UMIN-CTR Clinical Trial

Basic information
Public title	Phase II randomised clinical trial of personalized peptide vaccination in combination with Dai-kenchu-to for colorectal cancer patients resistant to standard therapies.
Acronym	Phase II study of personalized peptide vaccination in combination with Dai-kenchu-to for colorectal cancer patients.
Scientific Title	Phase II randomised clinical trial of personalized peptide vaccination in combination with Dai-kenchu-to for colorectal cancer patients resistant to standard therapies.
Scientific Title:Acronym	Phase II study of personalized peptide vaccination in combination with Dai-kenchu-to for colorectal cancer patients.
Region	Japan

Condition
Condition	colorectal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of study is to investigate the immunity-enhancing effects, safety , clinical efficacy of personalized peptide vaccination in combination with Dai-kenchu-to for colorectal cancer patients 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	Comparison of immune-enhancing effects (changes in anti-peptide IgG titers in plasma)between two groups.
Key secondary outcomes	1.Comparison of peptide-specific CTL responses in PBMCs between two groups. 2. Comparison of safety between two groups. 3. Comparison of overall survival between two groups .

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
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	arm1: 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). Dai-kenchu-to(5 g/time, 3 times/day) will be orally administered from the date of the first vaccination to the date of the sixth vaccination. 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 (every 2-4 weeks).
Interventions/Control_2	arm2: 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 (every 2-4 weeks).
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 diagnosed as colorectal 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 1,000/mm3 Hb is more than 8.0g/dl Platelet is more than 50,000/mm3 Serum Creatinine is less than 2.0mg/dl AST(GOT),ALT(GPT),ALP,gGTP, and total bilirubin are less than 2 times the ULN. 6) Patients must be more 20 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)Active double cancer (synchronous double cancer and metachronous double cancer within 5 disease-free years), excluding carcinoma in situ (lesions equal to intraepithelial or intramucosal cancer) judged to have been cured with local treatment. 3) Patients with the past history of severe allergic reactions. 4)Patients with the interstitial pneumonia or with the past history of this disease. 5) (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. 6) Patients who are judged inappropriate for entry to this clinical trial by doctors.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Middle name Last name Teturo Sasada
Organization	Kurume University
Division name	Department of Immunology
Zip code
Address	67 Asahi-machi, Kurume, Fukuoka 830-0011, Japan
TEL	0942-31-7551
Email	tsasada@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 06 Month 08 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 06 Month 04 Day
Date of IRB	2012 Year 06 Month 04 Day
Anticipated trial start date	2012 Year 06 Month 04 Day
Last follow-up date	2019 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	2012 Year 06 Month 08 Day
Last modified on	2019 Year 10 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009568