UMIN-CTR Clinical Trial

Basic information
Public title	Phase I study safety and immunogenicity of vaccination with XAGE1 long peptides in patients with advanced lung adenocarcinoma
Acronym	XAGE1 cancer vaccine against advanced lung adenocaricinoma
Scientific Title	Phase I study safety and immunogenicity of vaccination with XAGE1 long peptides in patients with advanced lung adenocarcinoma
Scientific Title:Acronym	XAGE1 cancer vaccine against advanced lung adenocaricinoma
Region	Japan

Condition
Condition	Advanced lung adenocarcinoma
Classification by specialty	Pneumology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the safety and immunogenecity of XAGE1 cancer vaccine
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I

Assessment
Primary outcomes	Adverse events
Key secondary outcomes	XAGE1 antibody respose

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Dose comparison
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine Vaccine
Interventions/Control_1	XAGE1 cancer vaccine 0.5mg will be administered 4 times every 2 week.
Interventions/Control_2	XAGE1 cancer vaccine 1mg will be administered 4 times every 2 week.
Interventions/Control_3	XAGE1 cancer vaccine 2mg will be administered 4 times every 2 week.
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)XAGE1 expression or XAGE1 antibody positive advanced lung adenocarcinoma (2)Patients with refractory or intolerable to standard therapy, patients who have no standard therapy or refuse standard therapy. (3)Performance status 0-2 (4)Patients should be 20 years or older at informed consent. (5)patients did not received anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease within 4 weeks. (6)Life expectancy >= 3 months (7) No serious disorder of major organs (bone marrow, heart, lung, liver and kidney) and meet the following conditions. 1) WBC count: >=1,500/mm3 2) Hemoglobin: >=8.0g/dL 3) Platelet count: >=100,000/mm3 4) Serum total bilirubin: <=1.5 x ULN 5) AST and ALT: <=2.5 x ULN 6) Serum creatinine: <=1.5 mg/dL (8)Given written informed consent. (9)Without the history of penicillin hypersensitivity.
Key exclusion criteria	(1) Patients with HIV antibody positive. (2) Patients with HCV antibody positive. (3) Patients with HBs antigen or HBV-DNA positive. (4) Patients with active autoimmune disease. (5) History of serious anaphylaxis induced by antibody preparation. (6) Within 4 weeks after treatment with anticancer agent, immune suppressant, immune enhancer, cytokine therapy, radiotherapy or surgery for the primary disease. (7) Patients with double cancer. (8) Patients who need continuous systemic administration of adrenocorticosteroid. (9) Refuse to use birth control including condom etc. from the time of obtaining the first consent to 24 weeks after the final administration of the study drug (except female after menopause (1 year or more after the last menstruation) and female/male after the operation for sterilization). (10) Patients with active infection. (11) Patients with psychosis or dementia. (12) Patients who have received hematopoietic stem cell transplantation. (13) Any other inadequacy for this study.
Target sample size	9

Research contact person
Name of lead principal investigator	1st name MIKIO Middle name Last name OKA
Organization	Kawasaki Medical School
Division name	Immuno-Oncology
Zip code	701-0192
Address	577 Mastushima, Kurashiki, Okayama
TEL	086-462-1111
Email	resp@med.kawasaki-m.ac.jp

Public contact
Name of contact person	1st name KOJI Middle name Last name KUROSE
Organization	Secretariat of clinical trial coordinating committee
Division name	(none)
Zip code	701-0192
Address	577 Mastushima, Kurashiki, Okayama
TEL	086-462-1111
Homepage URL
Email	kuro-ko.66@med.kawasaki-m.ac.jp

Sponsor
Institute	Department of Immuno-Oncology, Kawasaki Medical School
Institute
Department

Funding Source
Organization	Kawasaki Medical School
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	IRB
Address	577 Matsushima, Kurashiki
Tel	086-462-1111
Email	kmsrec@med.kawasaki-m.ac.jp

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	川崎医科大学附属病院

Other administrative information
Date of disclosure of the study information	2017 Year 05 Month 22 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	10
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	No longer recruiting
Date of protocol fixation	2017 Year 04 Month 08 Day
Date of IRB	2017 Year 05 Month 08 Day
Anticipated trial start date	2017 Year 06 Month 01 Day
Last follow-up date	2018 Year 09 Month 30 Day
Date of closure to data entry	2018 Year 09 Month 30 Day
Date trial data considered complete	2018 Year 09 Month 30 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 10 Day
Last modified on	2020 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030429