SEL-I-METRY
Research type
Research Study
Full title
Investigating the potential clinical benefit of Selumetinib in resensitising advanced iodine refractory differentiated thyroid cancer to radioiodine therapy.
IRAS ID
183600
Contact name
Jonathan Wadsley
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Eudract number
2015-002269-47
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Summary of Research
Thyroid cancer is the most common endocrine cancer, and while radioactive iodine therapy is an effective treatment for many patients, some patients will develop a thyroid cancer that does not take up iodine (iodine-refractory disease). This condition carries a much poorer prognosis with few 10 year survivors.
While some multi-target tyrosine kinase inhibitors have proved effective in reducing the rate of progression in such iodine-refractory tumours, these drugs must be taken continuously to provide benefit, and these treatment regimens have significant and unpleasant side effect.
Selumetinib, a MEK inhibitor, has been shown in a previous pilot study to be able to induce iodine uptake in previously iodine refractory thyroid cancers following a short, 4 week, course of treatment
This study is designed to determine the proportion of patients in which treatment with Selumetinib increases the amount of iodine taken up by the previously iodine-refractory thyroid cancers following a short course (4 weeks) of the drug. If significant increase in iodine uptake is seen, patients will receive further radioactive iodine therapy. Patients will then be followed up to determine whether this strategy impacts progression-free survival.
Summary of Results
Differentiated thyroid cancer (DTC) is a rare cancer that affects the thyroid gland at the base of the neck. Patients with advanced DTC can be treated with a radioactive form of iodine called iodine-131. The iodine-131 circulates in the body and is taken up by thyroid cancer cells, which the radiation then kills. Thyroid cancer can sometimes stop taking up radioactive iodine and this makes it harder to treat the cancer.
A previous trial showed that a targeted anti-cancer drug, Selumetinib, might make thyroid cancer cells sensitive to treatment with radioactive iodine therapy again. For patients with thyroid cancer that had stopped taking up radioactive iodine, the SEL-I-METRY trial aimed to find out if Selumetinib followed by further iodine-131 could increase the number of patients whose cancer did not progress (get worse) within one year. It also aimed to learn more about the side effects of Selumetinib and to find out more about patient’s quality of life.
The trial was stopped early due to slow recruitment and a lower than expected number of patients achieving increased iodine uptake after Selumetinib. 30 patients from eight NHS hospitals were enrolled. We originally planned to recruit 60 patients into the SEL-I-METRY trial. Patients who took part in the trial were given 75mg of Selumetinib tablets to take twice daily for 28 days. Radioactive iodine scans were taken before and after patients received Selumetinib, to see if the amount of radioactive iodine being taken up by the thyroid cancer cells had increased. Patients whose thyroid cancer started to take up radioactive iodine again were given iodine-131 to treat their cancer.
Fewer DTC patients than expected showed increased uptake of radioactive iodine in their cancer cells after receiving Selumetinib. Also, more patients had more side effects than previously reported with Selumetinib. Despite this, patients did not report a substantial change in their quality of life following Selumetinib treatment. However, for those patients who were able to have iodine-131, the number of patients whose cancer did not progress within one year did appear to have increased compared to what is expected from historical data from similar patients. Since the trial recruited fewer patients than planned it is not possible to draw definitive conclusions and further research is needed to confirm these findings.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
15/EM/0455
Date of REC Opinion
2 Dec 2015
REC opinion
Further Information Favourable Opinion