Actively Recruiting
Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer
Led by City of Hope Medical Center · Updated on 2026-04-08
6
Participants Needed
3
Research Sites
368 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of anaplastic thyroid cancer confirmed by pathology
- Presence of BRAF mutation (V600E or V600K) in tumor tissue
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- Absolute neutrophil count greater than 1,000/mcL
- Hemoglobin level at least 9.0 g/dl (transfusions allowed to reach this level)
- Platelet count greater than 75,000/mcL
- Total bilirubin less than 1.5 times the institutional upper limit of normal (unless due to Gilbert's disease)
- AST and ALT less than 2.5 times the institutional upper limit of normal
- Serum creatinine less than 1.5 times the institutional upper limit of normal
- Female patients of childbearing potential must have a negative pregnancy test within 14 days before starting treatment
- Use of effective contraception for females during and for 4 months after study treatment
- Male patients must use contraception during and for 16 weeks after treatment
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Patients with resectable stage IVA anaplastic thyroid cancer who plan surgery
- Prior external beam radiotherapy to neck or chest overlapping study radiation fields
- Cytotoxic chemotherapy, stereotactic brain radiation, or external beam radiation within 2 weeks before study treatment
- Oral multikinase inhibitors within 1 week before study treatment
- Not recovered from prior cancer therapy side effects worse than grade 2 except hair loss
- Previous treatment with potent BRAF or MEK inhibitors (except sorafenib)
- Receiving other investigational agents
- Taking prohibited medications
- History of other active cancers needing treatment
- Uncontrolled brain metastases or using enzyme-inducing anti-epileptic drugs
- Known retinal vein occlusion, central serous retinopathy, uncontrolled glaucoma, or ocular hypertension
- Class II, III, or IV heart failure
- Corrected QT interval 480 msecs or greater (500 msecs for bundle branch block)
- Uncontrolled illnesses like infection requiring IV antibiotics, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting participation
- Pregnant or nursing women
- Known HIV-positive or on antiretroviral therapy due to drug interaction risks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
2
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
3
Univ of Texas-M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sasan Fazeli, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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