Recurrent Adult Hodgkin Lymphoma Clinical Trial
Official title:
A Phase II Trial of Suberoylanilide Hydroxamic Acid (NSC-701852) for Recurrent or Primary Refractory Hodgkin's Lymphoma
This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory advanced Hodgkin's lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To evaluate the response probability (complete, complete unconfirmed, and partial) in
patients with relapsed or refractory Hodgkin's lymphoma.
II. To estimate 1-year progression-free survival and overall survival in patients with
relapsed or refractory Hodgkin's lymphoma treated with SAHA.
III. To assess the toxicity profile of SAHA in this patient population. IV. To perform gene
expression profiling on tumor tissue before and after treatment in order to explore in a
preliminary manner the association between response and specific gene expression results.
OUTLINE: This is a multicenter study.
Patients receive oral vorinostat twice daily on days 1-14. Treatment repeats every 21 days
in the absence of disease progression or unacceptable toxicity. Patients achieving a
complete response (CR) receive 2 additional courses of therapy beyond CR.
After completion of study treatment, patients are followed every 6 months for 2 years and
then annually for 3 years.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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