Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine
I. Determine whether decitabine can restore iodine I 131 (131I) uptake in patients with
metastatic papillary thyroid or follicular thyroid cancer lesions that are undetectable by
low-dose iodine 131I scanning.
I. Determine the efficacy of 131I therapy, administered after restoration of 131I uptake by
decitabine, in these patients.
II. Determine the effect of decitabine on clinical and molecular markers of thyroid cancer
cell differentiation in these patients.
III. Determine the safety and tolerability of decitabine in patients undergoing thyroid
hormone withdrawal-induced hypothyroidism and 131I therapy.
OUTLINE: This is an open-label, multicenter study.
Patients receive decitabine IV over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1).
On week 3, patients undergo iodine I 131 (131I) scanning using thyrotropin alfa injections.
Patients whose scan does not demonstrate iodine uptake continue suppressive thyroid hormone
therapy but receive no further study therapy. These patients undergo study follow up.
Patients whose scan demonstrates iodine uptake undergo thyroid hormone withdrawal on weeks
4-8 and receive a second course of decitabine (as in course 1) on weeks 7 and 8. Patients
then receive 131I therapy on week 9.
Patients are followed at 3 and 6 months.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Restoration of radioiodine uptake in metastatic lesions as demonstrated by diagnostic whole-body scanning after decitabine administration
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Columbus, Ohio 43210-1240|
|M D Anderson Cancer Center||Houston, Texas 77030|
|University of Colorado at Denver Health Sciences Center||Denver, Colorado 80045|