A Phase 2 Clinical Trial Testing Dpx-Survivac And Metronomic Low Dose Cyclophosphamide As Immunotherapy For Patients With Recurrent Diffuse Large B-Cell Lymphoma.

e14578Background: Survivin is strongly expressed in tumors of about 60% of diffuse large B-cell lymphoma (DLBCL) patients. DPX-Survivac contains survivin HLA class I peptides in a novel formulation, DepoVax. A phase 1 trial in ovarian cancer patients demonstrated the safety and immunogenicity of DPX-Survivac therapy. A phase 2 trial was initiated to determine the objective response rate, immunogenicity and safety in patients with recurrent, survivin-expressing DLBCL who are not eligible for transplant, or who have recurred after transplant. Methods: 24 subjects with confirmed survivin-positive DLBCL with LDH’s less than 2x normal, are to be enrolled in this study. Patients receive two 0.25 mL priming doses of DPX-Survivac three weeks apart and up to six 0.1 mL boosting doses eight weeks apart in combination with low dose oral metronomic cyclophosphamide. Subjects will be treated for one year or until disease progression. The objective response rate is measured using Modified Cheson criteria. Biopsy and bl...