Phase I Study of Multiple-Vaccine Therapy Including Antiangiogenic Vaccine Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer
20 Years
N/A
Both
Non Small Cell Lung Cancer
Trial Information
Phase I Study of Multiple-Vaccine Therapy Including Antiangiogenic Vaccine Using Epitope Peptide Restricted to HLA-A*2402 in Treating Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer
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.
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
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Outcome Time Frame:
3 months
Safety Issue:
Yes
Principal Investigator
Mitsukazu Gotoh, MD,PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Fukushima Medical University, First department of Surgery
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
FVT-L0701
NCT ID:
NCT00633724
Start Date:
May 2007
Completion Date:
May 2009
Related Keywords:
- Non Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
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