Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase I Study of the Combination of Lenalidomide With the Histone Deacetylase Inhibitor, Vorinostat in Hodgkin and Non Hodgkin's Lymphoma
RATIONALE: Vorinostat may stop the growth of cancer cells by blocking some of the enzymes
needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune
system in different ways and stop cancer cells from growing. Giving vorinostat together with
lenalidomide may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of vorinostat when
given together with lenalidomide in treating patients with relapsed or refractory Hodgkin
lymphoma or non-Hodgkin lymphoma.
PRIMARY OBJECTIVES:
I. To assess the safety and tolerability of the combination of lenalidomide and vorinostat.
II. To determine the maximum tolerated dose (MTD) and recommended dose of vorinostat and
lenalidomide when given in combination in this patient population.
SECONDARY OBJECTIVES:
I. To obtain preliminary data for response rate, time to response, response duration and
time to progression (TTP) for vorinostat and lenalidomide when used in combination.
OUTLINE: This is a dose-escalation study of vorinostat.
Patients receive oral vorinostat twice daily on days 1-14 and oral lenalidomide once daily
on days 1-21. Courses repeat every 21 days in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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