Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer (NCT03975231) | Clinical Trial Compass
RecruitingPhase 1
Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer
United States6 participantsStarted 2020-09-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 (ECOG) performance status \< 2.
* Absolute neutrophil count \> 1,000/mcL.
* Hemoglobin \>= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 9.0 g/dl is acceptable).
* Platelets \> 75,000/mcL.
* Total bilirubin \< 1.5 x institutional upper limit of normal (unless due to Gilbert?s disease).
* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) \< 2.5 x institutional upper limit of normal.
* Serum creatinine \< 1.5 x institutional upper limit of normal.
* Female patients of childbearing potential are required to have a negative serum pregnancy test within 14 days prior to the first dose of study medication.
* Females are required to use an effective method of contraception from the time of negative serum pregnancy test, throughout the st…
What they're measuring
1
Maximum tolerated dose of combination therapy of dabrafenib and trametinib administered concurrently with intensity-modulated radiation therapy (IMRT)