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

This study has been terminated.
(Celgene unable to continue funds.)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00209014
First received: September 13, 2005
Last updated: May 6, 2009
Last verified: May 2009

September 13, 2005
May 6, 2009
July 2003
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Complete list of historical versions of study NCT00209014 on ClinicalTrials.gov Archive Site
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Phase II Trial of Thalidomide in Refractory/Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin's Disease
Phase II Trial of Thalidomide in Refractory/Relapsed Diffuse Large B-Cell Lymphoma and Hodgkin's Disease

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • B-Cell Lymphoma
  • Hodgkin's Disease
Drug: Thalidomide
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
June 2006
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00209014
0544-2003
Not Provided
Leonard Heffner, MD, Emory University Winship Cancer Institute
Emory University
Celgene Corporation
Principal Investigator: L. Thompson Heffner, MD Emory University Winship Cancer Institute
Emory University
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP