CLINICAL TRIAL: SGN-40 (ANTI-HUCD40 MAB) IN RELAPSED DIFFUSE LARGE B-CELL LYMPHO

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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 phase II, open-label, multidose tiral to define the antitumor activity and the safety profile of single-agent SGN-40 in patients with relapsed DLBCL. Up to 35 evaluable patients will be enrolled at 6 to 10 US sites. 6-8 subjects will take part in this study at this institution. All patients in Cycle 1 will receive six intravenous (IV) infusions of SGN-40 over five weeks, using a previously tested dose-loading schedule. Patients will be premedicated with diphenhydramine and acetaminophen before each infusion. In addition, patients will be provided with and instructed to take a short course of prednisone if inflammatory symptoms develop after the infusion. Patients who meet criteria for clinical benefit may receive a second cycle of therapy beginning 14 days after the last dose. Patients who continue to exhibit clinical benefit after Cycle 2 may continue to receive additional therapy up to a total of six cycles of SGN-40. Cycles 3-6 must begin within 21 days of the last infusion of the previous cycle. Treatment may continue until disease progression is observed or two cycles beyond radiographically documented (CT and PET scan) complete response. Clinical benefit is defined as stable disease, partial resonse or complete response based on imaging studies and absence of significant unresolved toxicity at the time that the next cycle is scheduled to begin.