An Investigational Drug Study With Suberoylanilide Hydroxamic Acid in Relapsed Diffuse Large B-cell Lymphoma (0683-013)

B-cell Lymphoma Clinical Trial

Official title:

A Phase II Clinical Trial of Oral Suberoylanilide Hydroxamic Acid (SAHA) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097929
• Other study ID #: 0683-013
• Secondary ID: MK0683-0132004_0
• Status: Completed
• Phase: Phase 2
• First received: December 1, 2004
• Last updated: April 5, 2017
• Start date: May 1, 2005
• Est. completion date: July 31, 2006

Study information

• Verified date: April 2017
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Other known NCT identifiers

• NCT00124631

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 31, 2006
• Est. primary completion date: July 31, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA) / Duration of Treatment 6 Months

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Crump M, Coiffier B, Jacobsen ED, Sun L, Ricker JL, Xie H, Frankel SR, Randolph SS, Cheson BD. Phase II trial of oral vorinostat (suberoylanilide hydroxamic acid) in relapsed diffuse large-B-cell lymphoma. Ann Oncol. 2008 May;19(5):964-9. doi: 10.1093/annonc/mdn031. Epub 2008 Feb 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate based on FDG-PET and CT scan findings.
Secondary	Response duration, Progression-free survival, Time to progression, Time to response, 3-Month and 6-month progression free survival.