UMIN-CTR Clinical Trial

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