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

Phase 1

Completed

• Conditions: Small Cell Lung Cancer
• Interventions: Biological: HLA-A*2402-restricted CDCA1 and KIF20A peptides

• Registration Number: NCT01069653
• 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\*2402 restricted epitope peptides CDCA1 and KIF20A emulsified with Montanide ISA 51 for advanced small cell lung cancers.

Detailed Description

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CDCA1-KIF20A-1mg	HLA-A*2402-restricted CDCA1 and KIF20A peptides	Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A\*2402-restricted CDCA1 peptide (1mg) and KIF20A peptide(1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
CDCA1-KIF20A-3mg	HLA-A*2402-restricted CDCA1 and KIF20A peptides	Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A\*2402-restricted CDCA1 peptide (3mg) and KIF20A peptide(3mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
CDCA1-KIF20A-2mg	HLA-A*2402-restricted CDCA1 and KIF20A peptides	Patients will be vaccinated once a week for four weeks of a treatment cycle. On each vaccination day, the HLA-A\*2402-restricted CDCA1 peptide (2mg) and KIF20A peptide(2mg) 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
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)
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)

Trial Locations

Locations (1)

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