Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma

NCT03514069 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CASE3317
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma; Glioblastoma

Keywords

ruxolitinib; radiation; temozolomide

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose (MTD) of ruxolitinib with radiation in study patients

  Up to 6 weeks

• Maximum tolerated dose (MTD) of ruxolitinib with radiation and daily Temozolomide in study patients

  Up to 6 weeks

Secondary Outcomes (3)

• Number of patient study specific adverse events as a measure of safety

  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

  Up to 6 weeks

• Average time patients stayed alive on study

  Up to 6 weeks

Study Arms (2)

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

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

Drug: ruxolitinib; Radiation: radiation; Drug: temozolomide

Interventions

ruxolitinib DRUG

Starting dose ruxolitinib 10 mg twice daily

ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m; ruxolitinib + radiation x 60 Gy for 6 weeks

temozolomide DRUG

75mg/m2

ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m

radiation RADIATION

60gy for 6 weeks

ruxolitinib + radiation x 60 Gy + temozolomide 75 mg/m; ruxolitinib + radiation x 60 Gy for 6 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Glioma; Glioblastoma

Interventions

ruxolitinib; Radiation; Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Astrocytoma

Intervention Hierarchy (Ancestors)

Physical Phenomena; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• David Peereboom, MD

  Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 2, 2018
• Study Start: June 5, 2018
• Primary Completion: August 27, 2021
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (1)