UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000722
Receipt number R000000858
Scientific Title Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer
Date of disclosure of the study information 2007/06/30
Last modified on 2008/05/24 12:07:22

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Basic information

Public title

Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer

Acronym

Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer

Scientific Title

Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer

Scientific Title:Acronym

Clinical study of alpha-GalactosylCeramide-pulsed dendritic cells and natural killer T (NKT) cells in patients with head and neck cancer

Region

Japan


Condition

Condition

Head and neck squamous cell carcinoma

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The feasibility of alpha-GalactosylCeramide-pulsed dendritic cell and natural killer T (NKT) cell immunotherapy in patients with head and neck squamous cell carcinoma are examined. The immunological responses and anti-tumor effects are also investigated.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I,II


Assessment

Primary outcomes

Immunological response

Key secondary outcomes

Safety, Clinical response


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

Medicine Maneuver

Interventions/Control_1

In the patients with distant metastasis, intra-venous and sub-mucosal injections of alpha-GalactosylCeramide pulsed DCs are performed at 1, 2, 7 and 8 weeks after the entry. In the patients with local recurrence, sub-mucosal injections of alpha-GalactosylCeramide pulsed DCs are performed on day 7 and 13, and activated NKT cells is infused intra-arterially on day 14 after the entry.

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Head and neck squamous cell carcinoma patients who have measurable lesion Patients whose life-expectancy is more than 6 months Performance status 0-1 Normal bone marrow, liver and renal functions NKT cells are detected at least 10 cells in 1 mL of peripheral blood and expanded more than 100 times in vitro.

Key exclusion criteria

Patients who have: been treated with previous therapy of at least 4 weeks; uncontrolled diabetes mellitus, interstitial pneumonia, pleural effusion, ascites and/or pericardial effusion; a history of hepatitis; a positive response for hepatitis B surface antigen, or human immunodeficiency virus (HIV), hepatitis C virus, or human T-lymphotrophic virus antibodies; other cancers; serious cardiac disease; recieived concurrent corticosteroid therapy; pregnancy or lactation; autoimmune diseases; been judged to be inappropriate to participate in this study by principle investigator or co-investigator.

Target sample size

14


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 Otorhinolaryngology, Head and Neck Surgery

Zip code


Address

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

TEL

043-226-2137

Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Graduate School of Medicine, Chiba University

Division name

Department of Otorhinolaryngology, Head and Neck Surgery

Zip code


Address

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

TEL

043-226-2137

Homepage URL


Email



Sponsor or person

Institute

Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University

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



Other administrative information

Date of disclosure of the study information

2007 Year 06 Month 30 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

2005 Year 05 Month 09 Day

Date of IRB


Anticipated trial start date

2005 Year 07 Month 01 Day

Last follow-up date

2007 Year 06 Month 01 Day

Date of closure to data entry

2007 Year 10 Month 01 Day

Date trial data considered complete

2007 Year 10 Month 01 Day

Date analysis concluded

2007 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 05 Month 23 Day

Last modified on

2008 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000858


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name