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

Completed · Phase 2

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT00085293

Run by

National Cancer Institute (NCI)

People needed

12

Starts

2004-05-01

Expected to finish

2014-05-01

Last updated by the study team

2018-11-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed papillary thyroid or follicular thyroid carcinoma:
• Differentiated disease;
• Metastatic disease documented by ultrasound, computed tomography (CT) scan (without iodinated contrast), or MRI - All metastatic disease foci =< 10 mm in all dimensions
• Must have been treated with total or near-total thyroidectomy AND at least 1 course of iodine I 131 (131I)(>=29.9 mCi) OR demonstrated negative uptake on a postoperative low-dose131I scan
• Must have undergone whole body 131I scan 1-3 days after administration of =< 5.5 mCi of 131I demonstrating no visible iodine uptake within the lesions unless demonstrated negative uptake on a postoperative low-dose131I scan within the past 12 weeks:
• Must have 24-hour urine iodine excretion =< 500 mcg within 1 week of 131I scan
• Must be receiving thyroid hormone therapy AND have thyroid-stimulating hormone level =< 0.5 mU/L
• No known brain metastases
• Performance status:
• Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100%
• Hematopoietic:
• Absolute neutrophil count >= 1,500/mm3;
• Platelet count >= 100,000/mm3;
• White Blood Count (WBC) >= 3,000/mm3
• Hepatic:
• aspartate aminotransferase-alanine aminotransferase (AST and ALT) =< 2.5 times upper limit of normal;
• Bilirubin normal
• Renal:
• Creatinine not elevated OR
• Creatinine clearance >= 60 mL/min
• Cardiovascular:
• No symptomatic congestive heart failure;
• No unstable angina pectoris;
• No cardiac arrhythmia
• Not pregnant or nursing

Where it is running

• University of Colorado at Denver — Aurora, Colorado, United States
• Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center — Columbus, Ohio, United States
• M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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