Peptide Vaccine Targeting to Cancer Specific Antigen Combined With Anti-angiogenic Peptide Antigen in Treating Patients With Non-small Cell Lung Cancer

Fukushima Medical University

Status and phase: Completed; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Biological: HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2

Study type: Interventional

Funder types: Other

Identifiers

NCT00874588

FVT-L0901

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical response of different doses of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

Full description

URLC10 and CDCA1 have been identified as cancer specific molecules especially in non small cell lung cancer using genome-wide expression profile analysis by cDNA microarray technique. We have determined the HLA-A*2402 restricted epitope peptides derived from these molecules. We also tend to use the peptides targeting to tumor angiogenesis. VEGF receptor 1 and 2 are essential targets to tumor angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific CTL response in vitro and vivo. According to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides.

Enrollment: 6 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Disease characteristics

1. Advanced or recurrent non small cell lung cancer
2. Second line or later therapeutic status

Patient characteristics

1. ECOG performance status 0-2
2. Life expectancy > 3 months
3. HLA-A*2402
4. Laboratory values as follows 1500/mm3<WBC<15000/mm3 Platelet count>75000/mm3 Bilirubin < 3.0mg/dl Asparate transaminase < 99IU/L Alanine transaminase < 126IU/L Creatinine < 2.2mg/dl
5. Able and willing to give valid written informed consent

Exclusion criteria

1. Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
2. Pregnancy (woman of child bearing potential)
3. Active and uncontrolled infectious disease
4. Adrenal cortical steroid hormone dependent status
5. Decision of unsuitableness by principal investigator

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Phase I study

Experimental group

Treatment:

Biological: HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2