Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 5:09 AM
Ignite Modification Date:
2025-12-25 @ 5:09 AM
NCT ID:
NCT00086827
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.
Study:
NCT00086827
Study Brief:
Protocol Section:
NCT00086827