| Inclusion Criteria: | 1) Histologically confirmed differentiated thyroid carcinoma (papillary or follicular type).
2) Previously been treated with total or near-total thyroidectomy. Must have been treated with at least one course of 131I, or demonstrated negative uptake on a low-dose 131I scan post-operatively. External beam radiotherapy may have previously been administered for locoregional disease in the thyroid bed, or cervical or upper mediastinal lymph node regions, but must have been completed at least 6 months prior to entry.
3) Metastatic disease radiographically documented but must measure 10 mm or less.
4) Within 12 weeks of entry, must have undergone a whole body radioiodine scan one to three days following administration 131I that demonstrates no visible uptake in the metastatic lesions, unless demonstrated negative uptake on a low-dose 131I scan post-operatively. Patients should have undergone the scan following administration of a two dose regimen of thyrotropin alfa. Within one week of the negative radioiodine scan, patients must have had a 24 hr urine iodine excretion demonstrated to be no more than 500 mcg, thereby avoiding a possible false-negative scan due to iodine excess.
5) Must be receiving thyroid hormone therapy with a documented serum TSH level less than or equal to 0.5 mU/L within 4 weeks of study entry, without an intervening change in the prescribed dosage of thyroid hormone therapy
6) Age at least 18 years.
7) ECOG performance status less than or equal to 2 (Karnofsky at least 60%).
8) Patients must have normal organ and marrow function as defined below demonstrated within 4 weeks of study entry: Leukocytes at least 3,000/microliter ANC at least 1,500/microliter platelets at least 100,000/microliter, total bilirubin not more than institutional upper limit of normal, AST(SGOT)/ALT(SGPT) not more than 2.5 X institutional upper limit of normal, creatinine not more than institutional upper limit of normal OR creatinine clearance at least 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
9) The effects of decitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because DNA hypomethylating agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
10) Ability to understand and the willingness to sign a written informed consent document. |