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Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine
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.
Details
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 12 |
| Start date | 2004-05 |
| Completion | 2014-05 |
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
- Decitabine
- Iodine I 131
- Recombinant thyrotropin alfa
- Fludeoxyglucose F 18
- Positron emission tomography
Primary outcomes
- Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration — Week 3 following 2 weeks of Decitabine therapy
Number of participants with restoration of radioiodine responsiveness as determined by visible uptake on radioiodine scan in radiographically detectable metastatic foci of papillary or follicular thyroid carcinoma. Response to Decitabine defined as demonstration of radioiodine uptake determined by centralized blinded review of diagnostic scan. All who demonstrated radioiodine uptake in metastatic foci following decitabine therapy would then undergo thyroid hormone withdrawal and a second course of decitabine in preparation for therapeutic administration of radioiodine. Diagnostic radioiodine scans following decitabine therapy (week 3) with a radioiodine scan following thyrotropin alfa stimulation, 0.9 mg intramuscular (IM) injection 24 and 48 hours before administration of the 131I for imaging. Whole body scans (WBS) performed using a gamma camera.
Countries
United States