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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002395
Receipt No. R000002761
Scientific Title Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene for therapy-resistant esophageal cancer
Date of disclosure of the study information 2009/08/28
Last modified on 2015/05/20

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Basic information
Public title Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene for therapy-resistant esophageal cancer
Acronym Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene
Scientific Title Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene for therapy-resistant esophageal cancer
Scientific Title:Acronym Adoptive transfer of lymphocytes transduced with MAGE-A4-specific TCR gene
Region
Japan

Condition
Condition Therapy-resistant esophageal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety, kinetics and clinical responses after trasnfer of autologous lymphocytes tranduced with TCR-alpha/beta gene recognizing MAGE-A4-peptide
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes # Safety; adverse events, including laboratory data and replication competent retrovirus(RCR)/linear amplification mediated-PCR(LAM-PCR)
Key secondary outcomes # Kinetics and tumor infiltration of TCR/gene-transduced lymphocytes
# Tumor-specific immune responses
# Tumor shrinkage

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 3
Purpose of intervention Treatment
Type of intervention
Medicine Gene
Interventions/Control_1 First cohort; three patinets
1.TCR-gene-transduced autologous lymphocytes infusion
2x10*8 cells, single dose, IV
2. MAGE-A4 peptide administration
300 micrograms, mixed with Montanide(incomplete Freund's adjuvant), SQ, on day 14 and 28 after lymphocytes infusion
Interventions/Control_2 Second cohort; three patinets
1.TCR-gene-transduced autologous lymphocytes infusion
1x10*9 cells, single dose, IV
2. MAGE-A4 peptide administration
300 micrograms, mixed with Montanide(incomplete Freund's adjuvant), SQ, on day 14 and 28 after lymphocytes infusion
Interventions/Control_3 Third cohort; three patinets
1.TCR-gene-transduced autologous lymphocytes infusion
5x10*9 cells, single dose, IV
2. MAGE-A4 peptide administration
300 micrograms, mixed with Montanide(incomplete Freund's adjuvant), SQ, on day 14 and 28 after lymphocytes infusion
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1.Histologically-confirmed malignant esophageal tumor
2.Therapy-resistant cancer, including chemotherapy and radiotherapy, with clinical stage III or IV, recurrent, and metastatic disease
3.HLA-A2402-positive
4.PCR or immunohistochemistry-confirmed MAGE-A4-antigen expression of tumor cells
5.Having measurable tumor for assessing clinical responses
6.Performance status(ECOG) 0 to 1]
7.Aged 20 to 75 years
8.Recovery lasting after the previous therapy, including surgery, chemotherapy and radiotherapy
9.At least four-month life expectancy
10.Normal major organ function, and meeting the criteria below
# White cell counts 3,000/uL or more
# Neutrophils 1,500/uL or more
# Hemoglobin 8.0 g/dL or more
# Platelets 100,000/uL or more.
# Serum total bilirubin 2.0mg/dL or less
# AST(GOT)/ALT(GPT) 150IU/dL or less
# Serum creatinine 2.0mg/dL or less
# Aterial oxygen pressure 70 torr or more, or oxygen saturation 94% or more
11.Positive for HLA class I molecule on tumor cells
12.Having written informed consent
Key exclusion criteria 1.Having following serious complications
# Uncontrolled anigina pectoris, myocardial infarction, or heart failure
# Uncontrolled diabetes mellitus or hytertention
# Uncontrolled infection
# X-ray-proven interstitial pneumonia or pulmonary fibrosis
# Autoimmune disease
# Bleeding tendency; PT less than 50%, APTT more than 60sec, serum fibrinogen less than 100mg/dL, FDP more than 20ug/mL
Thrombosis tendency
2.History of serious hypersensitivity
3.Positive for HBs Ag, HCV Ab, HIV Ab, or HTLV-I Ab
4. Unctrolled pleural effusion, ascites, or pericardial effusion
5.Uncontrolled CNS metastasis
6.Systemic corticostoroid or immuno-suppressive therapy
7. Inappropriate for MAGE-A4 143-151 peptide administration, i.e. allergic to the peptide or adjuvant
8.Mental illness or drug dependency affecting informed consent
9.Pregnant, lactating, or possiblly pregnant women, or willing to be pregnant, or willing male partner, except having cryopreseved sperm
10. Lasting less than four weeks from the previous enrollment to clinical trials
11.Inappropriate for study entry judged by an attending physician.
Target sample size 9

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Shiku
Organization Mie University Graduate School of Medicine
Division name Immuno-Gene Therapy
Zip code
Address 2-174, Ebobashi, Tsu, Mie, 514-8507 Japan
TEL 059-231-5187
Email shiku@clin.medic.mie-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Kageyama
Organization Mie University Graduate School of Medicine
Division name Immuno-Gene Therapy
Zip code
Address 81-59-231-5187
TEL 059-231-5187
Homepage URL
Email kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute Mie University Hospital
Institute
Department

Funding Source
Organization Mie University
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Takara Bio Incorporation
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 三重大学医学部附属病院(三重県)

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://clincancerres.aacrjournals.org/content/21/10/2268.full
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 Completed
Date of protocol fixation
2009 Year 08 Month 19 Day
Date of IRB
Anticipated trial start date
2009 Year 08 Month 01 Day
Last follow-up date
2013 Year 04 Month 30 Day
Date of closure to data entry
2014 Year 02 Month 10 Day
Date trial data considered complete
2014 Year 02 Month 10 Day
Date analysis concluded
2014 Year 02 Month 10 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 28 Day
Last modified on
2015 Year 05 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002761

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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