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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005329
Receipt No. R000006331
Scientific Title A randomized clinical trial of personalized peptide vaccination with oral low-dose metronomic cyclophosphamide for metastatic castration-resistant prostate cancer (CRPC)
Date of disclosure of the study information 2011/04/01
Last modified on 2019/12/06

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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

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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