Dataset Information

Phase I clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer.

ABSTRACT:

Background

The prognosis of patients with advanced biliary tract cancer (BTC) is extremely poor and only a few standard treatments are available for this condition. We performed a phase I trial to investigate the safety, immune response and anti-tumor effect of vaccination with three peptides derived from cancer-testis antigens.

Methods

This study was conducted as a phase I trial. Nine patients with advanced BTC who had unresectable tumors and were refractory to standard chemotherapy were enrolled. Three HLA-A*2402 restricted epitope peptides-cell division cycle associated 1 (CDCA1), cadherin 3 (CDH3) and kinesin family member 20A (KIF20A)-were administered subcutaneously, and the adverse events and immune response were assessed. The clinical effects observed were the tumor response, progression-free survival (PFS) and overall survival (OS).

Results

The three-peptide vaccination was well-tolerated up to a dose of 3 mg per peptide (9 mg total). No grade 3 or 4 adverse events were observed after vaccination. Peptide-specific T cell immune responses were observed in all patients and stable disease was observed in 5 of 9 patients. The median PFS and OS were 3.4 and 9.7 months. The Grade 2 injection site reaction and continuous vaccination after PD judgment appeared to be prognostic of OS.

Conclusions

Multiple-peptide vaccination was well tolerated and induced peptide-specific T-cell responses.

Trial registration

This study was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR000003229).

SUBMITTER: Aruga A

PROVIDER: S-EPMC4015445 | biostudies-literature | 2014 Mar

REPOSITORIES: biostudies-literature

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Publications

Phase I clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer.

Aruga Atsushi A Takeshita Nobuhiro N Kotera Yoshihito Y Okuyama Ryuji R Matsushita Norimasa N Ohta Takehiro T Takeda Kazuyoshi K Yamamoto Masakazu M

Journal of translational medicine 20140307

<h4>Background</h4>The prognosis of patients with advanced biliary tract cancer (BTC) is extremely poor and only a few standard treatments are available for this condition. We performed a phase I trial to investigate the safety, immune response and anti-tumor effect of vaccination with three peptides derived from cancer-testis antigens.<h4>Methods</h4>This study was conducted as a phase I trial. Nine patients with advanced BTC who had unresectable tumors and were refractory to standard chemother ...[more]

PMID: 24606884

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Dataset Information

Phase I clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer.

Background

Methods

Results

Conclusions

Trial registration

Publications

Phase I clinical trial of multiple-peptide vaccination for patients with advanced biliary tract cancer.

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