UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015173 |
|---|---|
| Receipt number | R000017518 |
| Scientific Title | A randomised phase II trial of personalized peptide vaccination plus "Keppuchikuoto" vs personalized peptide vaccination alone for non small cell lung cancer patients |
| Date of disclosure of the study information | 2014/09/26 |
| Last modified on | 2017/04/06 14:36:35 |
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Basic information
Public title
A randomised phase II trial of personalized peptide vaccination plus "Keppuchikuoto" vs personalized peptide vaccination alone for non small cell lung cancer patients
Acronym
A randomised phase II trial of peptide vaccination with "keppuchikuoto" for non samll cell lung cancer patients
Scientific Title
A randomised phase II trial of personalized peptide vaccination plus "Keppuchikuoto" vs personalized peptide vaccination alone for non small cell lung cancer patients
Scientific Title:Acronym
A randomised phase II trial of peptide vaccination with "keppuchikuoto" for non samll cell lung cancer patients
Region
| Japan | Asia(except Japan) |
Condition
Condition
Unresectable non smaii cell lung cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the immunological responses and overall survival of personalized peptide vaccination plus Keppuchikuoto with personalized peptide vaccination alone.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Assesment of immunoresponses by mesurement of peptide specific CTL responses by ELISPOT assay
Key secondary outcomes
1.Assesment of immunoresponses by mesurement of peptide specific IgGs
2.Overall survival
3.Safety assesment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
Peptide vaccine plus Keppuchikuoto
Interventions/Control_2
Peptide vaccine
Interventions/Control_3
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects must satisfy the following conditions.
1) Cytologically or histologically documented non-small cell carcinoma of the lung that is not for curable therapy.
2) Patients must be at a score level 0-1 of ECOG performance status.
3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types.
4) Patients must be positive for HLA-A2,A24,A26,A3,A11,A31 or A33.
5) Patients must be expected to survive more than 3 months.
6) Ptient's laboratory data must satisgy the followings:
WBC is more than 2500/mm3
Lymphocyte is more than 900/mm3
Hb is more than 8.0g/dL
Platelet is more than 80000/mm3
Serum Creatinine is less than 2 times the ULN
Total bilirubin is less than 2 times the ULN
7) Patients must be more 18 year-old
8) Written informed consent must be obtained from patients.
Key exclusion criteria
The following patients must be excluded:
1) Patients with severe underlying diseases / conditions(active and severe infectious diseases, circulatory diseases, respiratory diseases, renal diseases, immunodeficiencies, disturbance of coagulation, et al. Respiratory diseases are pulmonary damage, such as interstitial pneumonia and pneumoconiosis).
2) Active double cancer(synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ(lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
3) Patients with the past history of severe allergic reactions.
4) (Females)Pregnant or nursing patients.
Patients desiring future fertility.
(Males)Patients who do not sccept contraception from the 1st vaccination until 70 days after the last vaccination.
5) Patients who has taken Keppuchikuoto.
6) Patients who has taken Bevacizumab.(Participation is made possible when four or more weeks have passed from the last medication to an examination opening day.)
7) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigeru Yutani |
Organization
Kurume University
Division name
Cancer Vaccine Center
Zip code
Address
155-1 Kokubu-machi Kurume-city Fukuoka-pref JAPAN, 839-0863
TEL
0942-27-5210
yutani@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeru Yutani |
Organization
Kurume University
Division name
Cancer Vaccine Center
Zip code
Address
155-1 Kokubu-machi Kurume-city Fukuoka-pref JAPAN, 839-0863
TEL
0942-27-5210
Homepage URL
http://www.med.kurume-u.ac.jp/med/cvc/
yutani@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume Unversity Cancer Vaccine Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
久留米大学がんワクチンセンター（福岡県）、内藤病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 26 | 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
| 2014 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 16 | Day |
Last modified on
| 2017 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017518
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