A Phase II Study of Radioactive Iodine with and without Selumetinib in Patients with High-Risk Thyroid Cancer After Thyroidectomy

Protocol
13-133
Full Title
A Randomized, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients with Differentiated Thyroid Cancer
Phase
III
Purpose

The standard therapy for thyroid cancer is surgery followed by radioactive iodine. The radioactive iodine is given in part to kill thyroid cancer cells remaining in the body after surgery. However, for some patients with higher-risk thyroid cancer, radioactive iodine alone does not completely eliminate all residual thyroid cancer cells or prevent thyroid cancer from coming back after surgery.

The goal of this study is to see if the investigational drug selumetinib (which inhibits a protein commonly involved in cancer called MEK) can improve how well radioactive iodine works against thyroid cancer and increase the chance of achieving a complete remission. Patients will be randomly assigned to receive a single dose of radioactive iodine after surgery with either selumetinib or a placebo. Selumetinib is taken orally (by mouth).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have thyroid cancer that has been surgically removed and has specific high-risk pathologic features.
  • Patients should be candidates for radioactive iodine therapy.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Alan L. Ho at 646-888-4235.

Disease(s)
Thyroid Cancer
Locations
Related Diseases