UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000760 |
|---|---|
| Receipt number | R000000855 |
| Scientific Title | Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced pediatric malignant glioma patients |
| Date of disclosure of the study information | 2007/07/03 |
| Last modified on | 2011/09/28 10:40:46 |
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Basic information
Public title
Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced pediatric malignant glioma patients
Acronym
Pan-HLA type personalized peptide vaccine trial for pediatric malignant glioma patients
Scientific Title
Phase I clinical trial of pan-HLA type personalized peptide vaccine for advanced pediatric malignant glioma patients
Scientific Title:Acronym
Pan-HLA type personalized peptide vaccine trial for pediatric malignant glioma patients
Region
| Japan |
Condition
Condition
Advanced pediatric malignant glioma patients who are refractory to standard therapies
Classification by specialty
| Pediatrics | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to investigate adverse events (evaluation of safety) of pan-HLA type personalized peptide vaccine which applicable for almost all of cancer patients in Japanese and majority in the world. Pediatric patients(more 3 year-old and less 16 year-old), who are refractory to standard therapies for malignant glioma, will be enrolled. Peptides (maximum 4) among 24 (each 8 for HLA-A2, -A24, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered subcutaneously. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Adverse events of peptide vaccine are evaluated based on the CTCAE v3.0 (JCOG version).
Key secondary outcomes
Evaluation of immunological responses (cytotoxic T-lymphocytes , anti-peptide IgG) before and after vaccination.
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 24 (each 8 for HLA-A2, -A24, 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 (1 or 2 mg/peptide) are separately injected into subcutaneous once a week for 6-weeks (total 6 times). Brain CT/MRI, and blood samples for hematology and biochemistry are taken at beginning and 1-week after the 6th 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
| 3 | years-old | <= |
Age-upper limit
| 20 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subjects must satisfy the following conditions.
1) Patients must be clinically diagnosed as malignant glioma, and are refractory to standard therapies such as radiotherapy or radiochemotherapy.
2) Patients must be more 3 year-old and less 16 year-old.
3) Patients must be positive for HLA-A2, -A3, -A11, -A24, -A31, or -A33.
4) Patients must have significant level of plasma IgG reactive to at least one of the vaccine candidate peptides.
5) The vaccine therapy must be started more than 4 weeks after the last chemotherapy.
6) Patients must be expected to survive more than 3 months.
7) Patients must satisfy the followings:
WBC more than 3,000/mm3
Lymphocytes more than 1,000/mm3
Hb more than 10.0g/dl
Platelet more than 100,000/mm3
Serum Creatinine less than 1.5 times of the standard value
Total Bilirubin less than 1.5 times of the standard value
ALT less than 2.5 times of the standard value
AST less than 2.5 times of the standard value
9) Written informed consent must be obtained from patients and legally acceptable representatives.
10) Patients must be negative for Hepatitis virus B/C.
Key exclusion criteria
The following patients must be excluded:
1) Patients with cerebral or cerebellar grade I or II glioma. 2) Patients with severe symptoms (circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc).
3) Patients with the past history of severe allergic reactions.
4) Patients with active infectious disease
5) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation.
6) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Minoru Shigemori |
Organization
Kurume University School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
Asahi-machi 67, Kurume,Fukuoka 830-0011, Japan
TEL
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
TEL
0942-31-7744
Homepage URL
http://www.med.kurume-u.ac.jp/med/sentanca/examine.html
akiynd@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of Immunology, Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization
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
| 2007 | Year | 07 | Month | 03 | 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
| 2007 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | 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
| 2007 | Year | 07 | Month | 03 | Day |
Last modified on
| 2011 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000855
