NCT00086827

Romidepsin in Treating Patients With Relapsed Small Cell Lung Cancer

A Phase II Study of Single Agent Depsipeptide (FK228) (NSC 630176; IND 51,810) in Relapsed Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	romidepsin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2004-05-01
• Primary completion: 2006-11-01
• First posted: 2004-07-12
• Last updated: 2014-04-10

Locations

1 site across 1 country: United States