Phase 2 N=12 Treatment

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

Recurrent Thyroid Cancer · Stage IVA Follicular Thyroid Cancer · Stage IVA Papillary Thyroid Cancer · Stage IVB Follicular Thyroid Cancer · Stage IVB Papillary Thyroid Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00085293 ↗

Enrolled (actual)

Serious AEs

75.0%

Results posted

Sep 2014

Primary outcome: Primary: Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration — 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Decitabine (Drug); Iodine I 131 (Radiation); Recombinant thyrotropin alfa (Biological); Fludeoxyglucose F 18 (Radiation); Positron emission tomography (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Cancer Institute (NCI)
Primary completion: Jan 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration	—	—
SECONDARY Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0	42; 33; 25; 25; 25; 25	—
SECONDARY Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease.	—	—
SECONDARY Change in Fludeoxyglucose (FDG) Uptake Measured by Positron Emission Tomography in Metastatic Tumor Sites Before and After DNA-methyltransferase Inhibitor Therapy (Optional). No Secondary Endpoints Were Measured as no Patient Met the Primary Endpoint.	—	—
SECONDARY Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease	—	—
SECONDARY Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level	—	—
SECONDARY Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level.These Secondary Endpoints Would Only Have Been Assessed if a Patient Had Met the Primary Endpoint, Restoration of Radioiodine Uptake to Justify Radioiodine Therapy.	—	—

Summary

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. 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.

Eligibility 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 = =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 = = 1,500/mm3;
Platelet count >= 100,000/mm3;
White Blood Count (WBC) >= 3,000/mm3
Hepatic:
aspartate aminotransferase-alanine aminotransferase (AST and ALT) = = 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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00085293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.