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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002141
Receipt No. R000002614
Scientific Title Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy.
Date of disclosure of the study information 2009/07/01
Last modified on 2014/07/17

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Basic information
Public title Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy.
Acronym Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy.
Scientific Title Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy.
Scientific Title:Acronym Phase I study of Multiple-Vaccine Therapy in Patient with Refractory Non-Small-Cell Lung Cancer to Chemotherapy.
Region
Japan

Condition
Condition Non-Small-Cell Lung Cancer
Classification by specialty
Pneumology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate safety and adverse effect on cancer vaccination therapy using tumor-associated antigen URLC1 and CDCA1 peptide in patient with refractory Non-small-cell lung cancer to chemotherapy.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes Evaluation of safety and adverse effects of vaccination therapy and determination of the recommended dose for phase II trial
Key secondary outcomes

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
Vaccine
Interventions/Control_1 Both URLC10 and CDCA1 peptides restricted to HLA-A*2402 (0.5mg for each) are administered four times once a week.
Interventions/Control_2 Both URLC10 and CDCA1 peptides restricted to HLA-A*2402 (1.0mg for each) are administered four times once a week.
Interventions/Control_3 Both URLC10 and CDCA1 peptides restricted to HLA-A*2402 (3.0mg for each) are administered four times once a week.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically and/or cytologically proven NSCLC, which is refractory to any chemotherapy.
2.ECOG performance status 0-2
3.No severe postoperative complications
4.Age between 20 to 80
5.3000/mm3<WBC<15000/mm3
Hemoglobin>8.0g/dl
Platelet count>75000/mm3
Asparate transaminase < 150IU/L
Alanine transaminase < 150IU/L
Total bilirubin < 3.0mg/dl
PaO2 > 60 torr
Serum creatinine < 2.0mg/dl
6.Life expectancy > 3 months
7.HLA-A*2402
8.Able and willing to give valid written informed consent
Key exclusion criteria 1.Pregnancy
2.Breastfeeding
3.Concurrent treatment with steroids or immunosuppressing agent
4.No other malignancy requiring treatment
5.No curative traumatic wound
6.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 Kazuhisa Takahashi
Organization Juntendo University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 2-1-1 Hongo, Bunkyo-Ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Respiratory Medicine, Juntendo University School of Medicine
Institute
Department

Funding Source
Organization Juntendo University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 01 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 Terminated
Date of protocol fixation
2009 Year 06 Month 05 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2015 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 06 Month 30 Day
Last modified on
2014 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002614

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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