| Budget Amount *help |
¥4,290,000 (Direct Cost: ¥3,300,000、Indirect Cost: ¥990,000)
Fiscal Year 2009: ¥1,560,000 (Direct Cost: ¥1,200,000、Indirect Cost: ¥360,000)
Fiscal Year 2008: ¥2,730,000 (Direct Cost: ¥2,100,000、Indirect Cost: ¥630,000)
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| 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.
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