UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000008006
Receipt number	R000009416
Scientific Title	Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid tumor.
Date of disclosure of the study information	2012/05/21
Last modified on	2018/01/12 18:00:24

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Basic information

Public title

Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid tumor.

Acronym

Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid Tumor.

Scientific Title

Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid tumor.

Scientific Title:Acronym

Phase I Clinical Study on the Long-term Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Solid Tumor.

Region

Japan

Condition

Refractory Solid Tumor

Classification by specialty

Hematology and clinical oncology Urology

Classification by malignancy

Malignancy

Genomic information

Objectives

Narrative objectives1

To evaluate the adverse effect and immune response in patients with NY-ESO-1-expressing refractory solid tumor treated long-term with the CHP-NY-ESO-1 cancer vaccine and the immunological adjuvant MIS416.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase I

Assessment

Primary outcomes

Adverse effects.

Key secondary outcomes

Immune response, QOL, and the change in serum PSA (prostate cancer only).

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

CHP-NY-ESO-1, MIS416

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

Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Completion of the study 'Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Urothelial or Prostate Cancer' or 'Phase I Study on the Combination Therapy of IMF-001 and MIS416 for the Treatment of Patients with NY-ESO-1-expressing malignant solid tumor'.
2) Non-progressive disease on the study termination image test of 'Phase I Clinical Study on the Combination Therapy of CHP-NY-ESO-1 Cancer Vaccine and MIS416 for the Treatment of Patients with NY-ESO-1-expressing Refractory Urothelial or Prostate Cancer' or 'Phase I Study on the Combination Therapy of IMF-001 and MIS416 for the Treatment of Patients with NY-ESO-1-expressing malignant solid tumor'.
3) Cooperativeness to written informed consent must be obtained and documented.

Key exclusion criteria

None

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Yoshiki Sugimura

Organization

Mie University Graduate School of Medicine

Division name

Dep. of Nephro-Urologic Surgery and Andrology

Zip code

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

Email

Public contact

Name of contact person

1st name

Middle name

Last name

Organization

Mie University Graduate School of Medicine

Division name

Dep. of Cancer Vaccine / Immuno-Gene Therapy Study Secretariat

Zip code

Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

059-231-5684

Homepage URL

http://www.shikuken.jp/

Email

cv-adm@doc.medic.mie-u.ac.jp

Sponsor or person

Institute

Mie University Graduate School of Medicine

Institute

Department

Personal name

Funding Source

Organization

Foundation

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

2012 Year 05 Month 21 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

2010 Year 12 Month 18 Day

Date of IRB

Anticipated trial start date

2012 Year 05 Month 01 Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Management information

Registered date

2012 Year 05 Month 21 Day

Last modified on

2018 Year 01 Month 12 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009416

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name