UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010068 |
|---|---|
| Receipt number | R000011787 |
| Scientific Title | Phase II Clinical trial of personalized peptide vaccine for patients with various types of cancers - Effect of sequencial change of vaccine antigens - |
| Date of disclosure of the study information | 2013/03/01 |
| Last modified on | 2019/12/06 14:53:34 |
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Basic information
Public title
Phase II Clinical trial of personalized peptide vaccine for patients with various types of cancers - Effect of sequencial change of vaccine antigens -
Acronym
Personalized peptide vaccine trial for cancer patients -Effect of sequencial change of vaccine antigens -
Scientific Title
Phase II Clinical trial of personalized peptide vaccine for patients with various types of cancers - Effect of sequencial change of vaccine antigens -
Scientific Title:Acronym
Personalized peptide vaccine trial for cancer patients -Effect of sequencial change of vaccine antigens -
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 effects of sequencial change of vaccine antigens with anti-peptide IgG in each cycle (6 vaccinations) of the personalized peptide vaccination on the clinical effects and the peptide-specific imune responses in patients after 2 cycles (12 times) of vaccinations.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Evaluation of antigen-specific immune responses after 12 and 18 times of vaccinations.
Key secondary outcomes
1. Adverse effects and safety of personalized peptide vaccination are evaluated based on the CTCAE Version 4.0
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
For patients with HLA-A2, -A24, -A26, or -A3 supertype, HLA-matched vaccine peptides (maximum 4 peptides) with anti-peptide IgG in plasma are administered with Freund incomplete adjuvant. Each peptide (3 mg/peptide) are subcutaneously injected at separate sites once a week at the first cycle of 6 vaccinations and every 2-4 weeks at the second cycle of 6 vaccinations or at the third cycle of 6 vaccinations. The patients can receive more cycles of vaccinations, if the situation allows. Selection of vaccine peptides for each patient is performed according to the plasma IgG titers to the candidate peptides. At the first cycle, HLA-matched vaccine peptides (maximum 4 peptides) with higher IgG titers are selected. At the second cycle, another combination of HLA-matched vaccine peptides (maximum 4 peptides) with higher IgG titers, which have not been employed before, is selected. At the third cycle, another combination of HLA-matched vaccine peptides (maximum 4 peptides) with higher IgG titers, which have not been employed before, is selected.
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,they do not need to possess target lesions for response evaluation.
2) Patients must be at the performance status(PS) score levels of 0 to 2 (ECOG). Exceptionally, PS3 patients only in neurological symptom can be enrolled.
3) Patients must have IgG reactive to at least two of HLA-matched candidate peptides in plasma.
4) Patients must be expected to survive more than 3 months.
5) Patients must satisfy the followings:
WBC number is more than 2,500/mm3
Lymphocyte number is more than 1,000/mm3 Hb is more than 8.0g/dl
Platelet number is more than 80,000/mm3. Exceptionally, platelet number is more than 50,000/mm3 in lirer cancer
Serum creatinine is less than 2 times of upper limit of nomal.
Total bilirubin is less than 2 times of upper limit of nomal.
6) Patients must be more than 20 years old.
7) Written informed consent must be obtained from patients.
8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3supertype.
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 of effective contraception during and for at least 70 days after study participation.
4) Patients with the past history of cancer peptide vaccinations.
5) Patients with the past history of cancer peptide vaccinations.
Target sample size
100
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 Development Division
Zip code
Address
Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL
0942-31-7744
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
| 2013 | Year | 03 | Month | 01 | 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
| 2013 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 18 | 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=R000011787
