Phase I Study of Chemoradiation Therapy With Epitope Peptide Vaccine Therapy in Treating Patients With Unresectable, Advanced or Recurrent Esophageal Cancer
Up-regulated ling cancer 10 (URLC10), TTK protein kinase (TTK) and K homology domain
containing protein over expressed in cancer (KOC1) were identified as new targets of tumor
associated antigens using cDNA microarray technologies combined with the expression profiles
of normal and cancer tissues. Furthermore, anti-angiogenic therapy is now considered to be
one of promising approaches for treating cancer. Vascular endothelial growth factor receptor
1 (VEGFR1) and vascular endothelial growth factor receptor 2 (VEGFR2) are essential targets
for tumor angiogenesis. Epitope peptides for these targets are able to induce cytotoxic T
lymphocytes (CTL) restricted to HLA-A *2402 in vivo. On the other hand, chemotherapy
(CDDP, 5-FU) plus radiation therapy has been to be a standard treatment for unresectable
advanced esophageal cancer. In this clinical trial, we evaluate the safety and immune
responses of different doses of multiple peptides (URLC10, TTK, KOC1, VEGFR1, and VEGFR 2)
emulsified with Montanide ISA 51 in combination with chemotherapy (CDDP, 5-FU) plus
radiation therapy in treating patients with unresectable, advanced or recurrent esophageal
cancer.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety(toxicities as assessed by NCI CTCAE version3)
3 months
Yes
Kota Okinaga, MD, PhD
Study Chair
Teikyo University , Department Surgery
Japan: Ministry of Health, Labor and Welfare
TPR07-079
NCT00632333
February 2008
March 2012
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