UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011230 |
|---|---|
| Receipt number | R000013157 |
| Scientific Title | Phase II Clinical trial of personalized peptide vaccine for patients with maligant tumors (gastrointestinal cancers, hepato-biliary-pancreatic cancers, thoracic malignant tumors, non-epithelial malignant tumors, genitourinary cancers, gynecological cancers, breast cancers, and rare cancers) - Effect of extended interval dosing on immune responses - |
| Date of disclosure of the study information | 2013/07/23 |
| Last modified on | 2019/12/06 14:54:54 |
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Basic information
Public title
Phase II Clinical trial of personalized peptide vaccine for patients with maligant tumors (gastrointestinal cancers, hepato-biliary-pancreatic cancers, thoracic malignant tumors, non-epithelial malignant tumors, genitourinary cancers, gynecological cancers, breast cancers, and rare cancers) - Effect of extended interval dosing on immune responses -
Acronym
Personalized peptide vaccine trial for patients with maligant tumors - Effect of extended interval dosing on immune responses -
Scientific Title
Phase II Clinical trial of personalized peptide vaccine for patients with maligant tumors (gastrointestinal cancers, hepato-biliary-pancreatic cancers, thoracic malignant tumors, non-epithelial malignant tumors, genitourinary cancers, gynecological cancers, breast cancers, and rare cancers) - Effect of extended interval dosing on immune responses -
Scientific Title:Acronym
Personalized peptide vaccine trial for patients with maligant tumors - Effect of extended interval dosing on immune responses -
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 |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to analyze the relationship between clinical effects and immune responses after extended interval dosing of the personalized peptide vaccination in the following malignant tumors(100patients/each); 1. lung cancers, 2. gastrointestinal cancers, 3. hepato-biliary-pancreatic cancers, 4. genitourinary cancers, 5. non-epithelial malignant tumors, 6. breast cancers, 7. gynecological cancers, 8. rare cancers
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 4 doses of vaccination
Key secondary outcomes
Adverse events and safety of personalized peptide vaccination evaluated by 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 4 doses with 21-28 day interval)
Vaccine peptides (up to 4), to which peptide-specific IgGs are detected, are selected from 31 candidate peptides before the 1st vaccination and s.c. inject to the patients.
(After 1st course: total 4 doses with 28-35 day interval) If the patient hopes to continue the vaccine treatment after completion of the 1st course 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
| 18 | 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. Target lesions for evaluating responses are not necessary.
2) Patients must be at a score level of 0 of performance status (PS) (ECOG).
3) Patients must have IgG reactive to at least two of candidate peptides in plasma before vaccination.
4)Patients must be expected to survive more than 4 months.
5) Patients must satisfy the followings:
WBC count is more than 2,500/mm3.
Lymphocyte count is more than 900/mm3.
Hb is more than 8.0g/dl.
Platelet count is more than 80,000/mm3.(50000/mm3 in hepatocellular carcinoma)
Serum Creatinine is less than 2 times upper limit of nomal (or less than 2.5 times upper limit of nomal in urological cancers).
Total Bilirubin is less than 2 times upper limit of nomal.
6) Patients must be more than 18 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 underlying diseases (active and severe infectious diseases, cardiovascular diseases, respiratory diseases, renal diseases, immunodeficiency, disturbance of coagulation).
2) Patients with the past history of severe allergic reactions.
3) Patients who are pregnant, nursing, or want to be pregnant. Patients with no acceptance of use of effective contraception during and at least 70 days after study participation.
4) Past history of usage of peptides employed in the study.
5) Patients who are judged inappropriate for enrollmwnt in this study by the attending doctors.
Target sample size
800
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
久留米大学病院・久留米大学医療センター（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 23 | 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 | 07 | Month | 18 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2013 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 22 | 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 | 07 | Month | 19 | 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=R000013157
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