Study on Tofacitinib for Patients with Recurrent Glioblastoma

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05326464

Provider View

This clinical trial is exploring the effects of the drug Tofacitinib in patients whose glioblastoma, a type of brain cancer, has returned after initial treatment.

Patient Parameters

Program Overview

The aim of this study is to see how the drug Tofacitinib affects patients with glioblastoma that has come back after treatment. Participants will take Tofacitinib in 28-day cycles, with breaks between cycles. Regular assessments, including brain scans, will be conducted to monitor the tumor and any side effects. Treatment will continue until the cancer progresses, side effects become too severe, or the doctor decides it's not safe to continue.

Description

Once you agree to participate and are registered, you will start the first cycle of treatment with Tofacitinib. Each cycle lasts 28 days, during which you will take the medication continuously. There will be a break of 18-24 days between the first and following cycles. You will be assessed at the start of each cycle, and after the second cycle, you will have a brain MRI to measure the tumor and other health checks. This pattern will continue every 4 weeks. Treatment will stop if the cancer worsens, side effects are too severe, or your doctor advises against continuing.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with glioblastoma (GBM) that has returned after initial treatment, with specific genetic markers.
  • Tumor growth confirmed by imaging, with at least 12 weeks since last radiotherapy.
  • Able to perform daily activities with a Karnofsky Performance Status of 60% or higher.
  • Willing to provide written consent and follow study procedures.
  • Aged 18 years or older.
  • Able to swallow pills.
  • Women of childbearing age must use effective birth control during and for 6 months after treatment. Men must use barrier contraception during and for 6 months after treatment.
  • Recent surgery patients are eligible if the tumor recurrence is confirmed and the surgical site is healed.
  • Must have recovered from previous chemotherapy side effects.
  • Tumor must have a specific gene amplification.
  • Previous use of bevacizumab is allowed if stopped 180 days before.
  • Must have adequate blood and organ function based on specific lab tests.

Exclusion Criteria

  • Previous treatment with EGFR or JAK inhibitors.
  • Currently receiving other experimental cancer treatments.
  • Unable to have MRI scans with contrast.
  • Allergic to Tofacitinib or similar drugs.
  • Uncontrolled health issues like infections, heart problems, or psychiatric conditions.
  • Pregnant or breastfeeding women.
  • History of severe high blood pressure or related conditions.
  • Severe nausea, digestive issues, or inability to absorb the medication.
  • Another cancer within the last 3 years, except for certain skin cancers.
  • Currently using Bevacizumab.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.