UMIN-CTR Clinical Trial

Basic information
Public title	Phase II Clinical trial of personalized peptide vaccine for patients with various types of cancers - Effect of sequencial change of vaccine antigens -
Acronym	Personalized peptide vaccine trial for cancer patients -Effect of sequencial change of vaccine antigens -
Scientific Title	Phase II Clinical trial of personalized peptide vaccine for patients with various types of cancers - Effect of sequencial change of vaccine antigens -
Scientific Title:Acronym	Personalized peptide vaccine trial for cancer patients -Effect of sequencial change of vaccine antigens -
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	The primary objective of this study is to analyze the effects of sequencial change of vaccine antigens with anti-peptide IgG in each cycle (6 vaccinations) of the personalized peptide vaccination on the clinical effects and the peptide-specific imune responses in patients after 2 cycles (12 times) of vaccinations.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Evaluation of antigen-specific immune responses after 12 and 18 times of vaccinations.
Key secondary outcomes	1. Adverse effects and safety of personalized peptide vaccination are evaluated based on the CTCAE Version 4.0 2. Overall survival

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	For patients with HLA-A2, -A24, -A26, or -A3 supertype, HLA-matched vaccine peptides (maximum 4 peptides) with anti-peptide IgG in plasma are administered with Freund incomplete adjuvant. Each peptide (3 mg/peptide) are subcutaneously injected at separate sites once a week at the first cycle of 6 vaccinations and every 2-4 weeks at the second cycle of 6 vaccinations or at the third cycle of 6 vaccinations. The patients can receive more cycles of vaccinations, if the situation allows. Selection of vaccine peptides for each patient is performed according to the plasma IgG titers to the candidate peptides. At the first cycle, HLA-matched vaccine peptides (maximum 4 peptides) with higher IgG titers are selected. At the second cycle, another combination of HLA-matched vaccine peptides (maximum 4 peptides) with higher IgG titers, which have not been employed before, is selected. At the third cycle, another combination of HLA-matched vaccine peptides (maximum 4 peptides) with higher IgG titers, which have not been employed before, is selected.
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,they do not need to possess target lesions for response evaluation. 2) Patients must be at the performance status(PS) score levels of 0 to 2 (ECOG). Exceptionally, PS3 patients only in neurological symptom can be enrolled. 3) Patients must have IgG reactive to at least two of HLA-matched candidate peptides in plasma. 4) Patients must be expected to survive more than 3 months. 5) Patients must satisfy the followings: WBC number is more than 2,500/mm3 Lymphocyte number is more than 1,000/mm3 Hb is more than 8.0g/dl Platelet number is more than 80,000/mm3. Exceptionally, platelet number is more than 50,000/mm3 in lirer cancer Serum creatinine is less than 2 times of upper limit of nomal. Total bilirubin is less than 2 times of upper limit of nomal. 6) Patients must be more than 20 years old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2,HLA-A24, HLA-A26, or HLA-A3supertype.
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) Pregnant, nursing, or who wants pregnancy. Patients with no acceptance of use of effective contraception during and for at least 70 days after study participation. 4) Patients with the past history of cancer peptide vaccinations. 5) Patients with the past history of cancer peptide vaccinations.
Target sample size	100

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 Development Division
Zip code
Address	Asahi-machi 67, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7744
Homepage URL
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
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information	2013 Year 03 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	2013 Year 02 Month 04 Day
Date of IRB	2013 Year 02 Month 04 Day
Anticipated trial start date	2013 Year 03 Month 01 Day
Last follow-up date	2016 Year 12 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	2013 Year 02 Month 18 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=R000011787