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NCT00085293 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
12
Enrollment target

NCT00085293: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00085293 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00085293, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
12 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG Decitabine
  • RADIATION Fludeoxyglucose F 18
  • PROCEDURE Positron emission tomography
  • RADIATION Iodine I 131
  • BIOLOGICAL Recombinant thyrotropin alfa

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2004-05
Est. Completion 2014-05
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00085293 record still lists

NCT00085293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).

The record links to 0 conditions, and to 5 interventions - of which Decitabine is the first listed.

NCT00085293 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00085293 about?

NCT00085293 is a clinical study titled "Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131". 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 lo...

What is the current status of trial NCT00085293?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2004-05. Estimated completion is 2014-05.

What interventions are being tested in trial NCT00085293?

The interventions under investigation include: Decitabine (DRUG), Fludeoxyglucose F 18 (RADIATION), Positron emission tomography (PROCEDURE), Iodine I 131 (RADIATION), Recombinant thyrotropin alfa (BIOLOGICAL).

Who is sponsoring clinical trial NCT00085293?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00085293's enrollment target sits among peer trials

12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00085293, the US trial registry maintained by the National Library of Medicine. NCT00085293 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.