Active — Not RecruitingPhase 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 range18 Years

SexALL

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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…

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