UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients
Acronym	A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients
Scientific Title	A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients
Scientific Title:Acronym	A phase II trial of personalized peptide vaccination for rare cancer or primary unknown cancer patients
Region	Japan

Condition
Condition	Rare cancer or primary unknown cancer
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Obsterics and gynecology Dermatology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Up to 4 from 31 candidate peptides, in which peptide-specific IgGs are detected before vaccination, are administered subcutaneously to rare cancer or primary unknown cancer patients. The aim of this study is to investigate the correlation between immunological responses and overall survival.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Assesment of immunoresponses by measurement of peptide-specific IgGs and CTL responses by ELISPOT assay.
Key secondary outcomes	1. Analyze of correlation between immunological responses and overall survival. 2. Safety assessment

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Vaccine
Interventions/Control_1	Personalized peptide vaccination are selected from 31 peptides restricted on higher peptide-specific IgG responses before vaccination. Selected peptides are separately and subcutaneously injected(3.0mg/3.0ml/peptide) 1 week interval for 4 times and 2 weeks interval for 4 times (Total 8 times).
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 diagnosed as malignant tumor and divided into rare cancer or primary unknown cancer. However, we don't make conditions that have evaluational lesion or clinical stage. 2)Patients must be at a score level of 0-1 of performance status(PS)(ECOG). 3)Patients must have IgG reactive to at least 2 peptides from 31 peptides restricted by HLA-class I. 4)Patients must be expected to survive more than 3 months. 5)Patients must satisfy the followings: WBC >and= 2500/mm3 Lymphocyte >and= 1000/mm3 Hb >and= 8.0g/dL Plt.>and= 80000/mm3 Serum Creatinine < and= 2.0 x upper limit of normal Total Bilirubin < and= 2.0 x upper limit of normal 6)Patients must be more 18 year-old. 7)Written informed consent must be obtained from patients. 8)Patients must be positive for HLA-class I (-A2,-A24,-A26,-A3,-A11,-A31 or-A33)
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 and disturbance of coagulation). 2)Patients with the past history of severe allergic reactions. 3)(Female) Patients who are pregnancy,lactation and hope the graviditas. (male) Patient who do not agree prevebt pregnancy. 4)Patients who are judged inappropriate for entry to this clinical trial by doctor in charge.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
Zip code
Address	Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL	0942-27-5210
Email	yutani@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
Zip code
Address	Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL	0942-27-5210
Homepage URL	http://www.med.kurume-u.ac.jp/med/cvc/
Email	yutani@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University Cancer Vaccine Center
Institute
Department

Funding Source
Organization	Kurume University Cancer Vaccine Center
Organization
Division
Category of Funding Organization	Self funding
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	久留米大学がんワクチンセンター（福岡県）、久留米大学病院（福岡県）、内藤病院（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 14 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	2014 Year 07 Month 18 Day
Date of IRB	2014 Year 07 Month 18 Day
Anticipated trial start date	2014 Year 08 Month 14 Day
Last follow-up date	2019 Year 07 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	2014 Year 08 Month 13 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=R000017261