UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009447
Receipt number R000011099
Scientific Title Clinical prospective study to investigate efficacy of WT1 peptide (PepTivator(R))-pulsed dendritic cell vaccination therapy
Date of disclosure of the study information 2012/12/01
Last modified on 2014/12/04 11:13:50

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Basic information

Public title

Clinical prospective study to investigate efficacy of WT1 peptide (PepTivator(R))-pulsed dendritic cell vaccination therapy

Acronym

Clinical prospective study to investigate efficacy of WT1 peptide (PepTivator(R))-pulsed dendritic cell vaccination therapy

Scientific Title

Clinical prospective study to investigate efficacy of WT1 peptide (PepTivator(R))-pulsed dendritic cell vaccination therapy

Scientific Title:Acronym

Clinical prospective study to investigate efficacy of WT1 peptide (PepTivator(R))-pulsed dendritic cell vaccination therapy

Region

Japan


Condition

Condition

Malignant tumor (all HLA types)

Classification by specialty

Medicine in general Gastroenterology Hepato-biliary-pancreatic medicine
Cardiology Pneumology Endocrinology and Metabolism
Hematology and clinical oncology Nephrology Surgery in general
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery
Chest surgery Endocrine surgery Breast surgery
Obstetrics and Gynecology Dermatology Oto-rhino-laryngology
Urology Oral surgery Neurosurgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy of WT1 peptide (PepTivator(R))-pulsed dendritic cell vaccination therapy for malignant tumors.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Immunological responses

Key secondary outcomes

Safety
Efficacy


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

1

Purpose of intervention

Treatment

Type of intervention

Vaccine Maneuver

Interventions/Control_1

WT1 peptide(PepTivator(R))-pulsed dendritic cells are injected on day0, day14, day28, day42, day56, day70

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)Patients with histologically confirmed malignant tumors (all HLA types)
(2)Patients who recognized WT1 expression on tumor tissue
(3)Performance Status is 0-2
(4)No serious abnormality in bone marrow, liver, and renal functions
(5)Informed consent has been obtained.

Key exclusion criteria

Patients who have:
(1)Pulmonary fibrosis or interstitial pneumonia, or history or predisposition of them
(2)Serious drug allergy
(3)Positive for HIV or HTLV-1
(4)Active autoimmune disease
(5)Continuous systemic administration of steroids
(6)Other cancers
(7)Active infections
(8)Pregnant or lactating
(9)Serious cardiac disease
(10)Any reason why, in the opinion of the investigator, the patient should not participate.

Target sample size

5


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Kamigaki

Organization

Seta Clinic Group

Division name

Clinical research center

Zip code


Address

Iidabashi 3-6-5 Kokoro to karada no genki plaza 8F, Chiyoda, Tokyo, 102-0072, Japan

TEL

03-5215-0086

Email



Public contact

Name of contact person

1st name
Middle name
Last name Hiroshi Ibe

Organization

Seta Clinic Group

Division name

Clinical research center

Zip code


Address

Iidabashi 3-6-5 Kokoro to karada no genki plaza 8F, Chiyoda, Tokyo, 102-0072, Japan

TEL

03-5215-0086

Homepage URL


Email

scrc@j-immunother.com


Sponsor or person

Institute

Seta Clinic Group

Institute

Department

Personal name



Funding Source

Organization

Medinet Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

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

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

瀬田クリニックグループ


Other administrative information

Date of disclosure of the study information

2012 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2012 Year 09 Month 03 Day

Date of IRB


Anticipated trial start date

2012 Year 12 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

AACR 2014/American Asociation for Cancer Research 2014
ISCT 2014/International Society for Cellular Therapy 2014


Management information

Registered date

2012 Year 11 Month 30 Day

Last modified on

2014 Year 12 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011099


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name