Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Non-Small Cell Lung Cancer

Tokyo University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Non Small Cell Lung Cancer

Treatments: Biological: URLC10, TTK and KOC1

Study type: Interventional

Funder types: Other

Identifiers

NCT00674258

IMS-NSCLC24

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402 restricted epitope peptides URLC10, TTK and KOC1 emulsified with Montanide ISA 51.

Full description

URLC10,TTK and KOC1 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*2402 restricted epitope peptides derived from these molecules and identified that these peptides 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 URLC10-177 peptide(1mg), TTK-567 peptide(1mg) and KOC1-508 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.

Enrollment: 14 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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*2402

• Laboratory values as follows

  • 2000/mm3<WBC<15000/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
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

B

Experimental group

Treatment:

Biological: URLC10, TTK and KOC1