Romidepsin in Treating Patients With Relapsed Small Cell Lung Cancer

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00086827
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 2
Start date	May 2004

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01935336` - Study of Ponatinib in Patients With Lung Cancer Preselected Using Different Candidate Predictive Biomarkers	Phase 2
Completed	`NCT01931787` - CPI-613 in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer	Phase 1
Terminated	`NCT01217411` - RO4929097 and Whole-Brain Radiation Therapy or Stereotactic Radiosurgery in Treating Patients With Brain Metastases From Breast Cancer	Phase 1
Terminated	`NCT04610658` - Immune Checkpoint Inhibition With Lurbinectedin Relapsed/Recurrent SCLC	Phase 1
Completed	`NCT00773955` - R-(-)-Gossypol Acetic Acid in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer	Phase 2
Completed	`NCT00528645` - AZD0530 in Treating Patients With Extensive Stage Small Cell Lung Cancer	Phase 2
Completed	`NCT00028535` - Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors	Phase 1
Recruiting	`NCT03732846` - Anlotinib in Treatment of Recurrent Small Cell Lung Cancer	Phase 2
Active, not recruiting	`NCT00828139` - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer	Phase 2
Completed	`NCT00052949` - Imatinib Mesylate in Treating Patients With Recurrent Small Cell Lung Cancer	Phase 2
Withdrawn	`NCT01325753` - Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body	N/A
Not yet recruiting	`NCT05162196` - The Efficacy and Safety of Radiotherapy Plus Niraparib and Toripalimab in Patients With Recurrent Small Cell Lung Cancer	Phase 2
Completed	`NCT01155258` - Temsirolimus and Vinorelbine Ditartrate in Treating Patients With Unresectable or Metastatic Solid Tumors	Phase 1
Terminated	`NCT00088933` - Vaccine Therapy and Sargramostim With or Without Docetaxel in Treating Patients With Metastatic Lung Cancer or Metastatic Colorectal Cancer	Phase 1
Completed	`NCT00020202` - FR901228 in Treating Patients With Refractory or Progressive Small Cell Lung Cancer or Non-small Cell Lung Cancer	Phase 2
Completed	`NCT01901653` - Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer	Phase 1/Phase 2
Completed	`NCT00182689` - Sorafenib in Treating Patients With Extensive Stage Small Cell Lung Cancer	Phase 2
Completed	`NCT01457469` - Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer	Phase 1
Completed	`NCT00098956` - 7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer	Phase 2
Terminated	`NCT01803269` - Topotecan Hydrochloride or Cyclodextrin-Based Polymer-Camptothecin CRLX101 in Treating Patients With Recurrent Small Cell Lung Cancer	Phase 2