UMIN-CTR Clinical Trial

Basic information
Public title	A phase II trial of personalized peptide vaccination for several cancer patients with slight bone marrow suppression
Acronym	A phase II trial of peptide vaccination for several cancer patients with slight bone marrow suppression
Scientific Title	A phase II trial of personalized peptide vaccination for several cancer patients with slight bone marrow suppression
Scientific Title:Acronym	A phase II trial of peptide vaccination for several cancer patients with slight bone marrow suppression
Region	Japan

Condition
Condition	Cancer patients who are under standard treatments or resistant to standard treatments with slight bone marrow suppression
Classification by specialty	Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Nephrology Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Breast surgery Obsterics and gynecology Dermatology Oto-rhino-laryngology Orthopedics Urology Oral surgery Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the immunological responses of personalized peptide vaccination for several cancer patients who are under standard treatments or resistant to standard treatments with slight bone marrow suppression
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Assessment of immunoresponses by mesurement of peptide specific IgGs
Key secondary outcomes	1.Safety assessment 2.Overall survival

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	4 peptide vaccines are selected from 31 peptide restrcted by HLA-class I based on higher peptide-specific IgG responses before vaccination. Selected peptides are separately and subcutaneously injected (3.0mg/peptide) every 1 week interval for 6 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 who are during or resistant to standard treatment of Prostate, Urothelium, Kidney, Brain, Head and Neck, Lung, Esophagus, Stomach, Liver, Biliary tract, Pancreas, Colon, Ovary, Uterus, Breast, Sarcoma, Hematapostema, Skin, Primary unknown cancer and Rare cancer. 2)Patients must be at a score level of 0-2 of performance status(PS)(ECOG). 3)Patients must have IgGs reactive to at least 2 peptides from 31 candidate peptides restricted to the patient's HLA types. 4)Patients must be expected to survive more than 3 months. 5)Patient's laboratory data must satisfy the followings: WBC > and = 2000/mm3 Lymphocyte 500-900/mm3 Hb > and = 8.0 g/dL Platelet > and = 50000/mm3 Serum Creatinine < and = 2.0mg/dL Serum Total Bilirubin < and = 2.5mg/dL 6)Patients must be more 18 years-old. 7)Written informed consent must be obtained from patients. 8)Patients must be positive for HLA-A2,A24,A26,A3,A11,A31,A33
Key exclusion criteria	The following patients must be excluded. 1)Patients with severe underlying diseases/ conditions(active and severe infectious disease, circulatory disease, respiratory disease, kidney disease, immunodeficiency, disturbance of coagulation etc.) 2)Patients with the past history of severe allergic reactions. 3)(Females) Pregnant or nursing patients. Patients desiring future fertility. (Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 4)Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size	1000

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	155-1 Kokubu-machi Kurume-city Fukuoka-Pref JAPAN, 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	155-1 Kokubu-machi Kurume-city Fukuoka-Pref JAPAN, 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	None
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） 内藤病院（福岡県）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 19 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	2015 Year 10 Month 16 Day
Date of IRB	2015 Year 10 Month 16 Day
Anticipated trial start date	2015 Year 10 Month 19 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	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 10 Month 17 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=R000022423