Phase II Study of Decitabine in Patients With Metastatic Papillary Thyroid Cancer or Follicular Thyroid Cancer Unresponsive to Radioiodine
Decitabine
+ Iodine I 131
+ Recombinant thyrotropin alfa
Thyroid Cancer, Papillary+11
+ Adenocarcinoma
+ Adenocarcinoma, Papillary
Treatment Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.PRIMARY OBJECTIVE: 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. SECONDARY OBJECTIVES: 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 intravenous (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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.12 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Histologically confirmed papillary thyroid or follicular thyroid carcinoma: * Differentiated disease; * Metastatic disease documented by ultrasound, computed tomography (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: * Eastern Cooperative Oncology Group (ECOG) 0-2 OR Karnofsky 60-100% * Hematopoietic: * Absolute neutrophil count \>= 1,500/mm3; * Platelet count \>= 100,000/mm3; * White Blood Count (WBC) \>= 3,000/mm3 * Hepatic: * aspartate aminotransferase-alanine aminotransferase (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)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, United StatesM D Anderson Cancer Center
Houston, United States