Status:
COMPLETED
Romidepsin in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Has Not Responded to Radioactive Iodine
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Recurrent Thyroid Cancer
Stage IV Follicular Thyroid Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 gro...
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 pati...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00098813
Start Date
October 1 2004
End Date
August 1 2009
Last Update
May 28 2014
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center at Suffolk
Commack, New York, United States, 11725