An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00097929
First received: December 1, 2004
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
B-Cell Lymphoma
Drug: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Objective response rate based on FDG-PET and CT scan findings.

Secondary Outcome Measures:
  • Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.

Estimated Enrollment: 50
Study Start Date: May 2005
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00097929

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00097929     History of Changes
Obsolete Identifiers: NCT00124631
Other Study ID Numbers: 2004_029, MK0683-013
Study First Received: December 1, 2004
Last Updated: January 21, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck Sharp & Dohme Corp.:
Relapsed Diffuse Large B-cell Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Vorinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014