PS-341 IN PATIENTS WITH ADVANCED MALIGNANCIES AND RENAL DYSFUNCTION

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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 a multi-center, Phase I study of the CTEP-sponsored Organ Dysfunction Working Group. The objectives of this study are to: 1) identify the pharmacokinetic and pharmacodynamic profile of PS-341 in patients with advanced malignancy and mild, moderate or severe renal insufficiency, and 2) evaluate the safety, tolerability, and the maximum tolerated dose of PS-341 for patients with varying degrees of renal insufficiency. Subjects will be divided into 5 treatment groups based on creatinine clearance measurements. Each group will have a different starting dose of PS-341. Subjects will receive PS-341 through an IV infusion of normal saline over 30 minutes on Days 1, 4, 8 and 11, followed by a week without treatment. One cycle is 21 days and cycles may be repeated until disease progression. During Cycle 1 only, subjects will receive treatment at the GCRC and pharmacokinetic samples will be drawn. Doses will be increased according to the dose escalation plan detailed in the protocol. Doses will not be escalated in any individual patient. This study will enroll a total of approximately 69 subjects at 11 U.S. medical centers (10 subjects are expected at this site).