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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011230
Receipt No. 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 2019/01/07

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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
Obsterics 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
Last 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
Email noguchi@med.kurume-u.ac.jp

Public contact
1st 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
Email akiymd@med.kurume-u.ac.jp

Sponsor
Institute Kurume University CanCER Vaccine Center
Institute
Department

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
Email

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 No longer recruiting
Date of protocol fixation
2013 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 23 Day
Last follow-up date
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 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013157

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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