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

NCT00085293 | Completed Phase 2 Results

• 6 other identifiers: NCI-2009-00033CDR000036846759542003-0308P30CA016672N01CM62207
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Recurrent Thyroid Cancer; Stage IVA Follicular Thyroid Cancer; Stage IVA Papillary Thyroid Cancer; Stage IVB Follicular Thyroid Cancer; Stage IVB Papillary Thyroid Cancer; Stage IVC Follicular Thyroid Cancer; Stage IVC Papillary Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• Restoration of Radioiodine Uptake in Metastatic Lesions as Demonstrated by Diagnostic Whole-body Scanning After Decitabine Administration

  Number of participants with restoration of radioiodine responsiveness as determined by visible uptake on radioiodine scan in radiographically detectable metastatic foci of papillary or follicular thyroid carcinoma. Response to Decitabine defined as demonstration of radioiodine uptake determined by centralized blinded review of diagnostic scan. All who demonstrated radioiodine uptake in metastatic foci following decitabine therapy would then undergo thyroid hormone withdrawal and a second course of decitabine in preparation for therapeutic administration of radioiodine. Diagnostic radioiodine scans following decitabine therapy (week 3) with a radioiodine scan following thyrotropin alfa stimulation, 0.9 mg intramuscular (IM) injection 24 and 48 hours before administration of the 131I for imaging. Whole body scans (WBS) performed using a gamma camera.

  Week 3 following 2 weeks of Decitabine therapy

Secondary Outcomes (6)

• Frequency of Adverse Events According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0

  Up to 6 months

• Efficacy of Subsequent Radioiodine Therapy in Terms of CR/PR/SD of Any Radiographic Disease.

  6 months

• 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.

  Baseline to 3 weeks

• Efficacy of Subsequent Radioiodine Therapy in Terms of Complete Response (CR)/Partial Response (PR)/Stable Disease (SD) of Any Radiographic Disease

  3 months

• Efficacy of Subsequent Radioiodine Therapy in Terms of Change in Serum Thyroglobulin Level

  6 months

Study Arms (1)

Treatment

EXPERIMENTAL

Starting dose 6 mg/m\^2 Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.

Drug: Decitabine; Radiation: Iodine I 131; Biological: Recombinant thyrotropin alfa; Radiation: Fludeoxyglucose F 18; Procedure: Positron emission tomography

Interventions

Decitabine DRUG

Starting dose 6 mg/m\^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.

Also known as: 5-aza-dCyd, 5AZA, DAC

Treatment

Iodine I 131 RADIATION

Undergo thyrotropin-alfa stimulated radioactive iodine scan

Also known as: I 131, Iodotope, Iodotrope

Treatment

Recombinant thyrotropin alfa BIOLOGICAL

Undergo thyrotropin-alfa stimulated radioactive iodine scan

Also known as: Thyrogen

Treatment

Fludeoxyglucose F 18 RADIATION

Optional correlative studies

Also known as: 18FDG, FDG

Treatment

Positron emission tomography PROCEDURE

Optional correlative studies

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

University of Colorado at Denver

Aurora, Colorado, 80045, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Official Website

MeSH Terms

Conditions

Thyroid Neoplasms; Adenocarcinoma, Follicular; Thyroid Cancer, Papillary

Interventions

Decitabine; Iodine-131; Thyrotropin Alfa; Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma, Papillary

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Thyrotropin; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Steven I. Sherman, MD / Professor
• Organization: University of Texas MD Anderson Cancer Center

sisherma@mdanderson.org

713-792-2841

Study Officials

• Steven Sherman

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2004
• First Posted: June 11, 2004
• Study Start: May 1, 2004
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 29, 2018
• Results First Posted: September 1, 2014

Record last verified: 2018-10

Locations

US (3)