Know Cancer

or
forgot password

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)
Both
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,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.


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
- 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

Type of Study:

Interventional

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:

Yes

Principal Investigator

Naohide Yamashita, MD/PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Institute of Medical Science, The University of Tokyo

Authority:

Japan: Institutional Review Board

Study ID:

IMS-NSCLC24

NCT ID:

NCT00674258

Start Date:

May 2008

Completion Date:

April 2009

Related Keywords:

  • Non Small Cell Lung Cancer
  • HLA-A*2402
  • Peptide Vaccine
  • URLC10
  • TTK
  • KOC1
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location