UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Adoptive transfer of autologous T cells followed by vaccination with MAGE-A4-derived peptides after chemotherapy for MAGE-A4-expressing advanced cancer patients
Title of the study (Brief title)	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	Hiroshi Shiku
Organization	Mie University Graduate School of Medicine
Division name	Department of Immuno-gene Therapy
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	Shinichi Kageyama
Organization	Mie University Graduate School of Medicine
Division name	Department of Immuno-Gene Therapy
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 03 Month 03 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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