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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001063
Receipt No. R000001284
Scientific Title Adoptive transfer of autologous T cells followed by vaccination with MAGE-A4-derived peptides after chemotherapy for MAGE-A4-expressing advanced cancer patients
Date of disclosure of the study information 2008/03/04
Last modified on 2017/04/20

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Basic information
Public title Adoptive transfer of autologous T cells followed by vaccination with MAGE-A4-derived peptides after chemotherapy for MAGE-A4-expressing advanced cancer patients
Acronym Adoptive T cell transfer therapy with MAGE-A4 peptide vaccination
Scientific Title Adoptive transfer of autologous T cells followed by vaccination with MAGE-A4-derived peptides after chemotherapy for MAGE-A4-expressing advanced cancer patients
Scientific Title:Acronym Adoptive T cell transfer therapy with MAGE-A4 peptide vaccination
Region
Japan

Condition
Condition Head and neck cancer, Ovarian cancer, Esophageal cancer, Multiple myeloma
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Obsterics and gynecology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate adverse events following adoptive T cell transfer and MAGE-A4 peptide vaccination after chemotherapy for advanced ovary, head and neck and esophagus cancers and multiple myeloma
Basic objectives2 Others
Basic objectives -Others To evaluate specific immune responses to MAGE-A4 and other expressing tumor antigens
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Adverse events
Key secondary outcomes Antigen-specific immune responses

Base
Study type Interventional

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

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Vaccine Maneuver
Interventions/Control_1 Chemotherapy, three cycles
cisplatinum/5FU for head/neck and esophageal cancers
paclitaxel/carboplatin for ovarian cancera
vincristine/doxorubicin/dexamethazone for multiple myeloma
Interventions/Control_2 Intravenous transfer of autologous T cells after the second and third cycle of chemotherapy.
Dose-escalation study with three groups
1x10*9 cells 3 patients
3x10*9 cells 3 patients
9x10*9 cells 3 patients
Interventions/Control_3 Subcutaneous MAGE-A4 peptide injection, after
T cell transfer
sigle dose of 300microgrms
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)Either of the following disease
a)Epidermal ovarian carcinoma with recurrence or residual disease after standard treatment or unresectable recurrence, being planned to receive at least three cycles of TJ(Taxol/Carboplatin) therapy.
b)Head and neck squamous cell carcinoma with recurrence not having curative treatment options, residual disease after standard therapy, or patients refusal of surgical treatment, being planned to receive at least three cycles of chemotherapy.
c)Esophageal carinoma with recurrence after standard therapy or primary unmanageable disease.
d)Multiple myeloma with recurrence or primary therapy-resistance.
2)Positive for MAGE-A4 antigen and at least one of NY-ESO-1, WT-1, MAGE-A3 and SAGE antigens on tumor cells.
3)Positive HLA-type for A2402 or A0201.
4)Aged from 20 to 75 years.
5)Grade 0 to 2 in performance status(ECOG).
6)Lasting at least four weeks since the previous chemotherapy or radiotherapy, or two weeks since the previous anti-metabolites.
7)No major organ dysfunctions, including bone marrow, heart, lung, liver, and kidney, which meet the following criteria
For head/neck, esophageal and ovarian cancers
WBC 3,000/mm3 or more
Neutrophils 1,500/mm3 or more
Platelets 10x103/mm3 or more
Hb 9.0/dL or more
AST(GOT), ALT(GPT) 100 IU/L or less
Total bilirubin 2.0 mg/dL or less
Serum creatinine 1.5 mg/dL or less
For multiple myeloma
AST(GOT), ALT(GPT) within three times of normal upper range
Total bilirubin 2.0 mg/dL or less
Serum creatinine within three times of normal upper range
8) Having tolerable function of bone marrow, liver and kidneys for chemotherapy being used in the study.
9) Able to be followed with safety and immune response profiles throughout the study.
10) Expected to be alive at least three months after informed consent.
11) Full understanding of the study and voluntary agreement with written informed consent.
Key exclusion criteria 1)Positive either for HIV, HBV, HCV or HTLV-1
2)Allergic for agents used in this study, or prior allergic reactions requiring treatments
3)Notable fluid retention, including pleural effusion, ascites, or pericardial effusion.
4)Brain metastasis manifesting clinical signs and symptoms
5)Active infection
6)Unstable angina pectoris, history of myocardial infarction less than six months prior, or serious arrhythmia requiring treatments.
7)Interstitional pneumonia or pulmonary fibrosis
8)History of widespread bone marrow irradiation.
9)Paralysis or obstruction of gastrointestinal tracts.
10)Active double cancers occurring within five years, except lesions of "carcinoma in situ" or intramucosal location which are curatively resectable.
11)Uncontrolled diabetes mellitus
12)Women who are pregnant, milking , possibly pregnant, or refuse anticonception.
13)Judged as inappropriate for the study entry by the principle investigator or physicians responsible for the study.
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 Department of Immuno-gene Therapy
Zip code
Address 2-174, Edobashi, 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 Department of Immuno-Gene Therapy
Zip code
Address 2-174, Edobashi, Tsu, Mie, 514-8507 Japan
TEL 059-231-5187
Homepage URL http://www.shikuken.jp/
Email kageyama@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Immuno-gene Therapy, Mie University Graduate School of Medicine
Takara Bio
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Surgery, Kitano Hospital
Department of Gastroenterology, Kyoto Prefectural University of Medicine
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 三重大学病院(三重県)、北野病院(大阪府)、京都府立医科大学病院(京都府)

Other administrative information
Date of disclosure of the study information
2008 Year 03 Month 04 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 Completed
Date of protocol fixation
2008 Year 03 Month 03 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 03 Day
Last follow-up date
2010 Year 03 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
2008 Year 03 Month 03 Day
Last modified on
2017 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001284

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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