UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Clinical trial of personalized peptide vaccine for cancer patients
Acronym	Personalized peptide vaccine trial for cancer patients
Scientific Title	Phase II Clinical trial of personalized peptide vaccine for cancer patients
Scientific Title:Acronym	Personalized peptide vaccine trial for cancer patients
Region	Japan

Condition
Condition	malignant tumor
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Pneumology Hematology and clinical oncology Gastrointestinal surgery Hepato-biliary-pancreatic surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Dermatology Oto-rhino-laryngology Orthopedics Urology Radiology Oral surgery Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This clinical trial is the personalized peptide vaccination for cancer patients. Peptides, identifed as vaccine candidates for cancer patients,which is recognized by patient's serum are administered subcutaneously. The aim of this study is to investigate the enhancement of peptide specific antibody in vaccinated patient.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Evaluation of the peptide specific antibody before and after vaccination.
Key secondary outcomes	Analyze the correlation between enhancemt of peptide specific antibody and all over survival. Adverse events of peptide vaccination are evaluated based on the CTCAE v3.0 (JCOG).

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Vaccine
Interventions/Control_1	Peptides (maximum 4) among 27 (for HLA-A2, -A24, -A26, and -A3 super type) peptides, which were identified as vaccine candidates for cancer patients, are administered with Freund incomplete adjuvant. Vaccine peptide selection for each patient will be performed according to the reactivity of pre-vaccination plasma IgG to the candidate peptides. Each emulsified peptide (3 mg/peptide) are separately injected into subcutaneous once a week for 6-weeks (total 6 times). Blood samples for hematology and biochemistry are taken the beginning of vaccination.
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 and Female
Key inclusion criteria	The subjects must satisfy the following conditions. 1)Patients must be pathologically diagnosed as cancer, however, it is not necessary to possess target lesions for response evaluation. 2)Patients must be at a score level of 0-2 of performance status (PS) (ECOG). Exceptionally, PS3 patients only in neurological symptom can be enrolled. 3)Patients must have significant level of plasma IgG reactive to at least two of the vaccine candidate peptides. 4) Patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings: WBC more than 2,500/mm3 Lymphocytes more than 1,000/mm3 Hb more than 8.0g/dl Platelet more than 80,000/mm3 Serum Creatinine less than 2x normal upper limit Total Bilirubin less than 2x normal upper limit 6)Patients must be more than 20 year-old. 7)Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2, -A3, -A11, -A24, -A26, -A31, or -A33.
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 etc). 2) Patients with the past history of severe allergic reactions. 3) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use effective contraception during and for at least 70 days after study participation. 4) Patients who are judged inappropriate for the clinical trial by doctors.
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masanori Noguchi
Organization	Kurume University
Division name	Research Center for Innovative Cancer Therapy
Zip code
Address	Asahi-machi 67, Kurume, Fukuoka 830-0011
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
Division name	Research Center for Innovative Cancer Therapy, Cancer Vaccine Department Division
Zip code
Address	Asahimachi 67, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7551
Homepage URL	http://www.med.kurume-u.ac.jp/med/immun/F/
Email	akiymd@med.kurume-u.ac.jp

Sponsor
Institute	Kurume University Cancer Vaccine Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Sendi public welfare hospital
Name of secondary funder(s)	The Ministry of Education, Culture, Sports, Science, and Technology, Japan

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	仙台厚生病院（宮城県）Sendi public welfare hospital

Other administrative information
Date of disclosure of the study information	2008 Year 11 Month 05 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	2008 Year 10 Month 10 Day
Date of IRB	2008 Year 10 Month 10 Day
Anticipated trial start date	2008 Year 11 Month 01 Day
Last follow-up date	2013 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2008 Year 11 Month 05 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=R000001740