PXD101 IN PATIENTS WITH RECURRENT OR REFRACTORY CUTANEOUS AND PERIPHERAL T-CELL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is an open-label, non-randomized, multicenter, Phase II trial to assess the efficacy and safety of an investigational drug, PXD101, monotherapy in patients who have failed at least one line of prior therapy. The trial design includes two arms; arm A comprises only patients with recurrent Cutaneous T-cell lymphoma (CTCL), and arm B comprises patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL) or other T-cell lymphomas. PXD101 is a promising antineoplastic agent for the treatment of hematological neoplasias, and is currently being evaluated in a Phase II clinical trial for the treatment of multiple myeloma. Further clinical trials in patients with Non-Hodgkin's lymphomas (NHL) will delineate the optimal use of PXD101 in these disorders. The primary objective of this trial is to determine the efficacy of PXD101 treatment as measured by response rate (CR=complete response; CRu=CR/unconfirmed; PR=partial response; SD=stable disease; RD=relapsed disease; or PD=progressive disease) using the response criteria of Cheson et al. (Cheson 1999). The secondary objective of the trial is to examine the time to response, the duration of response, and the safety and survival following PXD101 therapy as a single agent.