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Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03514069
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Case Comprehensive Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 David Peereboom, MD
Principal Investigator Affiliation Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Active, not recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma, Glioblastoma
Additional Details

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).

Arms & Interventions

Arms

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

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

Interventions

Drug: - ruxolitinib

Starting dose ruxolitinib 10 mg twice daily

Radiation: - radiation

60gy for 6 weeks

Drug: - temozolomide

75mg/m2

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Cleveland, Ohio

Status

Address

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195

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