Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00084682
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2004-06-10
Brief Title:
Depsipeptide in Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Single Agent Depsipeptide FK228 NSC 630176 IND 51810 in Patients With Unresectable Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2021-02
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:
This phase II trial is studying how well FR901228 works in treating patients with unresectable recurrent or metastatic squamous cell carcinoma cancer of the head and neck Drugs used in chemotherapy such as FR901228 work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate the rate of disease control ie achievement of complete response partial response or stable disease of the single agent depsipeptide in patients with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck
SECONDARY OBJECTIVES
I To evaluate the duration of response time to progression and overall survival for patients with incurable head and neck cancer treated with depsipeptide
TERTIARY OBJECTIVES
I To determine the extent of histone hyperacetylation in peripheral blood mononuclear cells PBMCs as a readout of depsipeptide activity before and after depsipeptide administration to correlate this activity with observed histone hyperacetylation in tumor and mucosal cells and to correlate extent of depsipeptide activity with tumor response
II To determine depsipeptide-induced changes in the gene expression profile of tumor cells from biopsies of accessible tumor tissue and of mucosal cells from transepithelial oral brush biopsies using cDNA microarrays containing 28000 clones and to correlate these changes with extent of histone hyperacetylation observed in PBMCs and tumor tissues
III To determine depsipeptide-induced changes in methylation of candidate genes in tumor cells and oral mucosa epithelia
IV To demonstrate altered expression of signaling and cell cycle-related proteins in tumor tissue in response to depsipeptide
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
I To evaluate the rate of disease control ie achievement of complete response partial response or stable disease of the single agent depsipeptide in patients with unresectable recurrent or metastatic squamous cell carcinoma of the head and neck
SECONDARY OBJECTIVES
I To evaluate the duration of response time to progression and overall survival for patients with incurable head and neck cancer treated with depsipeptide
TERTIARY OBJECTIVES
I To determine the extent of histone hyperacetylation in peripheral blood mononuclear cells PBMCs as a readout of depsipeptide activity before and after depsipeptide administration to correlate this activity with observed histone hyperacetylation in tumor and mucosal cells and to correlate extent of depsipeptide activity with tumor response
II To determine depsipeptide-induced changes in the gene expression profile of tumor cells from biopsies of accessible tumor tissue and of mucosal cells from transepithelial oral brush biopsies using cDNA microarrays containing 28000 clones and to correlate these changes with extent of histone hyperacetylation observed in PBMCs and tumor tissues
III To determine depsipeptide-induced changes in methylation of candidate genes in tumor cells and oral mucosa epithelia
IV To demonstrate altered expression of signaling and cell cycle-related proteins in tumor tissue in response to depsipeptide
OUTLINE This is a multicenter study
Patients receive FR901228 depsipeptide IV over 4 hours on days 1 8 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years
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 |
|---|---|---|---|
| N01CM62204 | NIH | Montefiore Medical Center | httpsreporternihgovquickSearchN01CM62204 |
| MMC 04-02-025S | OTHER | None | None |