Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-26 @ 4:14 AM
Study NCT ID:
NCT00086827
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2004-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Romidepsin in Treating Patients With Relapsed Small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Study of Single Agent Depsipeptide (FK228) (NSC 630176; IND 51,810) in Relapsed Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 recurrent small cell lung cancer. FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
Detailed Description:
PRIMARY OBJECTIVES:
I. To evaluate the response rate of patients with histologically or cytologically proven small cell lung cancer (SCLC) treated with depsipeptide in the "sensitive" relapse setting.
SECONDARY OBJECTIVES:
I. To describe the overall survival and failure-free survival of patients with histologically proven recurrent SCLC treated with depsipeptide.
II. To evaluate the toxicity of depsipeptide in patients with relapsed SCLC. III. To evaluate surrogate biological markers from peripheral blood mononuclear cells and buccal epithelial cells: p53 acetylation, histone acetylation, p21CIP1 expression.
OUTLINE:
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have continuing tumor response or stable disease after 6 courses receive 2 additional courses beyond best response.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
I. To evaluate the response rate of patients with histologically or cytologically proven small cell lung cancer (SCLC) treated with depsipeptide in the "sensitive" relapse setting.
SECONDARY OBJECTIVES:
I. To describe the overall survival and failure-free survival of patients with histologically proven recurrent SCLC treated with depsipeptide.
II. To evaluate the toxicity of depsipeptide in patients with relapsed SCLC. III. To evaluate surrogate biological markers from peripheral blood mononuclear cells and buccal epithelial cells: p53 acetylation, histone acetylation, p21CIP1 expression.
OUTLINE:
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have continuing tumor response or stable disease after 6 courses receive 2 additional courses beyond best response.
Patients are followed every 3 months for 1 year and then every 6 months for 3 years.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2012-02785 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| CALGB-30304 | OTHER | Cancer and Leukemia Group B | View | |
| CALGB-30304 | OTHER | CTEP | View | |
| P30CA014236 | NIH | None | https://reporter.nih.gov/quic… | View |
| U10CA031946 | NIH | None | https://reporter.nih.gov/quic… | View |