UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019390 |
|---|---|
| Receipt number | 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 13:19:10 |
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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 | Obstetrics 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
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 University 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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022423
