CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Decitabine +4 moredrug
Likely dose
Decitabine 6 mg/m² intravenously over 1 hour daily for 5 successive days every 2 weeks (10 doses), with possible second courseAI-extracted
Key inclusion· 7
  • Histologically confirmed papillary or follicular thyroid carcinoma, differentiated, with metastatic disease documented by imaging
  • All metastatic disease foci ≤10 mm in all dimensions
  • Prior total or near-total thyroidectomy AND at least 1 course of radioiodine (≥29.9 mCi) OR demonstrated negative uptake on postoperative low-dose scan
  • Whole body radioiodine scan within 1-3 days demonstrating no visible iodine uptake in lesions, OR negative uptake on postoperative low-dose scan within past 12 weeks
Key exclusion· 7
  • Known brain metastases
  • Prior cytotoxic chemotherapy for thyroid cancer
  • Concurrent combination antiretroviral therapy for HIV-positive patients
  • Other concurrent anticancer therapy or investigational agents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00085293
NCT00085293Phase 2Completed

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

National Cancer Institute (NCI)·interventional·Posted Jun 11, 2004·Updated Nov 29, 2018

In Brief

A Phase 2 clinical trial evaluating Decitabine, Iodine I 131, and 3 other interventions for Recurrent Thyroid Cancer and 6 related conditions. Completed, enrolled 12 participants across 3 sites.

Detailed 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.

Study Details

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 11, 2004
Enrollment StartMay 1, 2004
Primary CompletionJan 1, 2014
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.7 yearsPosted 22.1 years ago

Interventions

Decitabinedrug

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.

Iodine I 131radiation

Undergo thyrotropin-alfa stimulated radioactive iodine scan

Recombinant thyrotropin alfabiological

Undergo thyrotropin-alfa stimulated radioactive iodine scan

Fludeoxyglucose F 18radiation

Optional correlative studies

Positron emission tomographyprocedure

Optional correlative studies