UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005706
Receipt number R000006748
Scientific Title Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients
Date of disclosure of the study information 2011/06/10
Last modified on 2011/06/02 12:06:36

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Basic information

Public title

Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients

Acronym

Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients

Scientific Title

Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients

Scientific Title:Acronym

Multicenter clinical trial of Percutaneous Peptide Immunization for malignant melanoma patients

Region

Japan


Condition

Condition

malignant melanoma

Classification by specialty

Dermatology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effectiveness and safety of the percutaneous peptide immunization

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Overall survival by status of tumor specific cytotoxic T cell induction

Key secondary outcomes

Induction rate of tumor specific cytotoxic T cell.
Tumor regression
Adverse events


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

Other

Interventions/Control_1

Percutaneous immunization

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

Patients with malignant melanoma. HLA-A0201 or HLA-A2402 positive patient.

Key exclusion criteria

Not received chemo therapy within a month. No big metastatic lesion in the liver or in the brain. Not pregnant. Not receiving immunosuppressive agent.
No eczematous lesion on the skin. No hepatitis. No collagen disease.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Toshiharu Fujiyama

Organization

Hamamatsu University School of Medicine

Division name

Department of Dermatology

Zip code


Address

1-20-1 Handayama Higashi-ku Hamamatsu Shizuoka, Japan

TEL

053-435-2303

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Hamamatsu University School of Medicine

Division name

Department of Dermatology

Zip code


Address

1-20-1 Handayama Higashi-ku Hamamatsu Shizuoka, Japan

TEL

053-435-2303

Homepage URL


Email



Sponsor or person

Institute

Hamamatsu University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan society for the promotion of science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Osaka city University, Imayama Syuhei clinic and labo, Shirai dermatology clinic, Aichi Cancer Center

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



Other administrative information

Date of disclosure of the study information

2011 Year 06 Month 10 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

2003 Year 01 Month 01 Day

Date of IRB


Anticipated trial start date

2003 Year 06 Month 01 Day

Last follow-up date

2011 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2011 Year 06 Month 02 Day

Last modified on

2011 Year 06 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006748


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name