NCT00085293

Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131

Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine. Iodine I 131 (radioactive iodine) kills thyroid cancer cells. Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine. Decitabine may help thyroid cancer cells regain the ability to respond to treatment with radioactive iodine.

Detailed description

PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVES: 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 intravenous (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.

Conditions

• Recurrent Thyroid Cancer
• Stage IVA Follicular Thyroid Cancer
• Stage IVA Papillary Thyroid Cancer
• Stage IVB Follicular Thyroid Cancer
• Stage IVB Papillary Thyroid Cancer
• Stage IVC Follicular Thyroid Cancer
• Stage IVC Papillary Thyroid Cancer

Interventions

Type	Name	Description
DRUG	Decitabine	Starting dose 6 mg/m\^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.
RADIATION	Iodine I 131	Undergo thyrotropin-alfa stimulated radioactive iodine scan
BIOLOGICAL	Recombinant thyrotropin alfa	Undergo thyrotropin-alfa stimulated radioactive iodine scan
RADIATION	Fludeoxyglucose F 18	Optional correlative studies
PROCEDURE	Positron emission tomography	Optional correlative studies

Timeline

• Start date: 2004-05-01
• Primary completion: 2014-01-01
• Completion: 2014-05-01
• First posted: 2004-06-11
• Last updated: 2018-11-29
• Results posted: 2014-09-01

Locations

3 sites across 1 country: United States