Study on Ruxolitinib with Radiation and Temozolomide for Newly Diagnosed Glioblastoma

Sponsor: Baptist Health South Florida

Sponsor score: 0

ClinicalTrials ID:NCT06991101

This clinical trial is testing whether adding the investigational drug ruxolitinib to the standard treatment of radiation and temozolomide can improve outcomes for patients with newly diagnosed glioblastoma. Participants will be randomly assigned to receive either the standard treatment alone or with the addition of ruxolitinib.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of adding the investigational drug ruxolitinib to the standard treatment of radiation therapy and temozolomide for patients with newly diagnosed glioblastoma. Glioblastoma is a type of brain cancer. Participants will be randomly assigned to one of two groups: one group will receive the standard treatment of radiation and temozolomide, while the other group will receive the same standard treatment plus ruxolitinib. This random assignment is like flipping a coin, ensuring each participant has an equal chance of being in either group.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed consent to participate in the study.
  • Willingness to follow all study procedures and be available for the study duration.
  • Open to adults of any gender, race, or ethnicity aged 18 and older.
  • Must have a confirmed diagnosis of glioblastoma, a type of brain cancer, as per WHO 2021 criteria.
  • Must have enough tissue available for specific genetic testing required by the study.
  • Must be able to care for themselves with occasional help, as measured by a performance status score of 70% or higher.
  • Must have adequate liver, kidney, and bone marrow function based on recent blood tests.
  • Women who can become pregnant must use effective birth control starting one month before the study and have a negative pregnancy test.
  • No other active cancers, except for certain early-stage cancers that have been treated and are in remission for at least 3 years.

Exclusion Criteria

  • Women who are pregnant or breastfeeding cannot participate due to potential risks to the baby.
  • Cannot be receiving other treatments for the brain tumor during the study.
  • Cannot have other active cancers unless they are certain types that have been treated and are in remission for at least 3 years.
  • Cannot have had multiple brain surgeries after receiving radiation and temozolomide.
  • Cannot have taken other cancer drugs or experimental treatments alongside radiation and temozolomide.
  • Cannot have taken ruxolitinib before or be allergic to it.
  • Cannot be using the blood thinner warfarin.
  • Cannot have uncontrolled HIV or active tuberculosis.
  • Cannot have serious infections requiring treatment.
  • Cannot have active hepatitis B or C infections that need treatment.
  • Cannot have significant heart problems or recent serious heart events.
  • Cannot have any other serious medical or psychiatric conditions that would interfere with the study.

Locations

FACILITYZIPCITYSTATE
Miami Cancer Institute at Baptist Health, Inc.33176MiamiFlorida

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