UMIN-CTR Clinical Trial

Basic information
Public title	Phase II clinical trial of personalized peptide vaccination for urotherial cancer patients
Acronym	Peptide vaccination for urotherial cancer patients
Scientific Title	Phase II clinical trial of personalized peptide vaccination for urotherial cancer patients
Scientific Title:Acronym	Peptide vaccination for urotherial cancer patients
Region	Japan

Condition
Condition	Urotherial cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Up to 4 from the 31 candidate peptides, to which peptide specific IgG are detected before vaccination,are administered to malignant urotherial cancer patients. The aim of the study is to investigate immune response and also analyze a relationship between the immune response and overall survival.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Evaluation of immune responses (anti-peptide IgG) before and after personalized peptide vaccination.
Key secondary outcomes	1. Evaluation of long-term prognosis (progression free survival and overall survival). 2. Adverse events of personalized peptide vaccination. Adverse events are evaluated by the NCI-CTCAE.

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 treatment: total 8 times, which include weekly injection for 4 times followed by bi-weekly injection for 4 times> Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. Individually emulsify these peptides with IFA and subcutaneously inject (3.0 mg/peptide).
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 be satisfactory the following conditions. 1) patients must be diagnosed as urotherial cancer. Presence of target legion, former treatment, and disease stage are not considered. 2) patients must be at a score level 0-1 of ECOG performance status. 3) patients must have IgGs reactive to at least two of candidate peptides belongs to an apropriate group(s) for patient's HLA types. 4) patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings. WBC is more than 2500 per mm3 Lymphocyte is more than 900 per mm3 Hb is more than 8.0 g per dL Platelet is more than 80000 per mm3 Serum creatinine is less than 2.5 times upper limit of normal. Total bilirubin is less than 2 times upper limit of normal. (for constitutional jaundice, 2.5 times less or equal) 6) patients must be more than 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 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, disturbance of coagulation). 2) Patients with the past history of severe allergic reactions. 3) (Females) Patients who are during pregnancy, lactation expectant, and desiring future fertility. (Males) Patients do not accept contraception during the 1st vaccination to 70 days after the last vaccination." 4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size	100

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 Development Division
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
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

Other administrative information
Date of disclosure of the study information	2010 Year 01 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	2009 Year 12 Month 18 Day
Date of IRB	2009 Year 12 Month 18 Day
Anticipated trial start date	2010 Year 01 Month 01 Day
Last follow-up date	2014 Year 12 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	2010 Year 01 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=R000003713