UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011508
Receipt number R000013468
Scientific Title The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma
Date of disclosure of the study information 2013/08/18
Last modified on 2015/03/17 21:44:59

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Basic information

Public title

The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma

Acronym

The phase I study with alpha-GalCer pulsed APCs and tumor peptide pulsed DCs for head and neck mucosal melanoma

Scientific Title

The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma

Scientific Title:Acronym

The phase I study with alpha-GalCer pulsed APCs and tumor peptide pulsed DCs for head and neck mucosal melanoma

Region

Japan


Condition

Condition

Head and neck mucosal malignant melanoma

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the feasibility of the combined immuntherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for the patients with advanced head and neck mucosal malignant melanoma.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety profile

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

expanded access

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

The injections of 100 millions of alpha-GalCer pulsed APCs and 0.5 millions of peptide pulsed DCs on day 7 into nasal submucosa.

Interventions/Control_2

The injections of 100 millions of alpha-GalCer pulsed APCs and 1 millions of peptide pulsed DCs on day 7 into nasal submucosa.

Interventions/Control_3

The injections of 100 millions of alpha-GalCer pulsed APCs and 5 millions of peptide pulsed DCs on day 7 into nasal submucosa.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Advanced head and neck mucosal malignant melanoma; untreatable; HLA-A*2402 positive; pathological diagnosis of melanoma; ; Performance status is 0-2; Normal bone marrow and liver functions; written informed concent

Key exclusion criteria

Past histry of hepatitis; a positive response for HBs antigen/HCT antibody/HIV antibody/HTL-V1 antibody; recieived concurrent corticosteroid therapy; pregnancy or lactation; antoimmune disease; infection; uncontrolled diabetes mellitus; pulmonary fibrosis; serious cardiac disease; double cancer; large pleural effusions: brain metastasis judgement of physician

Target sample size

9


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Okamoto

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Otorynolaryngology, Head and Neck Surgery

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Chiba University Hospital

Division name

Center for Advanced Medicine

Zip code


Address


TEL


Homepage URL

http://www.ho.chiba-u.ac.jp/future/

Email



Sponsor or person

Institute

Department of Otorynolaryngology, Head and Neck Surgery

Institute

Department

Personal name



Funding Source

Organization

The Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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

千葉大学医学部附属病院(千葉県)


Other administrative information

Date of disclosure of the study information

2013 Year 08 Month 18 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

2013 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2013 Year 08 Month 19 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

2013 Year 08 Month 18 Day

Last modified on

2015 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013468


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name