UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001482 |
|---|---|
| Receipt number | R000001740 |
| Scientific Title | Phase II Clinical trial of personalized peptide vaccine for cancer patients |
| Date of disclosure of the study information | 2008/11/05 |
| Last modified on | 2019/12/06 13:23:19 |
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Basic information
Public title
Phase II Clinical trial of personalized peptide vaccine for cancer patients
Acronym
Personalized peptide vaccine trial for cancer patients
Scientific Title
Phase II Clinical trial of personalized peptide vaccine for cancer patients
Scientific Title:Acronym
Personalized peptide vaccine trial for cancer patients
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
This clinical trial is the personalized peptide vaccination for cancer patients. Peptides, identifed as vaccine candidates for cancer patients,which is recognized by patient's serum are administered subcutaneously.
The aim of this study is to investigate the enhancement of peptide specific antibody in vaccinated patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Evaluation of the peptide specific antibody before and after vaccination.
Key secondary outcomes
Analyze the correlation between enhancemt of peptide specific antibody and all over survival. Adverse events of peptide vaccination are evaluated based on the CTCAE v3.0 (JCOG).
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
Peptides (maximum 4) among 27 (for HLA-A2, -A24, -A26, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered with Freund incomplete adjuvant. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides.
Each emulsified peptide (3 mg/peptide) are separately injected into subcutaneous once a week for 6-weeks (total 6 times). Blood samples for hematology and biochemistry are taken the beginning of vaccination.
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 lesions for response evaluation.
2)Patients must be at a score level of 0-2 of performance status (PS) (ECOG). Exceptionally, PS3 patients only in neurological symptom can be enrolled.
3)Patients must have significant level of plasma IgG reactive to at least two of the vaccine candidate peptides.
4) Patients must be expected to survive more than 3 months.
5) Patients must satisfy the followings:
WBC more than 2,500/mm3
Lymphocytes more than 1,000/mm3
Hb more than 8.0g/dl
Platelet more than 80,000/mm3
Serum Creatinine less than 2x normal upper limit
Total Bilirubin less than 2x normal upper limit
6)Patients must be more than 20 year-old.
7)Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2, -A3, -A11, -A24, -A26, -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 disease, kidney disease, immunodeficiency, disturbance of coagulation etc).
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
150
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
0942-31-7989
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 Department Division
Zip code
Address
Asahimachi 67, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7551
Homepage URL
http://www.med.kurume-u.ac.jp/med/immun/F/
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
Sendi public welfare hospital
Name of secondary funder(s)
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
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
仙台厚生病院（宮城県）Sendi public welfare hospital
Other administrative information
Date of disclosure of the study information
| 2008 | 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
| 2008 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2008 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 11 | Month | 05 | 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=R000001740
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