation therapy and temozolomide treatment. * Patients who have previously received other treatments for their cancers * Patient has previously taken ruxolitinib or is allergic to components of the study drug * Use of blood thinners * Human immunodeficiency virus (HIV) infection * Active hepatitis B or C infection * Heart diseases including abnormal electrocardiogram (EKG) * Patients unwilling or unable to follow this protocol

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Conditions

The condition(s) this trial relates to.

anaplastic astrocytoma anaplastic oligoastrocytoma anaplastic oligodendroglioma glioblastoma glioma malignant glioma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glioblastoma GLIOMA

Contacts and locations

Locations

  • Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, 44195, United States

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