UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II clinical trial of personalized peptide vaccination for decetaxel no indicated patients with hormone-refractory prostate cancer
Title of the study (Brief title)	Personalized peptide vaccination for hormone-refractory prostate cancer patients
Region	Japan

Condition
Condition	Prostate cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate clinical effects and safety of the peptide vaccine, peptides (maximum 4) among 12 peptides, which were identified as vaccine candidates for HLA-A24+ cancer patients, are administered into hormone-refractory prostate prostate cancer patients after confirmation of peptide-specific IgG in patients. Primary endpoint is overall survival of the patients, and the secondary endpoints are progression free survival, 12 month survival rate, anti-tumor effect (clinical responses), adverse effects (evaluation of safety), and immunological responses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Overall survival of peptide vaccination with BSC will be compared with that of BSC patients who are not enrolled this study.
Key secondary outcomes	1. Progression free survival of peptide vaccination with BSC will be compared with that of BSC group. 2. 12 month survival rate of the 2 groups will be compared. 3. Anti-tumor effect (clinical responses) will be evaluated by RECIST criteria. 4. Adverse effects/safety will be evaluated by CTCAE v.3.0. 5. Evaluation of immunological effects (cytotoxic T lymphocytes (CTL), anti-peptide IgG) before and after peptide vaccination.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Vaccine
Interventions/Control_1	<1st treatment: total 8 times, every week> Day 1: 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. Emulsion of the peptides is subcutaneously injected (3.0 mg/1.5 mL). Simultaneous BSC treatments are accepted. Day 8,15,22,29,36,43,50: Inject subcutaneously the same peptides as those of the 1st injection. Day 50-64: Final evaluation. <2nd treatment: total 8 times, every 2 weeks> The 2nd treatment would be continued according to the patient's request. The peptides are bi-weekly injected. When adverse effects would be observed, the interval of vaccination and the doses of peptides could be modified.
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 after the treatment of castration, LH-RH analogue therapy, anti-androgen therapy, or female hormone therapy. 2. Patients must be decetaxel no indicated. 3. Patients must be at a score level of 0-2 of performance status (PS) (ECOG). Patient with PS3 is acceptable if limited to neural symptoms. 4. Patients must be positive for HLA-A24. 5. Patients must have IgG reactive to at least two of peptide candidates. 6. Patients must be expected to survive more than 3 months. 7. Patients must satisfy the followings: WBC >3,000/mm3 Lymphocyte >900/mm3 Hb >8.0g/dL Platelet >75,000/mm3 Serum Creatinine >2.0 mg/dL Total Bilirubin >1.5 mg/dL 8. Patients must be more 20 years old. 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) Patients with multiple cancers 3) Patients with the past history of severe allergic reactions. 4) Patients who are not accept contraception during the 1st vaccination to 70 days after the last vaccination. 5) Patients with positive for hepatitis B or C virus. 6) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size	55

Research contact person
Name of lead principal investigator	Masanori Noguchi
Organization	Kurume University
Division name	Research Center for Innovative Cancer Therapy, Clinical Research Division
Address	67 Asahi-machi,Kurume-shi,Fukuoka-ken 830-0011 Japan
TEL	0942-31-7989
Email	noguchi@med.kurume-u.ac.jp

Public contact
Name of contact person	Masanori Noguchi
Organization	Kurume University
Division name	Research Center for Innovative Cancer Therapy, Clinical Research Division
Address	67 Asahi-machi,Kurume-shi,Fukuoka-ken 830-0011 Japan
TEL	0942-31-7989
Homepage URL
Email	akiymd@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University Research Center for Innovative Cancer Therapy, Clinical Research Division
Institute
Department

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

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	The Ministry of Health, Labor and Welfare, Japan

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	2008 Year 07 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 07 Month 08 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date	2017 Year 05 Month 31 Day
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	2008 Year 07 Month 10 Day
Last modified on	2017 Year 11 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001514