2009 Fiscal Year Final Research Report

Development of an immune therapy against advanced solid tumors using the epitope peptides derived from novel tumor-associated antigens

Research Project

Project/Area Number	20790498
Research Category	Grant-in-Aid for Young Scientists (B)
Allocation Type	Single-year Grants
Research Field	Gastroenterology
Research Institution	Kyushu University
Principal Investigator	MUTSUNORI Iga Kyushu University, 大学病院, 助教 (20422420)
Project Period (FY)	2008 – 2009
Keywords	胆道学 / 膵臓学
Research Abstract	This is an open-label, Phase I dose-escalation study targeting HLA-A^2402- positive patients with advanced, metastatic, and/or recurrent gastrointestinal cancer, cholangiocellular carcinoma, pancreatic cancer, small cell and non-small cell lung cancer, and cervical cancer. The study treatments include pre-administration of cyclophosphamide (CPM) to exclude regulatory T cells, vaccination with five HLA-A^2402 restricted peptides derived from tumor-associated antigens, followed by administration of low-dose IL-2. The primary endpoint of safety was investigated in a CPM dose-escalation study that included a cohort of three patients. The secondary endpoint was to observe the induction of antigen-specific immune responses and clinical antitumor response. Twenty-two patients satisfying the eligibility criteria enrolled in this study, and the vaccination protocol was found to be well tolerated in 17 enrolled patients. Stable disease (SD) was observed in 8 of 15 patients. Immunological analysis will be demonstrated in these patients.