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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Patients will receive selpercatinib monotherapy for 6 months at the FDA-approved dose.
Patients will receive 131I therapy after 6 months of selpercatinib.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGSt. Jude Children's Research Hospital
Memphis, Tennessee, United States
RECRUITINGNumber of patients with complete overall, pulmonary, structural, and biochemical response.
Determine the overall, pulmonary, structural, and biochemical response rate to selpercatinib in patients with RET fusion differentiated thyroid cancer treated with 6 months of selpercatinib prior to 131I therapy
Time frame: 18 months
Number of patients who survive without progression of disease after 5 years following protocol treatment.
Determine the progression free survival to the combination of selpercatinib followed 6 months later 131I therapy from the initiation of selpercatinib therapy
Time frame: 5 years
Proportion of all patients enrolled who show increased radioactive iodine avidity at 6 months following selpercatinib monotherapy.
Determine the proportion of patients for whom oncogene-specific, targeted therapy increases tumor RAI-avidity.
Time frame: 6 months
The incidence of adverse events and dose limiting toxicity with the combination of selpercatinib and 131I therapy, graded according to CTCAE v5.
Determine the safety of the combination of selpercatinib given for 6-months followed by 131I therapy in patients with RET fusion differentiated thyroid cancer
Time frame: 12 months
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