Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine
Condition: Recurrent Thyroid Cancer; Stage IV Follicular Thyroid Cancer; Stage IV Papillary Thyroid Cancer
MeSH terms: Thyroid Neoplasms; Thyroid Cancer, Papillary; Adenocarcinoma, Follicular; Thyroid Diseases
Intervention: romidepsin; laboratory biomarker analysis; positron emission tomography
Intervention description: Given IV; Correlative studies; Correlative studies
Intervention MeSH terms: Romidepsin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  Creatinine clearance >= 60 mL/min

          -  QTc =< 480 msec by ECG

          -  ST segment depression < 2 mm

          -  LVEF >= 50 % by echocardiogram

          -  No left ventricular hypertrophy, as defined by end-diastolic wall thickness > 12 mm in
             both the left ventricular posterior wall as well as septum or restrictive
             cardiomyopathy

          -  No history of any of the following cardiac diseases:

               -  Canadian Cardiovascular Society (CCS) class II-IV angina pectoris

               -  Myocardial infarction within the past 12 months

               -  Sustained ventricular tachycardia, ventricular fibrillation, Torsade de Pointes,
                  or cardiac arrest unless currently addressed with an automatic implantable
                  cardioverter defibrillator

               -  Any cardiac arrhythmia requiring digitalis or another antiarrhythmic medication
                  other than a beta blocker or calcium channel blocker

               -  No uncontrolled hypertension (i.e., blood pressure >= 160/95)

               -  Mobitz II second degree block in patients who do not have a pacemaker

                    -  First degree or Mobitz I second degree block, bradyarrhythmias or sick sinus
                       syndrome require Holter monitoring and evaluation by cardiology

               -  Uncontrolled dysrhythmias

          -  No history of congenital long QT syndrome

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Thyroid stimulating hormone normal or suppressed

          -  No history of allergic reaction attributed to compounds of similar chemical or
             biologic composition to FR901228

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study participation

          -  No other concurrent uncontrolled illness

          -  At least 4 weeks since prior biologic or targeted agents (e.g., interferon alfa,
             thalidomide, octreotide, or cetuximab)

          -  No concurrent antineoplastic biologic agents

          -  No prior FR901228 (depsipeptide)

          -  No prior cytotoxic chemotherapy

               -  Cytotoxic chemotherapy as a radiosensitizer allowed provided >= 3 months since
                  prior administration

          -  No other concurrent antineoplastic chemotherapy

          -  Not specified

          -  At least 4 weeks since prior external beam radiation therapy

               -  Documented disease progression required if patient received external beam
                  radiotherapy to index lesions

          -  At least 3 months since prior RAI therapy

               -  Diagnostic studies using =< 12 mCi of RAI are not considered RAI therapy

          -  No concurrent antineoplastic radiotherapy

          -  At least 2 weeks since prior anticancer cyclooxygenase-2 (COX-2) inhibitors,
             isotretinoin, or complementary medications

          -  At least 4 weeks since prior tyrosine kinase inhibitors (e.g., gefitinib or erlotinib)

          -  No other concurrent investigational agents

          -  No other concurrent anticancer therapy

          -  No concurrent drugs known to have histone deacetylase inhibitor activity (e.g.,
             valproic acid)

          -  No concurrent combination anti-retroviral therapy for HIV-positive patients

          -  No concurrent hydrochlorothiazide

          -  No concurrent treatment dose warfarin

          -  No concurrent agents that cause QTc prolongation

          -  Concurrent daily aspirin given after myocardial infarction or COX-2 inhibitors at
             standard anti-inflammatory or pain doses allowed