UMIN-CTR Clinical Trial

Basic information
Public title	A phase II clinical trial of personalized peptide vaccination in combination with metformin for castration-resistant prostate cancer (CRPC)
Acronym	Personalized peptide vaccination with metformin for CRPC
Scientific Title	A phase II clinical trial of personalized peptide vaccination in combination with metformin for castration-resistant prostate cancer (CRPC)
Scientific Title:Acronym	Personalized peptide vaccination with metformin for CRPC
Region	Japan

Condition
Condition	Castration-resistant prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of study is to investigate the immunity-enhancing effects, safety , clinical efficacy of personalized peptide vaccination in combination with metformin for castration-resistant prostate cancer patients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Assessment of immune responses by measurement of cytotoxic T lymphocytes (CTL)and anti-peptide IgG) before and after peptide vaccination with metformin.
Key secondary outcomes	1.Evaluation of long-term prognosis (progression free survival and overall survival). 2.Adverse effects of peptide vaccination / The safety of the protocol is evaluated based on the NCI-CTC.

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 cycle: (Personalized peptide vaccination alone) 4 peptide vaccines are selected from 31 peptide candidates restricted by HLA-class I, to which peptide-specific IgGs are detected before vaccination, and administer peptides (maximum 4) that showed the highest reactivity. Emulate these peptides individually and subcutaneously inject them separately (3.0 mg/1.5-3.0 ml/peptide) every 1 week interval: total 8 times, every weeks. After 1st cycle: (Personalized peptide vaccination in combination with metformin) Start oral use of metformin (500mg/day, 2X, every days) with personalized peptide vaccination. If the patients want to continue the vaccination after completion of the second cycle of 8 vaccinations, the peptide vaccination with metformin will be allowed to continue (every 3-4 weeks) until unacceptable toxicity or withdrawal of consent.
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
Key inclusion criteria	The subjects must satisfy the following conditions. 1) Patients must be diagnosed as prostate cancer pathologically at the initial treatment. The patients must be suffering from castration-resistant prostate cancer after standard treatment. 2) Patients have not been diagnosed as diabetes, and patients must satisfy the followings: HbA1c < and = 6.5% Patients do not receive medical therapy using the diabetes medicine (including an oral hypoglycemic drug, the insulin therapy). 3) Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 4) Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type. 5) Patients must have IgG reactive to at least two of peptide the candidate peptides restricted to the patient's HLA types. 6) Patients must satisfy the followings: WBC >and= 2,500/mm3 Lymphocyte >and=1,000/mm3 Hb >and= 8.0g/dl Platelet >and= 80,000/mm3 Serum Creatinine <and= 1.5x upper limit of normal Total Bilirubin <and=2x upper limit of normal AST, ALT <and = 2x upper limit of normal 7) Patients must be more 20 year-old. 8) Patients must be expected to survive more than 3 months. 9) Written informed consent must be obtained from patients.
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)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. 3) Patients with the past history of severe allergic reactions. 4) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 5) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size	35

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masanori Noguchi
Organization	Kurume University School of Medicine
Division name	Research Center for Innovative Cancer Therapy, Division of Clinical Research
Zip code
Address	Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
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 School of Medicine
Division name	Research Center for Innovative Cancer Therapy, Division of Cancer Vaccine
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	Cancer Vaccine Center, Kurume University School of medicine
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)	Kurume University

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	久留米大学病院医療センター（福岡）Kurume University Medical Center (Fukuoka)

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 24 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 11 Month 17 Day
Date of IRB	2015 Year 11 Month 17 Day
Anticipated trial start date	2015 Year 11 Month 24 Day
Last follow-up date	2020 Year 11 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	2015 Year 11 Month 20 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=R000022966