Ruxolitinib With Radiation and Temozolomide for Grade III Gliomas and Glioblastoma

  • STATUS
    Recruiting
  • days left to enroll
    86
  • participants needed
    36
  • sponsor
    Case Comprehensive Cancer Center
Updated on 12 June 2021
cancer
karnofsky performance status
MRI
tumor cells
glioblastoma multiforme
temozolomide
astrocytoma
malignant glioma
brain tumor
oligodendroglioma
anaplastic astrocytoma
anaplastic oligodendroglioma
astrocytoma, anaplastic
malignant brain tumor
oligodendroglioma, anaplastic
methylated

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.

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).

Details
Condition Glioma, Glioblastoma Multiforme, Gliomas, glioblastoma, glial tumor
Treatment Ruxolitinib, Temozolomide, Radiation
Clinical Study IdentifierNCT03514069
SponsorCase Comprehensive Cancer Center
Last Modified on12 June 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note