UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026493 |
|---|---|
| Receipt number | R000030429 |
| Scientific Title | Phase I study safety and immunogenicity of vaccination with XAGE1 long peptides in patients with advanced lung adenocarcinoma |
| Date of disclosure of the study information | 2017/05/22 |
| Last modified on | 2020/03/13 00:52:03 |
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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
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
kuro-ko.66@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Department of Immuno-Oncology, Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030429
