Recurrent Mantle Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Suberoylanilide Hydroxamic Acid (SAHA) in Indolent Non-Hodgkin's Lymphoma
This phase II trial is studying how well vorinostat works in treating patients with relapsed or refractory indolent non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as vorinostat, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To evaluate the anti-tumor activity of SAHA (vorinostat) as assessed by the objective
response rate, time to progression and survival in subjects with advanced lymphoma.
II. To assess the toxicity profile of SAHA in this patient population. III. To perform
correlative laboratory investigations to confirm modulation of chromatin acetylation as the
biologic target and attempt to gain insight into the downstream molecular mechanisms involved
in the induction of apoptosis mediated by SAHA.
OUTLINE:
Patients receive vorinostat orally (PO) twice daily (BID) on days 1-14. Treatment repeats
every 21 days for up to 12 courses in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 3 months for 1 year and
then every 6 months for 2 years.
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|---|---|---|---|
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