Ruxolitinib + Standard Treatment for Brain Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new combination treatment for individuals recently diagnosed with glioblastoma, a type of brain cancer. Researchers aim to determine if adding the drug ruxolitinib to standard treatments, such as radiation and temozolomide (a chemotherapy drug), can be safe and more effective. Participants will receive either the standard treatment with or without ruxolitinib, assigned randomly. Ideal candidates have a confirmed glioblastoma diagnosis and require some assistance with daily activities. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using warfarin or receiving other treatments for your brain tumor. It's best to discuss your current medications with the study team to see if they might affect your eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that ruxolitinib, when combined with radiation and temozolomide, is generally well-tolerated by patients. One study found that taking 20 mg of ruxolitinib twice a day is safe alongside these treatments and demonstrated promising survival rates compared to past results. Ruxolitinib has been used for over ten years for other conditions, and its safety is well-established. Most people can take it with or without food, and it leaves the body quickly, reducing the risk of long-lasting side effects.
Overall, evidence suggests that ruxolitinib is generally safe when used with standard brain cancer treatments like radiation and temozolomide.12345Why do researchers think this study treatment might be promising for brain cancer?
Ruxolitinib is unique because it works by targeting the JAK-STAT signaling pathway, which is often overactive in brain cancer cells. This is different from the standard treatments like temozolomide and radiation, which primarily focus on damaging the DNA of cancer cells. By specifically inhibiting this pathway, ruxolitinib may help to slow down or stop the growth of cancer cells more effectively. Researchers are excited because this targeted approach could potentially improve outcomes for patients with brain cancer, offering a new avenue of hope beyond traditional methods.
What evidence suggests that this trial's treatments could be effective for glioblastoma?
This trial will compare the effectiveness of adding ruxolitinib to the standard glioblastoma treatment, which includes radiation and temozolomide. Research has shown that patients receiving ruxolitinib with radiation and temozolomide lived longer without cancer progression and had longer overall survival compared to those receiving only the standard treatment. This combination has also proven safe and manageable for patients. These findings offer hope that ruxolitinib could enhance the effectiveness of current glioblastoma treatments.678910
Who Is on the Research Team?
Manmeet Ahluwalia, M.D., MBA
Principal Investigator
Miami Cancer Institute at Baptist Health, Inc.
Are You a Good Fit for This Trial?
This trial is for individuals newly diagnosed with glioblastoma, a type of brain cancer. Participants should not have received prior treatments for this condition. Specific eligibility criteria are not provided, but typically include factors like age, overall health status, and the stage of the tumor.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Radiation and Temozolomide
Participants receive radiation therapy and temozolomide, with or without ruxolitinib, during this phase
Maintenance
Participants continue with temozolomide, with or without ruxolitinib, after radiation therapy is complete
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Radiation Therapy
- Ruxolitinib
- Temozolomide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baptist Health South Florida
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
Hervé Hoppenot
Incyte Corporation
Chief Executive Officer since 2014
MBA from ESSEC Business School