Safety Study of Peptide Cancer Vaccine To Treat HLA-A*24-positive Advanced Non-small Cell Lung Cancer

Shiga University

Status and phase: Completed; Phase 1

Conditions: Non-Small Cell Lung Cancer

Treatments: Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides

Study type: Interventional

Funder types: Other

Identifiers

NCT01069575

SUMS-21-72

UMIN000003189 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A*2402 restricted epitope peptides URLC10, CDCA1, and KIF20A emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.

Full description

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

URLC10-CDCA1-KIF20A 1mg

Experimental group

Description:

Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A\*2402-restricted URLC10 peptide (1mg), CDCA1 peptide (1mg) and KIF20A peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Treatment:

Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides

URLC10-CDCA1-KIF20A 2mg

Experimental group

Description:

Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A\*2402-restricted URLC10 peptide (2mg), CDCA1 peptide (2mg) and KIF20A peptide(2mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Treatment:

Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides

URLC10-CDCA1-KIF20A 3mg

Experimental group

Description:

Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A\*2402-restricted URLC10 peptide (3mg), CDCA1 peptide (3mg) and KIF20A peptide(3mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Treatment:

Biological: HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides