Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	18 and over	NCI	MDA-2003-0308 5954, NCI-5954, NCT00085293

Objectives

Primary

1. 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

1. Determine the efficacy of ¹³¹I therapy, administered after restoration of ¹³¹I uptake by decitabine, in these patients.
2. Determine the effect of decitabine on clinical and molecular markers of thyroid cancer cell differentiation in these patients.
3. Determine the safety and tolerability of decitabine in patients undergoing thyroid hormone withdrawal-induced hypothyroidism and ¹³¹I therapy.

Entry Criteria

Disease Characteristics:

• 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

   [Note: *Scanning must have been performed after a two-dose regimen of thyrotropin alfa]




• Must be receiving thyroid hormone therapy AND have thyroid-stimulating hormone level ≤ 0.5 mU/L



• No known brain metastases

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic chemotherapy for thyroid cancer

Endocrine therapy

• See Disease Characteristics

Radiotherapy

• See Disease Characteristics
• 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

  OR

• More than 18 months since prior cumulative ¹³¹I activity of at least 500 mCi
• More than 3 months since prior IV or oral iodinated contrast for radiographic studies*
• More than 6 months since prior intrathecal iodinated contrast*

 [Note: *Unless 24-hour urinary iodine excretion is ≤ 500 mcg]

Surgery

• See Disease Characteristics

Other

• More than 12 months since prior amiodarone*
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent anticancer therapy
• No other concurrent investigational agents

 [Note: *Unless 24-hour urinary iodine excretion is ≤ 500 mcg]

Patient Characteristics:

Age

• 18 and over

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

Other

• 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

Expected Enrollment

A total of 12-37 patients will be accrued for this study within 4-18.5 months.

Outcomes

Restoration of radioiodine uptake in metastatic lesions at the first week following completion of course 1

Efficacy of radioiodine therapy following restoration of uptake by decitabine by radiologic studies at 3 and 6 months following radioiodine 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 months.

Trial Contact Information

Trial Lead Organizations

M. D. Anderson Cancer Center at University of Texas

Steven Sherman, MD, Protocol chair		Ph: 713-792-2841; 800-392-1611 Email: sisherma@mdanderson.org

Registry Information
Official Title		Phase II Study Of Decitabine In Patients With Metastatic Papillary Thyroid Cancer Or Follicular Thyroid Cancer Unresponsive To Radioiodine
Trial Start Date		2005-02-10
Trial Completion Date		2010-06-19 (estimated)
Registered in ClinicalTrials.gov		NCT00085293
Date Submitted to PDQ		2004-04-27
Information Last Verified		2009-06-21
NCI Grant/Contract Number		CA16672, CM17003

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