Multiple-Vaccine Therapy in Treating Patients With Non-small Cell Lung Cancer

Fukushima Medical University9 enrolled

Overview

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, TTK, VEGFR1 and VEGFR2 emulsified with Montanide ISA 51.

URLC10 and TTK 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non Small Cell Lung Cancer

Interventions

HLA-A*2402restricted URLC10, TTK, VEGFR1 and VEGFR2BIOLOGICAL

Escalating doses of every peptide will be administered by subcutaneous injection on days 1,8,15 and 22 of each 28-day treatment cycles. Planned doses of peptides are 0.5mg, 1.0mg and 3.0mg.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (1)

Fukushima Medical University Hospital

Fukushima, Fuskushima, Japan

Outcomes

Primary Outcomes

Adverse effects, dose limiting toxicity, and maximum tolerated dose as measured by CTCAE ver3.0 pre treatment, during study treatment, and 3 months after treatment

Time frame: 3 months

Secondary Outcomes

Peptides specific CTL responses in vitro

Time frame: 3 months

Objective response rate as assessed using RECIST criteria

Time frame: 6 months

Changes in levels of regulatory T cells

Time frame: 3 months

Data from ClinicalTrials.gov

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