UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase I study of a 5-peptide vaccine with immune modulators for patients with refractory metastatic colorectal cancer
Title of the study (Brief title)	A 5-peptide vaccine with immune modulators for patients with metastatic colorectal cancer
Region	Japan

Condition
Condition	refractory metastatic colorectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To test the safety and immune responses of a 5-peptide vaccine and immune modulators in patients with refractory metastatic colorectal cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	The safety of the immune modulators with/without 5-peptide cocktail vaccine
Key secondary outcomes	1) peptide-specific CTL responses and the relationship with clinical responses 2)Overall survival and preogression-free survival

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	1)Immune modulators, composed of cyclophosphamide, metformin, celecoxib and cimetidine are administered orally for 1 week 2)Induction phase: 5-peptide cocktail vaccine weekly in combination with immune modulators are administered for 8 weeks 3)Maintenance phase: 5-peptide cocktail vaccine biweekly in combination with immune modulators are administered for 8 weeks 4)Extension phase: maintenance therapy is allowed depending on patient condition
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	1)standard therapy-refractory metastatic colorectal cancer 2)HLA-A24 positive patient 3)life expectancy at least 3 months 4)older than 20 years of age 5)ECOG performance status, 0,1 or 2 6)having measurable metastatic lesion 7) WBC count more than 2,000 and % of lymphocyte more than 15% 8)adequate bone marrow, liver and renal function
Key exclusion criteria	1)patient having double cancer 2)patient having interstitial pneumonia 3)patient having brain metastasis 4)patient having mental disorder 5)patient having uncontrollable heart disorder, pulmonary disorder or renal disorder 6)patient having bleeding tendency 7)patient having any allergic reaction to using drugs
Target sample size	12

Research contact person
Name of lead principal investigator	Kiyotaka OKUNO
Organization	Kindai University Faculty of Medicine
Division name	Department of Surgery
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL	072-366-0221
Email	okuno@surg.med.kindai.ac.jp

Public contact
Name of contact person	Junichiro KAWAMURA
Organization	Kindai University Faculty of Medicine
Division name	Department of Surgery
Address	377-2 Ohno-higashi, Osaka-sayama, Osaka
TEL	072-366-0221
Homepage URL
Email	kawamuraj@surg.med.kindai.ac.jp

Sponsor
Institute	Department of Surgery, Kindai University Faculty of Medicine
Institute
Department

Funding Source
Organization	Department of Surgery, Kindai University Faculty of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	近畿大学医学部附属病院外科（大阪府）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 20 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2017 Year 02 Month 03 Day
Anticipated trial start date	2017 Year 03 Month 20 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 05 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2017 Year 08 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030046