Phase 1 Study of Dabrafenib, Trametinib, and Intensity Modulated Radiation Therapy in Treating Adults with BRAF Mutated Anaplastic Thyroid Cancer

What this Trial Is About

Researchers are evaluating how well a combination of dabrafenib, trametinib, and intensity modulated radiation therapy IMRT works in treating patients with BRAF mutated anaplastic thyroid cancer. This study aims to assess the safety, tolerability, and effectiveness of combining these treatments to potentially kill more tumor cells. It is a phase 1 trial focusing on patients with aggressive thyroid cancer that has specific BRAF mutations. Patients first receive oral dabrafenib twice daily and trametinib once daily for 7 to 28 days if their disease does not progress and they tolerate the drugs. Those with tumors that can be surgically removed may have surgery followed by radiation therapy combined with dabrafenib and trametinib. Radiation is delivered Monday through Friday over 6.5 weeks during concurrent drug treatment. After radiation, patients continue the oral drugs for four weeks and then may have ongoing maintenance treatment depending on residual disease status. Throughout the study, participants undergo various assessments including monitoring for side effects, tumor response, and survival outcomes. Researchers track blood levels of the drugs and study mechanisms of resistance. After study treatment ends, patients are followed every two months for one year to monitor their health. The main goal is to identify the highest safe dose of the combined therapy while evaluating its effects on disease progression and survival.

Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer