UMIN-CTR Clinical Trial

Basic information
Public title	A randomized clinical trial of personalized peptide vaccination with oral low-dose metronomic cyclophosphamide for metastatic castration-resistant prostate cancer (CRPC)
Acronym	Personalized peptide vaccination with metronomic cyclophosphamide for metastatic CRPC
Scientific Title	A randomized clinical trial of personalized peptide vaccination with oral low-dose metronomic cyclophosphamide for metastatic castration-resistant prostate cancer (CRPC)
Scientific Title:Acronym	Personalized peptide vaccination with metronomic cyclophosphamide for metastatic CRPC
Region	Japan

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

Objectives
Narrative objectives1	To investigate ability of oral metronomic cyclophosphamide with personalized peptide vaccination to deplete immuno-suppression cells in metastatic CRPC patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Evaluation of ability of oral metronomic cyclophosphamide with personalized peptide vaccination to deplete immuno-suppression cells.
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. 3. Evaluation of immunological responses (cytotoxic T lymphocytes [CTL]and anti-peptide IgG) before and after peptide vaccination.

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	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	A: Personalized peptide vaccination with oral metronomic cyclophosphamide treatment Select peptide candidates (up to 4), 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. Start oral use of cyclophosphamide 1T (1X) (50 mg/day, 50 days) on the same day with peptide vaccination. 1st treatment: total 8 times, every weeks) After the first cycle of 8 vaccinations, the peptides were re-selected according to the titers of peptide-specific IgG at every cycle of 8 vaccinations and administered at 2, 3, or 4 week intervals until unacceptable toxicity or withdrawal of consent.
Interventions/Control_2	B: Personalized peptide vaccine alone Select peptide candidates (up to 4), 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. After the first cycle of 8 vaccinations, the peptides were re-selected according to the titers of peptide-specific IgG at every cycle of 8 vaccinations and administered at 2, 3, or 4 week intervals until unacceptable toxicity or withdrawal of consent.
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 metastatic castration-resistant prostate cancer after standard treatment. 2) Patients must be positive for HLA-A2, HLA-A24 or HLA-A3 super type. 3) Patients must have IgG reactive to at least two of 31 peptide candidates. 4) Patients must be at a score level of 0-1 of performance status (PS) (ECOG). 5) Patients must be expected to survive more than 3 months. 6) Patients must satisfy the followings: WBC > 2,500/mm3 Lymphocyte > 1,000/mm3 Hb > 8.0g/dl Platelet > 100,000/mm3 Serum Creatinine < 2.5 x upper limit of normal Total Bilirubin < 2 x upper limit of normal 7) Patients must be more 20 year-old. 8) 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) Patients with the past history of severe allergic reactions. 3) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Masanori Middle name Last name Noguchi
Organization	Kurume University School of Medicine
Division name	Research Center for Innovative Cancer Therapy, Division of Clinical Research Department of Urology
Zip code	830-0011
Address	Asahi-machi 67, Kurume, Japan
TEL	0942-31-7989
Email	noguchi@med.kurume-u.ac.jp

Public contact
Name of contact person	1st name Akira Middle name Last name Yamada
Organization	Kurume University School of Medicine
Division name	Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division
Zip code	830-0011
Address	Asahi-machi 67, Kurume, Japan
TEL	0942-31-7572
Homepage URL
Email	akiymd@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University School of medicine, Department of Immunology and immunotherapy
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)	Kurume University

IRB Contact (For public release)
Organization	Kurume University School of Medicine
Address	67 Asahi-machi, Kurume, Japan
Tel	0942-35-3311
Email	sangaku@kurume-u.ac.jp

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 (福岡県)　Kurume University Hospital

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 01 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	2011 Year 03 Month 28 Day
Date of IRB	2011 Year 03 Month 28 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2015 Year 03 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	2011 Year 03 Month 28 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=R000006331