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Phase I Study of Cancer Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*24 (URLC10,CDCA1,KIF20A) in Patients With Non-small Cell Lung Cancer Refractory to Standard Therapy


Phase 1
20 Years
85 Years
Open (Enrolling)
Both
Non-Small Cell Lung Cancer

Thank you

Trial Information

Phase I Study of Cancer Vaccine Therapy Using Epitope Peptide Restricted to HLA-A*24 (URLC10,CDCA1,KIF20A) in Patients With Non-small Cell Lung Cancer Refractory to Standard Therapy


The investigators previously identified three novel HLA-A*2402-restricted epitope peptides,
which were derived from three cancer-testis antigens, URLC10, CDCA1, and KIF20A, as targets
for cancer vaccination against lung cancer. In this phase I trial, the investigators examine
using a combination of these three peptides the safety, immunogenicity, and antitumor effect
of vaccine treatment for HLA-A*2402-positive advanced non-small cell lung cancer patients
who failed to standard therapy.


Inclusion Criteria:



1. NSCLC that can not undergo curative surgery and treatment, and is refractory to
standard chemotherapy and radiotherapy

2. ECOG performance status 0-2

3. Age between 20 to 85

4. Clinical efficacy can be evaluated by some methods

5. No prior chemotherapy, radiation therapy, hyperthermia or immunotherapy within 4
weeks

6. Life expectancy > 3 months

7. Laboratory values as follows 1500/mm3 < WBC < 15000/mm3 Platelet count > 75000/mm3
Asparate transaminase < 3 X cutoff value Alanine transaminase < 3 X cutoff value
Total bilirubin < 3 X cutoff value Serum creatinine < 2X cutoff value

8. HLA-A*2402

9. Able and willing to give valid written informed consent

Exclusion Criteria:

1. Active and uncontrolled cardiac disease (i.e. coronary syndromes, arrhythmia)

2. Myocardial infarction within six months before entry

3. Breastfeeding and Pregnancy (woman of child bearing potential)

4. Active and uncontrolled infectious disease

5. Concurrent treatment with steroids or immunosuppressing agent

6. Other malignancy requiring treatment

7. Non-cured traumatic wound

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy.

Outcome Time Frame:

2 months

Safety Issue:

Yes

Principal Investigator

Yataro Daigo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Medical Oncology, Shiga University of Medical Science

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

SUMS-21-72

NCT ID:

NCT01069575

Start Date:

February 2010

Completion Date:

October 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • URLC10
  • CDCA1
  • KIF20A
  • lung cancer
  • vaccine
  • HLA-A*2402
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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