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Decitabine in Treating Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Iodine I 131
This study has been suspended.
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00085293
  Purpose

RATIONALE: Iodine I 131 (radioactive iodine) kills thyroid cancer cells. Metastatic thyroid cancer cells can lose the ability to be treated with radioactive iodine. Decitabine may help thyroid cancer cells regain the ability to respond to treatment with radioactive iodine.

PURPOSE: This phase II trial is studying how well decitabine works in treating patients with metastatic papillary thyroid cancer or follicular thyroid cancer that has stopped responding to radioactive iodine.


Condition Intervention Phase
Head and Neck Cancer
Drug: decitabine
Drug: iodine I 131
Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer Thyroid Cancer
Drug Information available for: Iodine Cadexomer iodine Sodium iodide I 131 5-Aza-2'-deoxycytidine Thyroid
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study Of Decitabine In Patients With Metastatic Papillary Thyroid Cancer Or Follicular Thyroid Cancer Unresponsive To Radioiodine

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Restoration of radioiodine uptake in metastatic lesions at the first week following completion of course 1 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of radioiodine therapy following restoration of uptake by decitabine by radiologic studies at 3 and 6 months following radioiodine therapy [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: February 2005
Estimated Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • 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

  • Determine the efficacy of ^131I therapy, administered after restoration of ^131I uptake by decitabine, in these patients.
  • Determine the effect of decitabine on clinical and molecular markers of thyroid cancer cell differentiation in these patients.
  • 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 months.

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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-dose^131I 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-dose^131I 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • WBC ≥ 3,000/mm^3

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00085293

Locations
United States, Colorado
University of Colorado Cancer Center at UC Health Sciences Center
Aurora, Colorado, United States, 80045
United States, Maine
Maine Center for Cancer Medicine and Blood Disorders - Scarborough
Scarborough, Maine, United States, 04074
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1240
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States, 45267-0528
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Steven I. Sherman, MD M.D. Anderson Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000368467, MDA-2003-0308, NCI-5954
Study First Received: June 10, 2004
Last Updated: December 27, 2008
ClinicalTrials.gov Identifier: NCT00085293  
Health Authority: United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
recurrent thyroid cancer
stage IV follicular thyroid cancer
stage IV papillary thyroid cancer

Study placed in the following topic categories:
Adenocarcinoma, Follicular
Thyroid Neoplasms
Endocrine System Diseases
Decitabine
Recurrence
Carcinoma
Thyroid cancer, papillary
Head and Neck Neoplasms
Iodine
Endocrinopathy
Adenocarcinoma
Thyroid Diseases
Thyroid cancer, follicular
Endocrine Gland Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors
Trace Elements
Pharmacologic Actions
Anti-Infective Agents, Local
Neoplasms
Neoplasms by Site
Therapeutic Uses
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009