UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006927 |
|---|---|
| Receipt number | R000008175 |
| Scientific Title | Phase II Clinical trial of personalized peptide vaccine for cancer patients - Effect of extended dose interval on the immun induction - |
| Date of disclosure of the study information | 2011/12/21 |
| Last modified on | 2019/10/30 15:02:30 |
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Basic information
Public title
Phase II Clinical trial of personalized peptide vaccine for cancer patients - Effect of extended dose interval on the immun induction -
Acronym
Personalized peptide vaccine trial for cancer patients - Effect of extended dose interval on the immun induction -
Scientific Title
Phase II Clinical trial of personalized peptide vaccine for cancer patients - Effect of extended dose interval on the immun induction -
Scientific Title:Acronym
Personalized peptide vaccine trial for cancer patients - Effect of extended dose interval on the immun induction -
Region
| Japan |
Condition
Condition
malignant tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Chest surgery | Endocrine surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology | Oto-rhino-laryngology |
| Orthopedics | Urology | Radiology |
| Oral surgery | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to analyze the effect of extended dose intervals of the personalized peptide vaccination on the enhancement of peptide-specific IgG for patients with various malignant tumors from foreign countries or distant places.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Evaluation of immunological responses (anti-peptide IgG) before and after 3 dose vaccination.
Key secondary outcomes
Adverse effects and safety of peptide vaccination is evaluated based on the CTCAE Version 4.0 .
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
(1st course: total 3 doses with 21-28 day interval)
Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before the 1st vaccination, and s.c. inject to the patient.
If the patient hopes to continue the vaccine treatment after completion of Course 1 and the doctor accepts that, the treatment can be continued.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects must satisfy the following conditions.
1)Patients must be pathologically diagnosed as cancer,however,it is not necessary to possess target lesionns response evaluation.
2) Patients must be at a score level 0 of performance status (PS) (ECOG).
3) Patients must have IgG reactive to at least two of candidate peptides.
4)Patients must be expected to survive more than 3 months.
5) Patients must satisfy the followings:
WBC is more than 2,500/mm3
Lymphocyte is more than 1,000/mm3
Hb is more than 8.0g/dl
Platelet is more than 80,000/mm3
Serum Creatinine is less than 2 times upper limit of nomal.
Total Bilirubin is less than 2 times upper limit of nomal.
6) Patients must be more 20 year-old.
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3 super type.
Key exclusion criteria
The following patients must be excluded:
1) Patients with severe symptoms (active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation).
2) Patients with the past history of severe allergic reactions.
3) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation.
4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masanori Noguchi |
Organization
Kurume University
Division name
Research Center for Innovative Cancer Therapy
Zip code
Address
Asahi-machi 67, Kurume, Fukuoka 830-0011
TEL
0942-31-7572
noguchi@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Yamada |
Organization
Kurume University
Division name
Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
Zip code
Address
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7572
Homepage URL
akiymd@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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 12 | Month | 21 | 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
| 2011 | Year | 12 | Month | 09 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | 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
Other
Other related information
Management information
Registered date
| 2011 | Year | 12 | Month | 21 | Day |
Last modified on
| 2019 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008175
