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Restoration of Radioiodine Uptake in Thyroid Carcinoma: A Clinical Trial

Phase 1
Not Enrolling
Head and Neck Cancer

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Trial Information

Restoration of Radioiodine Uptake in Thyroid Carcinoma: A Clinical Trial

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

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.

Inclusion Criteria

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Kenneth Ain, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lucille P. Markey Cancer Center at University of Kentucky


United States: Federal Government

Study ID:




Start Date:

July 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage IV papillary thyroid cancer
  • stage IV follicular thyroid cancer
  • recurrent thyroid cancer
  • Thyroid Neoplasms
  • Head and Neck Neoplasms
  • Thyroid Diseases



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