Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
|ClinicalTrials.gov Identifier: NCT00084461|
Recruitment Status : Terminated
First Posted : June 11, 2004
Last Update Posted : June 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|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||Drug: romidepsin Other: laboratory biomarker analysis||Phase 2|
I. Determine objective response rate in patients with locally advanced or metastatic neuroendocrine tumors treated with FR901288 (romidepsin).
I. Determine the toxicity of this drug in these patients. II. To measure serum tumor markers (pancreastatin, gastrin, pancreatic polypeptide, glucagon, substance-P, neurotensin, calcitonin, somatostatin, vasoactive intestinal peptide, gastrin releasing polypeptide, ACTH) depending on the tumor type pre-, during-, and post-treatment.
III. To perform a nuclear medicine functional imaging scan (octreoscan) to evaluate the disease status pre-, during-, and post-treatment.
IV. To perform histone acetylation assay in cytospins from peripheral blood mononuclear cells (PBMCs) to correlate with disease response and with immunologic parameters.
V. To quantify gene expression by Real Time PCR of type 1 and type 2 cytokines, co-stimulatory molecules, and adhesion molecules in PBMCs obtained from the pre-, during-, and post-treatment blood samples.
VI. To perform a multicolor flow cytometric analysis on fresh blood to assess activation of lymphocyte subsets and presence of co-stimulatory and adhesion molecules.
VII. To perform in vitro functional assays for innate as well as antigen-specific T cell immune responses in PBMCs obtained from the pre-, during-, and post-treatment blood samples.
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 complete remission (CR) receive 2 additional courses beyond CR.
Patients are followed at 2-4 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Depsipeptide in Metastatic Neuroendocrine Tumors|
|Study Start Date :||March 2004|
|Primary Completion Date :||October 2004|
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.
Other Names:Other: laboratory biomarker analysis
- Objective response rate [ Time Frame: Up to 4 weeks ]Frequency of response will be estimated with a 95% confidence interval.
- Incidence of toxicity [ Time Frame: Up to 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00084461
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Manisha Shah||Ohio State University|