GliomaPhase 1NCT03514069
Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma
A Phase 1 study testing ruxolitinib, radiation and temozolomide in people with Glioma and Glioblastoma, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma
- What is being tested?
- ruxolitinib, radiation and temozolomide
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2018to 29 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Phase I Study of Ruxolitinib With Radiation and Temozolomide in Patients With Newly Diagnosed Grade III Gliomas and Glioblastoma
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.
Read the detailed description
Primary Objective
Arm 1:
To determine Maximum tolerated dose (MTD) of ruxolitinib with radiation (2 Gy x 30) in patients with unmethylated MGMT high-grade glioma (HGG)
Arm 2:
To determine Maximum tolerated dose (MTD) of ruxolitinib with radiation (2 Gy x 30) and daily temozolomide at 75 mg/m2 in patients with methylated MGMT high-grade glioma (HGG)
Secondary Objective(s)
Arm 1:
- Safety of combination of ruxolitinib with radiation
- Progression free survival (PFS)
- Overall survival (OS)
Arm 2:
- Safety of combination of ruxolitinib with radiation and temozolomide
- Progression free survival (PFS)
- Overall survival (OS)
STUDY DESIGN
A phase 1 design will be used with cohorts of 3 patients treated at each dose level in both arms 1 and 2 and monitored for treatment-related toxicities. Escalation to the next dose will proceed in the absence of dose-limiting toxicities (DLTs).
- Conditions
- Glioma, Glioblastoma
- Being tested
- ruxolitinib, radiation, temozolomide
- Keywords
- ruxolitinib, radiation, temozolomide
- Medical subject headings
- Glioma, Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ruxolitinibDrug
Starting dose ruxolitinib 10 mg twice daily
radiationRadiation
60gy for 6 weeks
temozolomideDrug
75mg/m2
| Study group | Role | What they receive |
|---|---|---|
| ruxolitinib + radiation x 60 Gy for 6 weeks | Experimental | 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 Receives: Drug: ruxolitinib; Radiation: radiation |
| ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m | Experimental | 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 Receives: Drug: ruxolitinib; Radiation: radiation; Drug: temozolomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) of ruxolitinib with radiation in study patients
Measured: Up to 6 weeks
Maximum tolerated dose (MTD) of ruxolitinib with radiation and daily Temozolomide in study patients
Measured: Up to 6 weeks
Secondary outcomes (3)
Number of patient study specific adverse events as a measure of safety
Study specific adverse events are defined as any of the following events occurring during the first 8 weeks of treatment with ruxolitinib and while being given radiation/temozolomide: grade 3 or 4 low platelets, grade 4 low red blood cells, grade 4 low white blood cells lasting more than a week, fever, any non-blood related side effect of grade 3 or greater (excluding hair loss) despite treatment, grade 4 radiation-related skin changes, and any episode of noninfectious pneumonitis.
Measured: Up to 8 weeks after beginning treatment
Number of patients who have experienced progression free survival as defined by the response assessment in neuro-oncology (RANO) criteria
Measured: Up to 6 weeks
Average time patients stayed alive on study
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start5 Jun 2018
- Primary completion27 Aug 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Peereboom, MD, Principal investigator, Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514069
- Sponsor's protocol ID
- CASE3317
- Status last verified
- Jun 2026
- First submitted
- 20 Apr 2018
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Ruxolitinib With Radiation and Temozolomide in Patients With Newly Diagnosed Grade III Gliomas and Glioblastoma
- ClinicalTrials.gov ID
- NCT03514069
- Acronym / sponsor ID
- CASE3317
- Conditions
- Glioma, Glioblastoma
- Keywords
- ruxolitinib, radiation, temozolomide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 2 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective
Arm 1:
To determine Maximum tolerated dose (MTD) of ruxolitinib with radiation (2 Gy x 30) in patients with unmethylated MGMT high-grade glioma (HGG)
Arm 2:
To determine Maximum tolerated dose (MTD) of ruxolitinib with radiation (2 Gy x 30) and daily temozolomide at 75 mg/m2 in patients with methylated MGMT high-grade glioma (HGG)
Secondary Objective(s)
Arm 1:
- Safety of combination of ruxolitinib with radiation
- Progression free survival (PFS)
- Overall survival (OS)
Arm 2:
- Safety of combination of ruxolitinib with radiation and temozolomide
- Progression free survival (PFS)
- Overall survival (OS)
STUDY DESIGN
A phase 1 design will be used with cohorts of 3 patients treated at each dose level in both arms 1 and 2 and monitored for treatment-related toxicities. Escalation to the next dose will proceed in the absence of dose-limiting toxicities (DLTs).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ruxolitinib + radiation x 60 Gy for 6 weeks | Experimental | Drug: ruxolitinib, Radiation: radiationUnmethylated 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 |
| ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m | Experimental | Drug: ruxolitinib, Radiation: radiation, Drug: temozolomideMethylated 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have unmethylated MGMT supratentorial high-grade glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or glioblastoma).
- Patients must have supratentorial methylated MGMT high-grade glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed astro oligodendroglioma or glioblastoma).
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ruxolitinibStarting dose ruxolitinib 10 mg twice daily | Drug | ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m, ruxolitinib + radiation x 60 Gy for 6 weeks |
| radiation60gy for 6 weeks | Radiation | ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m, ruxolitinib + radiation x 60 Gy for 6 weeks |
| temozolomide75mg/m2 | Drug | ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m |
Primary outcome
Maximum tolerated dose (MTD) of ruxolitinib with radiation in study patients
Time frame: Up to 6 weeks
Maximum tolerated dose (MTD) of ruxolitinib with radiation and daily Temozolomide in study patients
Time frame: Up to 6 weeks
3 secondary outcomes
Number of patient study specific adverse events as a measure of safety
Time frame: Up to 8 weeks after beginning treatment
Number of patients who have experienced progression free survival as defined by the response assessment in neuro-oncology (RANO) criteria
Time frame: Up to 6 weeks
Average time patients stayed alive on study
Time frame: Up to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Peereboom, MD principal investigator
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ruxolitinib, radiation and temozolomide in people with Glioma and Glioblastoma, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) of ruxolitinib with radiation in study patients (time frame: Up to 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.