UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029789 |
|---|---|
| Receipt number | R000034013 |
| Scientific Title | A phase II trial of personalized peptide vaccination for nine kinds of cancers |
| Date of disclosure of the study information | 2017/11/05 |
| Last modified on | 2019/12/06 13:20:24 |
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Basic information
Public title
A phase II trial of personalized peptide vaccination for nine kinds of cancers
Acronym
A phase II trial of peptide vaccination for nine kinds of cancers
Scientific Title
A phase II trial of personalized peptide vaccination for nine kinds of cancers
Scientific Title:Acronym
A phase II trial of peptide vaccination for nine kinds of cancers
Region
| Japan |
Condition
Condition
Prostate cancer, Urothelial cancer, Breast cancer, Lung cancer, Ovarian cancer, Gastric cancer, Colon cancer, Liver cancer, Pancreatic cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Breast surgery | Obstetrics and Gynecology |
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It became clear so far that an effect did not appear to the patient that an MCP-1 level was low in the blood and the peptide which was easy to appear of the clinical response existed from a clinical study result of the peptide vaccinotherapy that I gave. From these knowledge, I do a patient having low MCP-1 level out of the blood in the final examination with the adaptation outside and decide recommendation peptide and it is given priority with recommendation peptide and chooses peptide.
It is intended to weigh the immunoreactivity and a clinical response against conventional peptide vaccinotherapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Peptide-specific immune responses in PBMCs at the end of 1st course
Key secondary outcomes
Overall suvival
Adverse events of the entire period(safety assessments)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Vaccine |
Interventions/Control_1
For Prostate cancer,Urothelial cancer, Breast cancer, Lung cancer, Ovarian cancer, Gastric cancer, Colon cancer, Liver cancerand Pancreatic cancer patients I choose a maximum of four kinds as priority and give recommendation peptide subcutaneously from 31 kinds of vaccine candidate peptide.
The dose of the peptide assumes it 3 mg because of one peptide.
I give four times of dosage every week in dosage four times, every other week for the interdose interval and assume eight times in total 1 course. It is said that the dosage is possible continuously for patient hope after 2nd course.
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) A standard under treatment or treatment resistant malignant tumor and the Prostate cancer, Urothelial cancer, Breast cancer, Lung cancer, Ovarian cancer, Gastric cancer, Colon cancer, Liver cancer or Pancreatic cancer which is diagnosed.
2) Patients must be a score level 0 to 2 of ECOG performance status.
3) Patients must be expected to survive more than 3 months.
4) Patient's laboratory data must satisfy the followings
WBC > and = 2500/mm3
Lymphocyte > and = 900/mm3
Hb > and = 8.0g/dL
Platelet > and = 80000/mm3
Serum Creatinine = and < 2.0mg/dL
Serum total bilirubin = and < 2.5mg/dL
5) Plasma MCP 1 > and = 30pg/mL (ELISA method)
6) Patients must be more 18 years old
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA class IA (-A2, -A3, -A11, -A24, -A26, -A31 or -A33)
9) Distance opening more than at least 4 weeks when Nivolumab or Pembrolizumab was used as previous treatment
10) Patient must have IgGs reactive to at least 2 of candidate peptide restricted to the patient's HLA types. And at least one being recommendation peptides.
Key exclusion criteria
The following patients must be excluded
1) Patients with severe underlying diseases conditions (active and severe infection, circulatory diseases, respiratory diseases, renal diseases, immunodeficiencies, disturbance of coagulation,et al.)
2) Patients with the past history of severe allergic reactions.
3) Females Pregnant or nursing patients.
Males Patients who do not accept contraception during vaccination period and until 70 days after the last vaccination.
4) Patients who are judged inappropriate for entry to this clinical trial by examination medical attendant.
Target sample size
900
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
+81-942-27-5210
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
+81-942-27-5210
Homepage URL
http://www.med.kurume-u.ac.jp/med/cvc
yutani@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
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）、仙台厚生病院（宮城県）、内藤病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 05 | 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
| 2017 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 01 | 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=R000034013
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