NCT00098813

Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine

A Phase II Study of Single Agent Depsipeptide (FK228) in Radioiodine (RAI)-Refractory Metastatic Non-medullary (Papillary, Follicular, and Hurthle Cell Variants) Thyroid Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial is studying how well romidepsin works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine. Romidepsin may stop the growth of tumor cells by blocking the some of the enzymes needed for cell growth. It may also help radioactive iodine and chemotherapy work better by making tumor cells more sensitive to the drug

Detailed description

PRIMARY OBJECTIVES: I. Determine the antitumor activity of romidepsin (depsipeptide), in terms of the proportion of patients achieving a complete or partial response or disease stabilization, in patients with progressive recurrent and/or metastatic non-medullary thyroid carcinoma that is refractory to radioactive iodine (RAI). II. Determine the safety and tolerability of this drug in these patients. SECONDARY OBJECTIVES: I. Document changes in RAI uptake by comparing pre- and post-treatment RAI scans in patients treated with this drug. II. Evaluate changes in the expression of the Na+/I- symporter (NIS) in tumors, as measured by immunohistochemistry on pre- and post-treatment biopsy specimens; and real time reverse transcriptase polymerase chain reaction (RT-PCR) for NIS mRNA on pre- and post-treatment changes biopsy specimens. III. Determine post-treatment changes in serum thyroglobulin in patients treated with this drug. IV. Correlate changes in post-treatment positron-emission tomography scans with whole-body RAI scans in patients treated with this drug. OUTLINE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.

Conditions

• Recurrent Thyroid Cancer
• Stage IV Follicular Thyroid Cancer
• Stage IV Papillary Thyroid Cancer

Interventions

Type	Name	Description
DRUG	romidepsin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies
PROCEDURE	positron emission tomography	Correlative studies

Timeline

• Start date: 2004-10-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2004-12-09
• Last updated: 2014-05-28
• Results posted: 2013-12-19

Locations

1 site across 1 country: United States