Completed

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

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What is being tested

Decitabine

+ Iodine I 131

+ Recombinant thyrotropin alfa

DrugRadiationBiologicalProcedure
Who is being recruted

Thyroid Cancer, Papillary+11

+ Adenocarcinoma

+ Adenocarcinoma, Papillary

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: May 2004
See protocol details

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitlePhase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine 
NCT00085293
Principal SponsorNational Cancer Institute (NCI)
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

12 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Thyroid Cancer, PapillaryAdenocarcinomaAdenocarcinoma, PapillaryCarcinomaEndocrine System DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialThyroid DiseasesThyroid NeoplasmsAdenocarcinoma, Follicular

Criteria

Inclusion Criteria: * 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 * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reaction attributed to compounds of similar chemical or biological composition to decitabine * No concurrent uncontrolled illness * No active or ongoing infection * No psychiatric illness or social situation that would preclude study compliance * No prior cytotoxic chemotherapy for thyroid cancer * At least 6 months since prior external beam radiotherapy administered for locoregional disease in the thyroid bed or to the cervical or upper mediastinal lymph node regions (no more than 6,000 cGy) * More than 6 months since other prior radiotherapy and recovered * More than 6 months since prior therapeutic 131I \> 10 mCi * More than 18 months since prior cumulative 131I activity of at least 500 mCi * More than 12 months since prior amiodarone (Unless 24-hour urinary iodine excretion is =\< 500 mcg) * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent anticancer therapy * No other concurrent investigational agents * More than 6 months since prior intrathecal iodinated contrast (Unless 24-hour urinary iodine excretion is =\< 500 mcg) * More than 3 months since prior IV or oral iodinated contrast for radiographic studies (Unless 24-hour urinary iodine excretion is =\< 500 mcg)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Starting dose 6 mg/m\^2 Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

University of Colorado at Denver

Aurora, United StatesSee the location
Suspended

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, United States
Suspended

M D Anderson Cancer Center

Houston, United States
Completed3 Study Centers