A study to determine the safety, tolerability, and anti-tumor effectiveness of an oral investigational drug in the treatment of relapsed diffuse large B-cell lymphoma.

Condition	Treatment or Intervention	Phase
B-Cell Lymphoma	Drug: Suberoylanilide Hydroxamic Acid (SAHA)	Phase II Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patient must be 18 years or older with relapsed Diffuse Large B-cell Lymphoma (DLBCL).
• Stable disease or better for at least 3 months on most recent treatment
• Have not received any chemotherapy, radiation therapy, major surgery, or any other investigational therapy for at least 4 weeks prior to entry in this study
• Adequate blood testing, liver, and kidney function as required by the study.
• Eligible subjects will allow tissue samples to be examined and stored.

Exclusion Criteria:

• Patient has been treated with other investigational agents with a similar anti-tumor mechanism.
• Patient should not have failed more than 3 prior treatment regimens.

Toll Free Number      1-888-577-8839 

Colorado
      Call for Information, Denver,  Colorado,  80218,  United States; Recruiting
New Jersey
      Call for Information, Hackensack,  New Jersey,  07650,  United States; Recruiting
New York
      Call for Information, New York,  New York,  10021,  United States; Recruiting
Pennsylvania
      Call for International Site Information, Horsham,  Pennsylvania,  19044,  United States; Recruiting
Tennessee
      Call for Information, Nashville,  Tennessee,  37203,  United States; Recruiting

Study ID Numbers:  2004_029
Record last reviewed:  March 2005
Last Updated:  March 25, 2005
Record first received:  December 1, 2004
ClinicalTrials.gov Identifier:  NCT00097929
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08