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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001680
Receipt No. R000002011
Scientific Title CHP-MAGE-A4 vaccine study for patients with advanced lung cancer
Date of disclosure of the study information 2009/03/01
Last modified on 2014/02/03

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Basic information
Public title CHP-MAGE-A4 vaccine study for patients with advanced lung cancer
Acronym CHP-MAGE-A4 vaccine study for lung cancer patients
Scientific Title CHP-MAGE-A4 vaccine study for patients with advanced lung cancer
Scientific Title:Acronym CHP-MAGE-A4 vaccine study for lung cancer patients
Region
Japan

Condition
Condition MAGE-A4-expressing therapy-resistant lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To see maximum-tolerable dose and give biological recommended dose by evaluating safety profiles and immune responses with repeated doses of CHP-MAGE-A4 vaccine in a dose-escalating study of 100 or 300 microgram in advanced lung cancer patients.
Basic objectives2 Others
Basic objectives -Others To evaulate tumor response, progression-free time, overall survival, response-duration time and time-to-progression
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Safety:maximum-tolerable dose, dose-limting toxicity, profiles of adverse events.
Efficacy: MAGE-A4-specific immune responses
Key secondary outcomes Efficacy:tumor responses, progression-free time, overall survival, response-duration time and time-to-progression

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine
Interventions/Control_1 Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 100 microgram,every week, repeated at least six cycles
Interventions/Control_2 Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 300 microgram,every week, repeated at least six cycles
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.MAGE-A4-expressing therapy-resistant lung cancer, with clinical stage III or IV, recurrent, metastatic disease, or at high-risk if reccurrence.
2.MAGE-A4-antigen expressing.
3.Performance status(ECOG) 0 to 2.
4.Aged twenty or more, male or female
5.At least four-month life expectancy
6.Normal major organ function, and meeting the criteria below
White cell counts 2,000/uL or more.
Hemoglobin 8.0 g/dl or more.
Platelets 75,000/uL or more.
Serum bilirubin: within 1.5 times of normal upper level(within 3 times in case of liver damage).
AST(GOT)/ALT(GPT): within 2.5 times of normal upper level(within 5 times in case of liver damage).
Serum creatinine within 1.5 times of normal upper level.
7.Not willing to be pregnant (both sexes)
8.Having written informed consent.
Key exclusion criteria 1.HIV-positives.
2.Double cancers.
3.Autoimmune disease.
4.History of serious hypersensitivity.
5.Active CNS metastasis.
6.Lasting less than four weeks from the previous chemotherapy, systemic corticostoroid, immuno-suppressive or -stimulating agents, radiotherapy, or surgery to primary tumors
7.Pregnant or lactating.
8.Inappropriate for study entry judged by an attending physician.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kosei Yasumoto
Organization University of Occupational and Environmental Health
Division name Second department of Surgery
Zip code
Address Yahatanishi Kitakyushu
TEL 093-691-7442
Email k-yasumo@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hanagiri Takeshi
Organization University of Occupational and Environmental Health
Division name Second department of Surgery
Zip code
Address 1-1 Iseigaoka, Yahatanishi, Kitakyushu
TEL 093-691-7442
Homepage URL
Email hanagiri@med.uoeh-u.ac.jp

Sponsor
Institute CHP-MAGE-A4 cancer vaccine study at University of Occupational and Environmental Health, Japan
Institute
Department

Funding Source
Organization University of Occupational and Environmental Health, Japan
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Cancer vaccine, Mie University
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
2009 Year 03 Month 01 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 No longer recruiting
Date of protocol fixation
2009 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 02 Month 02 Day
Last modified on
2014 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002011

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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