UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002141 |
|---|---|
| Receipt number | 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 10:28:54 |
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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
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
Sponsor or person
Institute
Department of Respiratory Medicine, Juntendo University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002614
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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