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

Completed · Phase 2

Conditions studied: Recurrent Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Papillary Thyroid Cancer

In brief

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

Key facts

Study ID

NCT00098813

Run by

National Cancer Institute (NCI)

People needed

20

Starts

2004-10-01

Expected to finish

2009-08-01

Last updated by the study team

2014-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed non-medullary thyroid carcinoma, including the following cell types:
• Papillary
• Follicular
• Variants of papillary or follicular
• Hürthle cell
• Recurrent and/or metastatic disease
• Measurable disease
• At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
• Progressive disease during or after prior treatment, as defined by >= 1 of the following criteria:
• Presence of new or progressive lesions on CT scan or MRI
• New lesions on bone or positron-emission tomography scan
• Rising thyroglobulin level
• Minimum of 3 consecutive rises with an interval of >= 1 week between each determination
• Refractory to radioactive iodine (RAI)
• Absent or insufficient RAI-uptake documented by whole-body RAI scan within the past 6 months
• At least 1 lesion with absent RAI-uptake required for insufficient uptake
• No known brain metastases
• Performance status - Karnofsky 60-100%
• WBC >= 3,000/mm\^3
• Absolute neutrophil count >= 1,500/mm\^3
• Platelet count >= 100,00/mm\^3
• Bilirubin normal
• AST and ALT =< 2.5 times upper limit of normal
• Chronic active viral hepatitis allowed provided patient is clinically stable and fulfills liver function eligibility criteria
• Creatinine normal

Where it is running

• Memorial Sloan-Kettering Cancer Center at Suffolk — Commack, New York, United States

Full record on ClinicalTrials.gov

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