UMIN-CTR Clinical Trial

Basic information
Public title	Phase II clinical trial of personalized peptide vaccination for patient with advanced head and neck cancer resistant to standard therapies .
Acronym	Phase II clinical trial of personalized peptide vaccination for patient with advanced head and neck cancer resistant to standard therapies .
Scientific Title	Phase II clinical trial of personalized peptide vaccination for patient with advanced head and neck cancer resistant to standard therapies .
Scientific Title:Acronym	Phase II clinical trial of personalized peptide vaccination for patient with advanced head and neck cancer resistant to standard therapies .
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oto-rhino-laryngology Oral surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of study is to investigate the immunity-enhancing effects of personalized peptide vaccination for patient with malignancy resistant to standard therapies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Immune-enhancing effects (changes in anti-peptide IgG titers in plasma)
Key secondary outcomes	1.Analyze the correlation between enhancement of peptide specific antibody and all over survival. 2. Adverse events of peptide vaccination. Adverse events are evaluated by the NCI-CTCAE.

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	The right peptides (up to 4 peptides) for vaccination to individual patients will be selected in consideration of the pre-existing host immunity assessed by the titers of anti-peptide IgG before vaccination, and subcutaneously injected with incomplete Freund's adjuvant every week (3.0 mg/each peptide; 6 times/cycle). If the patients want to continue the vaccination after completion of the first cycle of 6 vaccinations, the peptide vaccination will be allowed to continue .
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	18 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 diagnosed as head and neck cancer resistant to standard therapies. Measurable lesions are not required. 2) Patients must be at a score level 0-1 of ECOG performance status. 3) Patients must have IgGs reactive to at least two of the candidate peptides restricted to the patient's HLA types. 4)Patients must be expected to survive more than 3 months. "5) Patient's laboratory data must satisfy the followings: WBC is more than 2,500/mm3 Lymphocyte is more than 900/mm3 Hb is more than 8.0g/dl Platelet is more than 80,000/mm3 Serum Creatinine is less than 2 times the ULN Total bilirubin are less than 2 times the ULN.(However, 2.5 or less times in the case of the patient of constitutional jaundice.) 6) Patients must be more 18 year-old. 7) Written informed consent must be obtained from patients. 8) Patients must be positive for HLA-A2, A24, A26, A3, A11, A31 or A33.
Key exclusion criteria	The following patients must be excluded: 1) Patients with severe underlying diseases/conditions (active and severe infectious diseases, circulatory diseases, respiratory diseases, ranal diseases, immunodeficiencies, disturbance of coagulation, et al). 2) Patients with the past history of severe allergic reactions. 3) (Females) Pregnant or nursing patients. Patients desiring future fertility. (Males) Patients who do not accept contraception from the 1st vaccination until 70 days after the last vaccination. 4) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigeru Yutani
Organization	Kurume University
Division name	Cancer Vaccine Center
Zip code
Address	Kokubu-machi 155-1, Kurume, Fukuoka 839-0863
TEL	0942-27-5210
Email	yutani@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	67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7572
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	2012 Year 08 Month 31 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	2012 Year 08 Month 23 Day
Date of IRB	2012 Year 08 Month 23 Day
Anticipated trial start date	2012 Year 08 Month 23 Day
Last follow-up date	2017 Year 08 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 08 Month 31 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=R000010349

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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