Clinical Trial in RAI-Refractory Thyroid Carcinoma Evaluating BRAF & MEK Blockade for Re-differentiation Therapy
Status:
Recruiting
Trial end date:
2022-04-01
Target enrollment:
Participant gender:
Summary
Progressive and metastatic thyroid cancer patients, who no longer respond to radioactive
iodine (RAI), are currently treated with long term tyrosine kinase inhibitors to control
tumor growth. The investigators will study the effect of short term oral anti-cancer drug
combination, called dabrafenib (BRAF inhibitor) and trametinib (MEK inhibitor), in improving
thyroid cancer RAI absorption that can potentially lead to tumor shrinkage response. To
assess for suitability, participant's thyroid cancer tissue taken at the time of surgery will
be tested for DNA changes, such as BRAFV600E, RAS, or MEK mutations.
Based on experimental studies, the response to these medications could occur within 1 week of
treatment. So in the study, the investigators will find out whether participant's cancer
would respond to 1 week of treatment with these medications rather than the 1 month duration
of treatment in previous re-differentiation clinical trials. After 1 week of treatment with
dabrafenib and trametinib, iodine absorption I-124 PET-CT scan will predict if the cancer
will respond to RAI. If iodine absorption is insufficient on the scan, treatment with
dabrafenib and trametinib will be continued for a total of 4 weeks. Then iodine absorption
response of participant's cancer will be assessed on I-124 PET-CT scan again. If the iodine
absorption is good at 1 week or 4 weeks, the investigators will treat the participant with
thyroid cancer using RAI.
The 1-week treatment regime can potentially save cost, avoid drug toxicity with prolonged
treatment, and prevent drug resistance that can occur with longer treatment period.