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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019879
Receipt No. R000022966
Scientific Title A phase II clinical trial of personalized peptide vaccination in combination with metformin for castration-resistant prostate cancer (CRPC)
Date of disclosure of the study information 2015/11/24
Last modified on 2015/11/20

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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 Open public recruiting
Date of protocol fixation
2015 Year 11 Month 17 Day
Date of IRB
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
2015 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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