UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011593 |
|---|---|
| Receipt number | R000013556 |
| Scientific Title | Phase II clinical trial of combination of personalized peptide vaccination, Cyclophosphamide and Imiquimod for advanced Pancreatic cancer patients who failed standard therapy. |
| Date of disclosure of the study information | 2013/08/28 |
| Last modified on | 2017/11/10 15:42:54 |
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Basic information
Public title
Phase II clinical trial of combination of personalized peptide vaccination, Cyclophosphamide and Imiquimod for advanced Pancreatic cancer patients who failed standard therapy.
Acronym
Phase II study of peptide vaccination for advanced Pancreatic cancer patients.
Scientific Title
Phase II clinical trial of combination of personalized peptide vaccination, Cyclophosphamide and Imiquimod for advanced Pancreatic cancer patients who failed standard therapy.
Scientific Title:Acronym
Phase II study of peptide vaccination for advanced Pancreatic cancer patients.
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to investigate immunity-enhancing, safety and clinical effect of combination of personalized peprtide vaccine, Cyclophosphamide and Imiquimod for advanced Pancreatic cancer patients who failed satanderd therapy using randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Comparison between two groups of immune-enhancing effects.
Key secondary outcomes
1.Comparison between two groups of advere, safety of peptide vaccination
2.Comparison between two groups of long-term prognosis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
On administration day of the peptide vaccine,applicate Imiquimod(liniment cream) to the injection area, and wash away after 8 hours.
Select vaccine peptides(up to 4)from 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination.
Individually emulsify these peptides (3.0mg/peptide)with adjuvant and subcutaneously inject.(Total 8 times, every 1week 4 times and every two weeks 4 times)
Before 7 days to the pevious day from administration of the peptide vaccine, by mouth twice a day Cyclophosphamide. The amount of oral once 50mg.
Interventions/Control_2
Select vaccine peptides(up to 4)from 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination.
Individually emulsify these peptides(3.0mg/peptide) with adjuvant and subcutaneously inject.(Total 8 times, every 1week 4 times and every two weeks 4 times)
Before 7 days to the pevious day from administration of the peptide vaccine, by mouth twice a day Cyclophosphamide. The amount of oral once 50mg.
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)Parients must be diagnosed as Pancreatic cancer of the standard cancer of the standard therapy failed.
2)Patients must be at a score level 0 or 1 of ECOG performance status.
3)Patients must have igGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types.
4)Ptients must be expected to survive more than 3 months.
5)Patients must satisfy 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 50000/mm3
Serum Creatinine is less than 2.0mg/dl
Total Bilirubin is less than 2.5mg/dl
6)Patients must be more 18 year-old.
7)Written informed consent must be obtained from patients.
8)Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.
Key exclusion criteria
The following patients must be excluded:
1)Patients with severe symptoms(active and severe infectious disease, circulatory disease, respiratory dusease, kidney disease, immunodeficuency, disease of coagulation.
2)Patients with the past history pf severe allergic reactions.
3)(Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility.
(Males) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination.
4)Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
66
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
Kokubu-machi 155-1, Kurume, Fukuoka 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
Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL
0942-27-5210
Homepage URL
http://www.med.kurume-u.ac.jp/med/cvc/F/
yutani@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University Cancer Vaccine Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
久留米大学医療センター
久留米大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 28 | 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
| 2013 | Year | 06 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 27 | Day |
Last modified on
| 2017 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013556
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