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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00085293 |
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 |
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Head and Neck Cancer |
Drug: decitabine Drug: iodine I 131 |
Phase II |
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 |
Estimated Enrollment: | 37 |
Study Start Date: | February 2005 |
Estimated Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed papillary thyroid or follicular thyroid carcinoma
Metastatic disease documented by ultrasound, CT scan (without iodinated contrast), or MRI
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
PATIENT CHARACTERISTICS:
Age
Performance status
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
Study Chair: | Steven I. Sherman, MD | M.D. Anderson Cancer Center |
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 |
recurrent thyroid cancer stage IV follicular thyroid cancer stage IV papillary thyroid cancer |
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 |
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 |