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

Phase 2
18 Years
Open (Enrolling)
Recurrent Thyroid Cancer, Stage IVA Follicular Thyroid Cancer, Stage IVA Papillary Thyroid Cancer, Stage IVB Follicular Thyroid Cancer, Stage IVB Papillary Thyroid Cancer, Stage IVC Follicular Thyroid Cancer, Stage IVC Papillary Thyroid Cancer

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Trial Information

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


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.


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 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.

Inclusion Criteria:

- Histologically confirmed papillary thyroid or follicular thyroid carcinoma:

- Differentiated disease;

- Metastatic disease documented by ultrasound, 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:

- ECOG 0-2 OR Karnofsky 60-100%

- Hematopoietic:

- Absolute neutrophil count >= 1,500/mm3;

- Platelet count >= 100,000/mm3;

- WBC >= 3,000/mm3

- Hepatic:

- 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)

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Restoration of radioiodine uptake in metastatic lesions as demonstrated by diagnostic whole-body scanning after decitabine administration

Outcome Time Frame:

Week 3

Safety Issue:


Principal Investigator

Steven Sherman

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2004

Completion Date:

Related Keywords:

  • Recurrent Thyroid Cancer
  • Stage IVA Follicular Thyroid Cancer
  • Stage IVA Papillary Thyroid Cancer
  • Stage IVB Follicular Thyroid Cancer
  • Stage IVB Papillary Thyroid Cancer
  • Stage IVC Follicular Thyroid Cancer
  • Stage IVC Papillary Thyroid Cancer
  • Thyroid Neoplasms
  • Thyroid Diseases
  • Adenocarcinoma, Follicular



Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center Columbus, Ohio  43210-1240
M D Anderson Cancer Center Houston, Texas  77030
University of Colorado at Denver Health Sciences Center Denver, Colorado  80045