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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011593
Receipt No. 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

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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
Email 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/
Email yutani@med.kurume-u.ac.jp

Sponsor
Institute Kurume University Cancer Vaccine Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013556

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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