A Phase I Trial of Concurrent Intensity Modulated Radiation Therapy (IMRT) and Dabrafenib/Trametinib in BRAF Mutated Anaplastic Thyroid Cancer
City of Hope Medical Center
Summary
This trial studies how well dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) work together in treating patients with BRAF mutated anaplastic thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving dabrafenib, trametinib, and IMRT together may kill more tumor cells.
Description
PRIMARY OBJECTIVES: I. To assess the safety and tolerability (maximum tolerated dose \[MTD\]) of concurrent intensity modulated radiation therapy (IMRT) and BRAF-MEK inhibitors dabrafenib and trametinib in patients with BRAF-mutated anaplastic thyroid cancer. SECONDARY OBJECTIVES: I. To assess overall objective response rate, time to progression of local recurrence, progression free survival and overall survival. II. To assess pharmacokinetics during concurrent IMRT and dabrafenib plus trametinib therapy. III. To assess pharmacodynamics of dabrafenib plus trametinib induction therapy. IV…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Pathologic (histologic or cytologic) diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be ?consistent with anaplastic thyroid cancer? with the presence of a thyroid mass is acceptable; pathology showing additional types of thyroid cancer is allowed) * Note: Tissue collection for central review is mandatory, but central review is not required for eligibility. Due to the aggressiveness of this disease, treatment will be started prior to central review. * Presence of BRAF mutation (V600E or V600K) in tumor tissue. * Eastern Cooperative Oncology Group (…
Interventions
- DrugDabrafenib
Given PO
- RadiationIntensity-Modulated Radiation Therapy
Undergo IMRT
- DrugTrametinib
Given PO
Locations (3)
- City of Hope Medical CenterDuarte, California
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- Univ of Texas-M.D. Anderson Cancer CenterHouston, Texas