UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized Phase II clinical trial of personalized peptide vaccination with low dose of cyclophosphamide for standard therapy failer Biliary cancer patients.
Title of the study (Brief title)	Randomized Phase II clinical of personalized peptide vaccination for standard therapy failed Biliary cancer.
Region	Japan

Condition
Condition	Biliary cancer
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Up to 4 from the 31 candidate peptides, to which peptide-specific IgGs are detected before vaccination, are administered to standard therapy failed Biliary cancer patients. The aim of the study is to investigate effects of low-dose cyclophosphamide on vaccine-induced, correlativity of overall survival and immuno responses.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Number of immuno-regulatory cells.
Key secondary outcomes	1. overall survival 2.Evaluation of immune responses (anti-peptide IgG,CTL). 3.Adverse effects of peptide vaccination safety of the protocol is evaluated based on the NCI-CTCAE.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	A:Personalized peptide vaccination with low dose of cyclophosphamide treatment. The cyclophosphamide of the low dosage (100mg / day) is administered for seven days before the day of tha peptide vaccine beginning. Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. 1st treatment:total 6 times,every 1 weeks 2nd treatment:total 6 times,eveyr 2 weeks and if the patient hopes, the treatment can be continued (at 2-6 week intervals ).
Interventions/Control_2	B:Personalized peptide vaccine alone Select vaccine peptides (up to 4) from 31 candidate peptides , to which peptide-specific IgGs are detected before vaccination. 1st treatment:total 6 times,every 1 weeks 2nd treatment:total 6 times,eveyr 2 weeks and if the patient hopes, the treatment can be continued (at 2-6 week intervals ).
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 with standard therapy failed Biliary cancer. Presence of target legion is 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 1000 per mm3 Hb is more than 8.0 g per dL Platelet is more than 50000 per mm3 Serum creatinine is less than 2.0mg per dL Total bilirubin is less than 2.5mg per dL 6) Patients must be more than 20 years old. 7) Written informed consent must be obtained from patients. 8) PatientsPatients 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. 5)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment.
Target sample size	44

Research contact person
Name of lead principal investigator	Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
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	Akira Yamada
Organization	Kurume University
Division name	Research Center for Innovative Cancer Therapy, Cancer Vaccine Development Division
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)

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 08 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 07 Month 15 Day
Anticipated trial start date	2011 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 08 Month 30 Day
Last modified on	2018 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007367