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Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Non-Small Cell Lung Cancer

Phase 1/Phase 2
20 Years
85 Years
Open (Enrolling)
Non Small Cell Lung Cancer

Thank you

Trial Information

Phase I/II Study of Multiple-Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*0201 in Treating Patients With Refractory Non-Small Cell Lung Cancer

URLC10 has 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*0201 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. Patients will be vaccinated twice a week for 8 weeks.
On each vaccination day, the URLC10-117 peptide(1mg), VEGFR1 peptide(1mg) and VEGFR2
peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Repeated cycles of vaccine will be administered until patients develop progressive disease
or unacceptable toxicity, whichever occurs first. In the phase I study, we evaluate the
safety and tolerability of these peptide vaccine. In the following phase II study, we
evaluate the immunological and clinical response of this vaccine therapy.

Inclusion Criteria:

Disease characteristics

- Advanced or recurrent non small cell lung cancer

- Second line or later therapeutic status Patient characteristics

- ECOG performance status 0-2

- Life expectancy > 3 months

- HLA-A*0201

- Laboratory values as follows

- 2000/mm3
- Platelet count>100000/mm3

- Bilirubin < 3.0mg/dl

- Asparate transaminase < 150IU/L

- Alanine transaminase < 150IU/L

- Creatinine < 3.0mg/dl

- Able and willing to give valid written informed consent

Exclusion Criteria:

- Pregnancy(woman of childbearing potential:Refusal or inability to use effective means
of contraception)

- Breastfeeding

- Active or uncontrolled infection

- Unhealed external wound

- Concurrent treatment with steroids or immunosuppressing agent

- Prior chemotherapy,radiation therapy, or immunotherapy within 4 weeks

- Uncontrolled brain and/or intraspinal metastasis

- Decision of unsuitableness by principal investigator or physician-in-charge

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

safety(Phase I:toxicities as assessed by NCI CTCAE version3) and efficacy(Phase II:Feasibility as evaluated by RECIST)

Outcome Time Frame:

two months

Safety Issue:


Principal Investigator

Naohida Yamashita, MD/PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Institute of Medical Science, The University of Tokyo


Japan: Institutional Review Board

Study ID:




Start Date:

May 2008

Completion Date:

April 2009

Related Keywords:

  • Non Small Cell Lung Cancer
  • HLA-A*0201
  • Peptide Vaccine
  • URLC10
  • VEGFR1
  • VEGFR2
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms