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


Phase 2
18 Years
N/A
Not Enrolling
Both
B-Cell Lymphoma, Hodgkin's Disease

Thank you

Trial Information

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. 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.


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.

Type of Study:

Interventional

Study Design:

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

Principal Investigator

L. Thompson Heffner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

0544-2003

NCT ID:

NCT00209014

Start Date:

July 2003

Completion Date:

June 2006

Related Keywords:

  • B-Cell Lymphoma
  • Hodgkin's Disease
  • B-Cell Lymphoma
  • Hodgkin's Disease
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location

Emory University Winship Cancer InstituteAtlanta, Georgia  30322