UMIN-CTR Clinical Trial

Basic information
Public title	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 I study)
Acronym	Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A*24 (URLC10,CDCA1,KIF20A) in Patients with Refractory Non-small Cell Lung Cancer
Scientific Title	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 I study)
Scientific Title:Acronym	Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A*24 (URLC10,CDCA1,KIF20A) in Patients with Refractory Non-small Cell Lung Cancer
Region	Japan

Condition
Condition	Non-small Cell Lung Cancer
Classification by specialty	Pneumology Hematology and clinical oncology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the safety, tolerability, adverse effects, immune response and clinical efficacy of different doses of HLA-A*2402 restricted epitope peptides (URLC10, CDCA1, and KIF20A) in treating patients with non-small cell lung cancer refractory to standard therapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	Evaluation of safety and tolerability (maximum tolerated dose, MTD and dose limiting toxicity, DLT) as well as adverse effects of vaccination therapy, and determination of the recommended dose for next phase trial.
Key secondary outcomes	1.Evaluation of immunological responses Peptides specific CTL responses in vitro Antigen cascade Changes in levels of regulatory T cells Expression of cancer antigens and HLA 2.Evaluation of clinical efficacy Objective response rate (by RECIST) Monitoring of tumor markers Overall survival Progression free survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	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.
Interventions/Control_2	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.
Interventions/Control_3	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.
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key 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
Key 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
Target sample size	18

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Yataro Daigo
Organization	Shiga University of Medical Science
Division name	Department of Medical Oncology
Zip code
Address	Tsukinowa-cho, Otsu, Shiga 520-2192, Japan
TEL
Email

Public contact
1st name of contact person	1st name Middle name Last name
Organization	Shiga University of Medical Science
Division name	Department of Medical Oncology
Zip code
Address	Tsukinowa-cho, Otsu, Shiga 520-2192, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Human Genome Center, Institute of Medical Science, The University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01069575
Org. issuing International ID_1	U.S. National Institutes of Health (ClinicalTrials.gov)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	滋賀医科大学医学部附属病院（滋賀県）

Other administrative information
Date of disclosure of the study information	2010 Year 02 Month 16 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 10 Month 29 Day
Date of IRB	2009 Year 10 Month 29 Day
Anticipated trial start date	2010 Year 02 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2010 Year 02 Month 16 Day
Last modified on	2019 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003649