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

Sponsor

Emory University (Other)

Overall Status

Terminated

CT.gov ID

NCT00209014

Collaborator

Celgene Corporation (Industry)

Enrollment

Location

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
B-Cell Lymphoma Hodgkin's Disease	Drug: Thalidomide	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2003

Actual Study Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.