Phase II Trial of Thalidomide in Refractory/Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin's Disease - Full Text View

Sponsors and Collaborators:	Emory University Celgene Corporation
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00209014

Purpose

Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part in this study. The purpose of this study is to find out what effects (good and bad) the drug thalidomide has on patients and the lymphoma.

Condition	Intervention	Phase
B-Cell Lymphoma Hodgkin's Disease	Drug: Thalidomide	Phase II

MedlinePlus related topics: Hodgkin's Disease Lymphoma

Drug Information available for: Thalidomide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Thalidomide in Refractory/Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin's Disease

Further study details as provided by Emory University:

Estimated Enrollment:	20
Study Start Date:	July 2003
Study Completion Date:	June 2006

Detailed Description:

Patients who have relapsed or refractory large B-cell lymphoma are being asked to take part in this study. This research is being done because current treatment does not help everyone with this disease. The purpose of this study is to find out what effects (good and bad) the drug thalidomide has on patients and the lymphoma. Thalidomide has been shown to have activity against other cancers but is not approved by the FDA for treatment of lymphoma. Thalidomide prevents growth of new blood vessels that allow cancer cells to receive nourishment and spread. Another reason for doing the study is that researchers want to learn more about how the drug works and whether some patients respond better than others.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with an expected survival period of 6 months or greater and who have been diagnosed with any stage of diffuse large B-cell lymphoma or Hodgkin's disease will be eligible to participate in this study. Final eligibility will be determined by the health professionals conducting this trial.

Exclusion Criteria:

Women who are pregnant, lactating or who refuse to have a pregnancy test will not be eligible for this study. Also, patients with an active infection, or a history of current or previous deep vein thrombosis and/or currently receiving anticoagulant therapy for deep vein thrombosis will be excluded from participation in this study. Final eligibility will be determined by the health professionals conducting this trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209014

Locations

United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Celgene Corporation

Investigators

Principal Investigator:

L. Thompson Heffner, MD

Emory University Winship Cancer Institute

More Information

Study ID Numbers:	0544-2003
Study First Received:	September 13, 2005
Last Updated:	December 17, 2007
ClinicalTrials.gov Identifier:	NCT00209014
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

B-Cell Lymphoma
Hodgkin's Disease

Study placed in the following topic categories:

Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Hodgkin's disease
Thalidomide
Hodgkin lymphoma, adult
Lymphoma, B-Cell
Lymphoma, large-cell

Lymphatic Diseases
B-cell lymphomas
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma
Hodgkin Disease

Additional relevant MeSH terms:

Anti-Infective Agents
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents

Angiogenesis Inhibitors
Pharmacologic Actions
Anti-Bacterial Agents
Neoplasms
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on January 16, 2009