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Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Studying dabrafenib and trametinib post-radiation for high-grade glioma patients.

Recruiting
3-25 years
All
Phase 2

Dabrafenib and Trametinib for High-Grade Glioma Study

This study looks at how well two drugs, dabrafenib and trametinib, work together after radiation therapy for treating high-grade glioma. Glioma is a type of brain tumor. These drugs aim to stop cancer cells from growing by blocking certain proteins they need. The study is for children and young adults with a specific genetic change called the BRAF V600 mutation.

Participants will first undergo radiation therapy, which uses rays to shrink tumors. After radiation, they will take dabrafenib twice daily and trametinib once daily every 28 days, for up to 24 cycles. Throughout the study, patients will have regular MRI scans to monitor tumor changes.

  • Study length: Up to 24 cycles (approximately 2 years) with regular follow-ups for up to 5 years.
  • Participants: Must be 3-25 years old, with specific genetic mutations and no prior treatment.
  • Risks: Potential side effects from drugs and radiation therapy; regular MRI scans required.

Eligibility includes having a confirmed diagnosis without previous treatment and meeting health requirements. Participants will need to agree to tests and follow-ups during and after the study.

Study details
    Anaplastic Astrocytoma
    Anaplastic Astrocytoma
    Not Otherwise Specified
    Anaplastic Ganglioglioma
    Anaplastic Pleomorphic Xanthoastrocytoma
    Glioblastoma
    Malignant Glioma
    WHO Grade 3 Glioma

NCT03919071

National Cancer Institute (NCI)

12 January 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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