UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001680 |
|---|---|
| Receipt number | 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 07:55:59 |
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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
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
hanagiri@med.uoeh-u.ac.jp
Sponsor or person
Institute
CHP-MAGE-A4 cancer vaccine study at University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002011
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| Registered date | File name |
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| Registered date | File name |
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