Azacitidine to Restore Thyroid Function in Patients With Persistent or Metastatic Thyroid Cancer

December 18, 2013 updated by: Lucille P. Markey Cancer Center at University of Kentucky

Restoration of Radioiodine Uptake in Thyroid Carcinoma: A Clinical Trial

RATIONALE: Azacitidine may help thyroid cancer cells regain the ability to take up iodine. This would allow the cancer to be detected and treated by radioactive iodine.

PURPOSE: Phase I trial to study the effectiveness of azacitidine to restore thyroid function in treating patients who have persistent or metastatic thyroid cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES: I. Determine the ability of azacitidine to restore iodine uptake by dedifferentiated thyroid cancer, enabling detection and treatment with iodine I 131 in patients with metastatic follicular or papillary thyroid cancer. II. Evaluate different doses and schedules of azacitidine administration to determine an optimally effective combination for restoration of iodine I 131 uptake with acceptable toxicity in this patient population. III. Determine the efficacy of azacitidine plus iodine I 131 in this patient population.

OUTLINE: This is a dose escalation study of azacitidine. Patients undergo a control phase consisting of oral liothyronine sodium twice daily on weeks 1-4 and a low iodine diet on weeks 4-7. At week 6, patients receive a scan dose of iodine I 131 followed by whole body scanning over 5 days. Beginning at week 7, patients undergo a treatment phase consisting of oral liothyronine sodium twice daily for 3 weeks, azacitidine subcutaneously daily for 10 or 20 days (weeks 7-11) and a low iodine diet on weeks 8-11. During week 11, patients undergo additional whole body scanning over 5 days followed by a therapeutic dose of iodine I 131. Patients achieving successful therapy receive 5 additional doses of azacitidine. Cohorts of 4 patients receive escalating doses of azacitidine until demonstrable radioiodine uptake is seen or the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 8 patients experience dose limiting toxicity. Patients are followed weekly for 8 weeks.

PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0084
        • Albert B. Chandler Medical Center, University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS: Radiologically confirmed persistent or metastatic follicular or papillary thyroid cancer following total thyroidectomy and radioiodine ablation therapy Metastatic disease confirmed histologically or cytologically or by elevated thyroglobulin levels No radioiodine uptake by whole body scanning Stable iodine contamination from radiologic contrast material within the past 10 months allowed, if absence of current contamination demonstrated by less than 80 micrograms of iodine in a 24 hour urine collection

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: At least 4 weeks since prior levothyroxine Any prior therapy for restoration of radioiodine uptake allowed, if unsuccessful and did not exceed treatment schedules planned for this study

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lucille P. Markey Cancer Center at University of Kentucky

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Kenneth Ain, MD, Lucille P. Markey Cancer Center at University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1999

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

December 10, 1999

First Submitted That Met QC Criteria

June 3, 2004

First Posted (Estimate)

June 4, 2004

Study Record Updates

Last Update Posted (Estimate)

December 19, 2013

Last Update Submitted That Met QC Criteria

December 18, 2013

Last Verified

May 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067262
  • UKMC-9700053
  • NCI-T99-0045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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