Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03514069 |
Recruitment Status :
Recruiting
First Posted : May 2, 2018
Last Update Posted : January 25, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioma Glioblastoma | Drug: ruxolitinib Radiation: radiation Drug: temozolomide | Phase 1 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I Study of Ruxolitinib With Radiation and Temozolomide in Patients With Newly Diagnosed Grade III Gliomas and Glioblastoma |
Actual Study Start Date : | June 5, 2018 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | December 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: ruxolitinib + radiation x 60 Gy for 6 weeks
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
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Drug: ruxolitinib
Starting dose ruxolitinib 10 mg twice daily Radiation: radiation 60gy for 6 weeks |
Experimental: ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m
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 |
Drug: ruxolitinib
Starting dose ruxolitinib 10 mg twice daily Radiation: radiation 60gy for 6 weeks Drug: temozolomide 75mg/m2 |
- 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 ]
- Number of patient study specific adverse events as a measure of safety [ Time Frame: Up to 8 weeks after beginning treatment ]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.
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514069
Contact: David Peereboom, MD | 1-866-223-8100 | TaussigResearch@ccf.org |
United States, Ohio | |
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: David Peereboom, MD 866-223-8100 TaussigResearch@ccf.org | |
Principal Investigator: David Peereboom, MD |
Principal Investigator: | David Peereboom, MD | Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center |
Responsible Party: | Case Comprehensive Cancer Center |
ClinicalTrials.gov Identifier: | NCT03514069 |
Other Study ID Numbers: |
CASE3317 |
First Posted: | May 2, 2018 Key Record Dates |
Last Update Posted: | January 25, 2022 |
Last Verified: | January 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
ruxolitinib radiation temozolomide |
Glioblastoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |