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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003191
Receipt No. R000003652
Scientific Title Cancer Vaccine Therapy using Epitope Peptide Restricted to HLA-A*24 (CDCA1,KIF20A) in Patients with Small Cell Lung Cancer Refractory to Standard Therapy (Phase I study).
Date of disclosure of the study information 2010/02/16
Last modified on 2019/03/31

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

Condition
Condition 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 (CDCA1 and KIF20A) in treating patients with 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 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 CDCA1 peptide (2mg) and KIF20A peptide(1mg) 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 CDCA1 peptide (3mg) and KIF20A peptide(1mg) 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. 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
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 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yataro Daigo MD, PhD
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
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 NCT01069653
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=R000003652

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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