Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
Stopped early · Phase 2
Conditions studied: Gastrinoma, Glucagonoma, Insulinoma, Metastatic Gastrointestinal Carcinoid Tumor, Pancreatic Polypeptide Tumor, Pulmonary Carcinoid Tumor, Recurrent Gastrointestinal Carcinoid Tumor, Recurrent Islet Cell Carcinoma, Regional Gastrointestinal Carcinoid Tumor, Somatostatinoma
In brief
Phase II trial to study the effectiveness of romidepsin in treating patients who have locally advanced or metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.
Key facts
- Study ID
- NCT00084461
- Run by
- National Cancer Institute (NCI)
- People needed
- 25
- Starts
- 2004-03-01
- Last updated by the study team
- 2013-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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