NCT01069653

Safety Study of Peptide Cancer Vaccine To Treat HLA-A*24-positive Advanced Small Cell Lung Cancer

Phase I Study of Cancer Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*24 (CDCA1,KIF20A) in Patients With Small Cell Lung Cancer Refractory to Standard Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Shiga University · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*2402 restricted epitope peptides CDCA1 and KIF20A emulsified with Montanide ISA 51 for advanced small cell lung cancers.

Detailed description

The investigators previously identified three novel HLA-A\*2402-restricted epitope peptides, which were derived from two cancer-testis antigens, CDCA1 and KIF20A, as targets for cancer vaccination against lung cancer. In this phase I trial, the investigators examine using a combination of these two peptides the safety, immunogenicity, and antitumor effect of vaccine treatment for HLA-A\*2402-positive advanced small cell lung cancer patients who failed to standard therapy.

Conditions

• Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	HLA-A*2402-restricted CDCA1 and KIF20A peptides	Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.

Timeline

• Start date: 2010-02-01
• Primary completion: 2019-03-01
• Completion: 2019-03-01
• First posted: 2010-02-17
• Last updated: 2019-03-19

Locations

1 site across 1 country: Japan