Study on Pre-Radiation Chemotherapy for Newly Diagnosed High-Grade Glioma

Sponsor: The Cooper Health System

Sponsor score: 0

ClinicalTrials ID:NCT07439172

Provider View

This clinical trial is exploring whether giving chemotherapy before radiation can improve treatment for patients with high-grade gliomas, a type of brain tumor. The study will use the drug temozolomide, which is already approved for treating these tumors, to see if this approach makes MRI scans easier to interpret and helps in testing new drugs in the future.

Patient Parameters

Program Overview

This study aims to find better ways to treat high-grade gliomas, a type of aggressive brain tumor. Researchers are testing if administering chemotherapy before radiation therapy can be effective. Typically, radiation can make MRI scans of the brain harder to read, but giving chemotherapy first might make these scans clearer. The study will start by using temozolomide, a chemotherapy drug already approved for treating gliomas, to see if this method works. If successful, this approach could be used to test new drugs in the future.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-grade glioma.
  • Have a measurable tumor remaining after surgery.
  • No immediate need for radiation or chemotherapy due to severe symptoms.
  • Able to understand and agree to the study requirements.
  • Willing to follow all study procedures and be available for the study duration.
  • Aged between 18 and 80 years.
  • Have a Karnofsky Performance Status of 70% or higher, indicating good general health.
  • Have adequate organ and bone marrow function, as shown by specific blood test results.
  • Able to take oral medication and willing to follow the pre-radiation temozolomide treatment plan.
  • Women of childbearing potential must use effective birth control starting at least one week before the study and continue during the study and for four weeks after.
  • Men must use condoms or other effective birth control methods with their partners.
  • Must have measurable disease according to specific medical criteria.

Exclusion Criteria

  • Currently taking other experimental drugs.
  • Had Gliadel wafer or similar local treatment placed in the tumor area during surgery.
  • Have a history of allergic reactions to temozolomide or similar drugs.
  • Have uncontrolled illnesses, such as ongoing infections or psychiatric conditions, that would interfere with the study.
  • Pregnant women cannot participate due to potential risks to the unborn baby. Breastfeeding should be stopped if the mother is treated with temozolomide.

Locations

FACILITYZIPCITYSTATE
Cooper University HealthCare08103CamdenNew Jersey

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