Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
Gastrinoma, Glucagonoma, Insulinoma
About this trial
This is an interventional treatment trial for Gastrinoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed carcinoid tumor or islet cell neuroendocrine tumor Well- or moderately-differentiated tumor Metastatic and/or locally advanced disease Measurable disease Unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Lesions in a previously irradiated area are not considered measurable No truly non-measurable lesions, including the following: Bone lesions Leptomeningeal disease Ascites Pleural or pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging Cystic lesions Ineligible for standard treatment Performance status - ECOG 0-1 At least 6 months WBC >= 3,000/mm^3 Absolute neutrophil count >= 1,500/mm^3 Platelet count >= 100,000/mm^3 Bilirubin =< 1.5 mg/dL AST and ALT =< 2.5 times upper limit of normal Creatinine =< 1.5 mg/dL No New York Heart Association class III or IV congestive heart failure No myocardial infarction within the past year No uncontrolled dysrhythmias No poorly controlled angina No serious ventricular arrhythmia, defined as ventricular tachycardia or ventricular fibrillation >= 3 beats in a row No left ventricular hypertrophy by EKG No other significant cardiac disease QTc < 500 msec LVEF > 40% by resting MUGA No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drug No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception More than 4 weeks since prior immunotherapy (e.g., interferon alfa) More than 4 weeks since prior chemotherapy More than 12 weeks since prior hepatic artery chemoembolization unless liver lesions are not the only indicator lesions No prior FR901228 (depsipeptide) No more than 1 prior systemic chemotherapy regimen for carcinoid or islet cell tumor (other than hepatic artery chemoembolization) More than 4 weeks since prior oral or IV steroids (first 16 patients only) Concurrent long-acting octreotide allowed at standard doses if dose has been stable for the past 12 weeks Concurrent subcutaneous octreotide for breakthrough use for symptomatic relief allowed No concurrent systemic steroids (first 16 patients only) More than 4 weeks since prior radiotherapy More than 4 weeks since prior investigational tumor-specific therapy No other prior histone deacetylase inhibitors (e.g., valproic acid) No concurrent hydrochlorothiazide No concurrent combination antiretroviral therapy for HIV-positive patients No other concurrent investigational or commercial agents or therapies for the malignancy
Sites / Locations
- Ohio State University Medical Center
Arms of the Study
Arm 1
Experimental
Treatment (romidepsin)
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses beyond CR.