Safety Study of Peptide Cancer Vaccine To Treat HLA-A*02-positive Advanced Non-small Cell Lung Cancer

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer
• Interventions: Biological: HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides

• Registration Number: NCT01069640
• Lead Sponsor: Shiga University

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, immune response and clinical efficacies of HLA-A\*0201 or HLA-A\*0206 restricted epitope peptides URLC10 emulsified with Montanide ISA 51 for advanced non-small cell lung cancers.

Detailed Description

The investigators previously identified three novel HLA-A\*0201 or HLA-A\*0206-restricted epitope peptides, which were derived from a cancer-testis antigen, URLC10, 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 HHLA-A\*0201 or HLA-A\*0206-positive advanced non-small cell lung cancer patients who failed to standard therapy.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-16
• Study First Submitted QC: 2010-02-16
• Study First Posted: 2010-02-17
• Status Verified: 2019-03
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Last Update Submitted: 2019-03-15
• Last Update Posted: 2019-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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*0201 or HLA-A*0206
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
URLC10-2mg	HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides	Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A\*0201 or HLA-A\*0206-restricted URLC10 peptide (2mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
URLC10-3mg	HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides	Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A\*0201 or HLA-A\*0206-restricted URLC10 peptide (3mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
URLC10-1mg	HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides	Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A\*0201 or HLA-A\*0206-restricted URLC10 peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.

Primary Outcome Measures

Name	Time	Method
Evaluation of tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) for the determination of the recommended dose for next phase trial.	2 months
Evaluation of safety (NCI CTCAE version3): the number of adverse events of vaccination therapy.	2 months

Secondary Outcome Measures

Name	Time	Method
Evaluation of clinical efficacy: Objective response rate (RECIST1.1), Tumor markers, Overall survival, Progression free survival.	2 months (every time point(s) at which each course is completed)
Immunological responses: Peptides specific CTL, Antigen cascade, Regulatory T cells, Cancer antigens and HLA levels.	2 months (every time point(s) at which each course is completed)

Trial Locations

Locations (1)

Shiga University of Medical Science Hospital; 🇯🇵 Otsu, Shiga, Japan