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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019390
Receipt No. R000022423
Scientific Title A phase II trial of personalized peptide vaccination for several cancer patients with slight bone marrow suppression
Date of disclosure of the study information 2015/10/19
Last modified on 2019/12/06

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Basic information
Public title A phase II trial of personalized peptide vaccination for several cancer patients with slight bone marrow suppression
Acronym A phase II trial of peptide vaccination for several cancer patients with slight bone marrow suppression
Scientific Title A phase II trial of personalized peptide vaccination for several cancer patients with slight bone marrow suppression
Scientific Title:Acronym A phase II trial of peptide vaccination for several cancer patients with slight bone marrow suppression
Region
Japan

Condition
Condition Cancer patients who are under standard treatments or resistant to standard treatments with slight bone marrow suppression
Classification by specialty
Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Pneumology Hematology and clinical oncology Nephrology
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery Breast surgery Obsterics and gynecology
Dermatology Oto-rhino-laryngology Orthopedics
Urology Oral surgery Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to investigate the immunological responses of personalized peptide vaccination for several cancer patients who are under standard treatments or resistant to standard treatments with slight bone marrow suppression
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Assessment of immunoresponses by mesurement of peptide specific IgGs
Key secondary outcomes 1.Safety assessment
2.Overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 4 peptide vaccines are selected from 31 peptide restrcted by HLA-class I based on higher peptide-specific IgG responses before vaccination.
Selected peptides are separately and subcutaneously injected (3.0mg/peptide) every 1 week interval for 6 times.
Interventions/Control_2
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)Patients who are during or resistant to standard treatment of Prostate, Urothelium, Kidney, Brain, Head and Neck, Lung, Esophagus, Stomach, Liver, Biliary tract, Pancreas, Colon, Ovary, Uterus, Breast, Sarcoma, Hematapostema, Skin, Primary unknown cancer and Rare cancer.
2)Patients must be at a score level of 0-2 of performance status(PS)(ECOG).
3)Patients must have IgGs reactive to at least 2 peptides from 31 candidate peptides restricted to the patient's HLA types.
4)Patients must be expected to survive more than 3 months.
5)Patient's laboratory data must satisfy the followings:
WBC > and = 2000/mm3
Lymphocyte 500-900/mm3
Hb > and = 8.0 g/dL
Platelet > and = 50000/mm3
Serum Creatinine < and = 2.0mg/dL
Serum Total Bilirubin < and = 2.5mg/dL
6)Patients must be more 18 years-old.
7)Written informed consent must be obtained from patients.
8)Patients must be positive for HLA-A2,A24,A26,A3,A11,A31,A33

Key exclusion criteria The following patients must be excluded.
1)Patients with severe underlying diseases/ conditions(active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc.)
2)Patients with the past history of severe allergic reactions.
3)(Females) Pregnant or nursing patients. Patients desiring future fertility.
(Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination.
4)Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size 1000

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
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 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/
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 Self funding
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
2015 Year 10 Month 19 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
2015 Year 10 Month 16 Day
Date of IRB
2015 Year 10 Month 16 Day
Anticipated trial start date
2015 Year 10 Month 19 Day
Last follow-up date
2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 10 Month 17 Day
Last modified on
2019 Year 12 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022423

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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