Non-Hodgkin Lymphoma Clinical Trial
Official title:
Phase II Study of Combination Vorinostat and Bortezomib in Patients With Relapsed and/or Refractory Non-Hodgkin Lymphoma
The purpose of this study is to determine the rate of response to the drugs bortezomib (Velcade) and vorinostat (Zolinza), when used in combination, in patients with relapsed (recurrent) and/or refractory (difficult to treat) non-Hodgkin Lymphoma, and to determine the safety and tolerability of this regimen.
More selective and less toxic therapeutic strategies are needed to improve cure rates and
prolong survival in patients with relapsed and/or refractory non-Hodgkin Lymphoma.
Amongst the multiple new pathways recently studied two have emerged as potentially important
targets for new agents in lymphoma. These include the ubiquitin proteasome pathway and the
biochemical reactions that control histone acetylation. The first two agents in each class to
have been studied in lymphomas are: bortezomib and vorinostat. Bortezomib has been granted
FDA approval for the treatment of mantle cell lymphoma and has established activity in a
variety of B-cell lymphomas including follicular, marginal zone and diffuse large B-cell
lymphoma. Vorinostat or SAHA (suberoylanilide hydroxamic acid) has been FDA approved for the
treatment of refractory cutaneous T-cell lymphomas and has also shown activity in other
lymphomas.
Synergistic activity between vorinostat and bortezomib has been observed in different cell
lines. The proposed study will be a phase II trial of the combination of vorinostat and
bortezomib at the recommended dose-schedule in patients with recurrent and/or refractory
lymphomas, indolent and aggressive, and B or T.
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