Selpercatinib to Enhance RAI Avidity in Children, Adolescents, and Young Adults With Newly Diagnosed Differentiated Thyroid Cancers Harboring RET Fusions
Children's Hospital of Philadelphia
Summary
Papillary thyroid cancer (PTC) is the most common form of differentiated thyroid cancer (DTC). The traditional first line treatment for patients with advanced DTC after surgical resection is radioactive iodine (RAI) therapy. However, less than a quarter of patients with lung metastases will achieve a complete response to RAI therapy, and this therapy carries the risk of pulmonary fibrosis and an increasingly recognized risk of secondary malignancies.
Description
This will be an open label, non-randomized study to evaluate the efficacy and safety of the combination of selpercatinib followed by 131I therapy for patients with RET fusion differentiated thyroid cancer. The primary Phase II objective will be to evaluate the pulmonary structural response rate at 18 months to the combination of selpercatinib given for 6-months followed by 131I therapy. This is exempt from Investigational New Drug requirements per the FDA.
Eligibility
- Age range
- 2–25 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age 2-25 years, inclusive 2. Histologic diagnosis of a differentiated thyroid cancer, status post thyroidectomy and adequate local therapy (e.g., lymph node dissection as per standard of care) for metastatic disease in the neck in the opinion of the treating investigator 3. Anatomically evaluable disease on chest CT (Computed Tomography) meeting one of the following criteria (obtained within 90 days of enrollment): A. multiple (\> 10) noncalcified solid pulmonary nodules visible on CT and/or B. enlarging, discrete pulmonary nodules visible on CT of any number consis…
Interventions
- DrugSelpercatinib Monotherapy
Patients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose.
- Radiation131I Therapy
Patients will receive 131I therapy after 6 months of selpercatinib.
Locations (4)
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- St. Jude Children's Research HospitalMemphis, Tennessee
- MD Anderson Cancer CenterHouston, Texas
- Seattle Children's HospitalSeattle, Washington