Phase I Trial in Studying Peptide Vaccine Therapy Targeting to Cancer Specific Antigen Combined With Anti-angiogenic Peptide Antigen in Treating Patients With Advanced or Recurrent Non-small Cell Lung Cancer
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Fukushima Medical University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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\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
- •Active and uncontrolled cardiac disease (includes patients with myocardial infarction within 6 months before entry)
- •Pregnancy (woman of child bearing potential)
- •Active and uncontrolled infectious disease
- •Adrenal cortical steroid hormone dependent status
- •Decision of unsuitableness by principal investigator
Arms & Interventions
Phase I study
Intervention: HLA-A*2402restricted URLC10, CDCA1, VEGFR1 and VEGFR2 (Biological)
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(3 months)
- Objective response rate as assessed using RECIST criteria(6 months)
- Changes in levels of regulatory T cells(3 months)
Investigators
Hiroyuki Suzuki
Professor
Fukushima Medical University