Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084461
Status:
TERMINATED
Last Update Posted:
2013-06-04
First Post:
2004-06-10
Brief Title:
Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Depsipeptide in Metastatic Neuroendocrine Tumors
Status:
TERMINATED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
PRIMARY OBJECTIVES
I Determine objective response rate in patients with locally advanced or metastatic neuroendocrine tumors treated with FR901288 romidepsin
SECONDARY OBJECTIVES
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
OUTLINE
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
I Determine objective response rate in patients with locally advanced or metastatic neuroendocrine tumors treated with FR901288 romidepsin
SECONDARY OBJECTIVES
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
OUTLINE
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01CA076576 | NIH | None | httpsreporternihgovquickSearchU01CA076576 |
| 0425 | None | None | None |
| NCI-6325 | None | None | None |
| OSU-2003C0085 | None | None | None |
| CDR0000365313 | None | None | None |