UMIN-CTR Clinical Trial

Public title

CHP-MAGE-A4 vaccine study for MAGE-A4-expressing cancer

Acronym

CHP-MAGE-A4 vaccine study

Scientific Title

CHP-MAGE-A4 vaccine study for MAGE-A4-expressing cancer

Scientific Title:Acronym

CHP-MAGE-A4 vaccine study

Region

Japan

Condition

MAGE-A4-expressing therapy-resistant cancer (non origin-limited)

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Pneumology
Hematology and clinical oncology	Gastrointestinal surgery	Hepato-biliary-pancreatic surgery
Breast surgery	Obstetrics and Gynecology	Oto-rhino-laryngology
Urology	Oral surgery

Classification by malignancy

Malignancy

Genomic information

NO

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.

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Vaccine

Interventions/Control_1

Subcutaneous injection of CHP-MAGE-A4 protein complex vaccine 100 microgram or 300 microgram,every two weeks, repeated at least six cycles

Interventions/Control_2

Interventions/Control_3

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1.MAGE-A4-expressing therapy-resistant cancer, with clinical stage III or IV, recurrent, metastatic disease, or at high-risk if reccurrence.
2.histoligically confirmed malignant tumor
3.MAGE-A4-antigen expressing.
4.Performance status(ECOG) 0 to 2.
5.Aged twenty or more, male or female
6.At least four-month life expectancy
7.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.
8.Not willing to be pregnant (both sexes)
9.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

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, Edobashi, Tsu, Mie, 514-8507 Japan

TEL

059-231-5187

Email

kageyama@clin.medic.mie-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Shinichi Kageyama

Organization

CHP-MAGE-A4 clinical trial registry

Division name

Cancer vaccine, Mie Universituy

Zip code

Address

2-174, Edobashi, Tsu, Mie, 514-8507 Japan

TEL

059-231-5280

Homepage URL

Email

kageyama@clin.medic.mie-u.ac.jp

Institute

CHP-MAGE-A4 cancer vaccine study at Mie University

Institute

Department

Personal name

Organization

Mie University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2008

Year

12

Month

25

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.oncotarget.com/index.php?journal=oncotarget&page=article&op=view&path%5B%5D=26323&path%5B

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

10

Month

30

Day

Date of IRB

Anticipated trial start date

2008

Year

12

Month

01

Day

Last follow-up date

2012

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

12

Month

25

Day

Last modified on

2018

Year

12

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001877