Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT02145143|
Recruitment Status : Active, not recruiting
First Posted : May 22, 2014
Last Update Posted : February 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Carcinoma||Drug: Vemurafenib Device: serial 124I PET/CT Drug: thyrotropin alpha||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study|
|Actual Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: thyroid cancer patients
Patients will have lesional dosimetry with 124I PET/CT performed to quantify the baseline iodine avidity of index metastatic lesion(s). Patients will then receive vemurafenib (960 mg orally BID) for about 4 weeks, after which a second 124I PET/CT will be performed. For patients in whom the second 124I PET/CT demonstrates that > or = 2000 cGy can be achieved in at least one tumor with < 300 mCi of 131I, Thyrogen-stimulated standard dosimetry & therapeutic 131I will be performed/administered concurrently with vemurafenib. The drug will then be discontinued & tumor assessments will be conducted with serial radiologic scan(s) & thyroglobulins (scans will be performed at baseline, before 131I, 3-4 months following 131I, & 6 months after 131I). Patients whose tumors fail to demonstrate adequate iodine incorporation following vemurafenib to warrant 131I therapy, the study drug will be discontinued, a final tumor assessment will be performed, & the patient will be taken off the study.
Device: serial 124I PET/CT
Drug: thyrotropin alpha
- Response [ Time Frame: 1 year ]The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that progressive disease is objectively documented.
- objective response rate (ORR) [ Time Frame: 6 months ]To evaluate the effect of vemurafenib on enhancing 131I activity by determining the ORR by RECIST v1.1 criteria at 6 months following treatment with vemurafenib +/- 131I.
- safety [ Time Frame: 1 year ]Toxicities will be assessed through the NCI-Common Terminology Criteria for Adverse Events version 4.0, individually reported and summarized. Monitoring for vemurafenib-related toxicities will be continued until 30 days after the last dose of drug therapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02145143
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Alan L. Ho, MD, PhD||Memorial Sloan Kettering Cancer Center|