UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Clinical trial of personalized peptide vaccine for cancer patients - Effect of extended dose interval on the immun induction -
Acronym	Personalized peptide vaccine trial for cancer patients - Effect of extended dose interval on the immun induction -
Scientific Title	Phase II Clinical trial of personalized peptide vaccine for cancer patients - Effect of extended dose interval on the immun induction -
Scientific Title:Acronym	Personalized peptide vaccine trial for cancer patients - Effect of extended dose interval on the immun induction -
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 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 effect of extended dose intervals of the personalized peptide vaccination on the enhancement of peptide-specific IgG for patients with various malignant tumors from foreign countries or distant places.
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 3 dose vaccination.
Key secondary outcomes	Adverse effects and safety of peptide vaccination is evaluated based on 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 3 doses with 21-28 day interval) Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before the 1st vaccination, and s.c. inject to the patient. If the patient hopes to continue the vaccine treatment after completion of Course 1 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	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,it is not necessary to possess target lesionns response evaluation. 2) Patients must be at a score level 0 of performance status (PS) (ECOG). 3) Patients must have IgG reactive to at least two of candidate peptides. 4)Patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings: WBC is more than 2,500/mm3 Lymphocyte is more than 1,000/mm3 Hb is more than 8.0g/dl Platelet is more than 80,000/mm3 Serum Creatinine is less than 2 times upper limit of nomal. Total Bilirubin is less than 2 times upper limit of nomal. 6) Patients must be more 20 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 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 effective contraception during and for at least 70 days after study participation. 4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size	60

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	0942-31-7572
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	0942-31-7572
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

Other administrative information
Date of disclosure of the study information	2011 Year 12 Month 21 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	2011 Year 12 Month 09 Day
Date of IRB	2011 Year 12 Month 09 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 12 Month 21 Day
Last modified on	2019 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008175