Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:53 AM
Ignite Modification Date:
2025-12-24 @ 11:53 AM
NCT ID:
NCT00084461
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00084461
Study Brief:
Protocol Section:
NCT00084461