UMIN-CTR Clinical Trial

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

Head and neck cancer, Ovarian cancer, Esophageal cancer, Multiple myeloma

Classification by specialty

Gastroenterology	Hematology and clinical oncology	Gastrointestinal surgery
Obstetrics and Gynecology	Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Adverse events

Key secondary outcomes

Antigen-specific immune responses

Study type

Interventional

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

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

Co-sponsor

Department of Surgery, Kitano Hospital
Department of Gastroenterology, Kyoto Prefectural University of Medicine

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2008

Year

03

Month

04

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2008

Year

03

Month

03

Day

Last modified on

2017

Year

04

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001284