UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009607
Receipt number R000011266
Scientific Title The double-blind, randomised controlled phase II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with head and neck mucosal melanoma followed by standard therapy.
Date of disclosure of the study information 2013/04/01
Last modified on 2020/08/15 14:17:19

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Basic information

Public title

The double-blind, randomised controlled phase II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with head and neck mucosal melanoma followed by standard therapy.

Acronym

Chiba NKT therapy for HNSCC

Scientific Title

The double-blind, randomised controlled phase II study of the adjuvant therapy using alpha-galactosylceramide pulsed antigen presenting cells for patients with head and neck mucosal melanoma followed by standard therapy.

Scientific Title:Acronym

Chiba NKT therapy for HNSCC

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

To assess the efficacy of alpha-galactosylceramide pulsed antigen presenting cells as an adjuvant therapy for the patients with head and neck squamous cell carcinoma followed by a standard therapy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Recurrence-free survival

Key secondary outcomes

Two-year recurrence-free survival
Two-year overall survival
Evaluation of NKT cell specific immune response
Safety profile


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

The injections of 100 million of alpha-GalCer pulsed APCs on day 7 and 10 into nasal submucosa.

Interventions/Control_2

The injections of 100 million of untreated APCs on day 7 and 14 into nasal submucosa.

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

Stage IV HNSCC; Complete responce (CR) after first standard therapy; Within 8 weeks after the assessment of CR; Within 4 months after previous treatment; pathological diagnosis of squamous cell carcinoma; Performance status is 0 - 2; Normal bone marrow, liver and renal 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, judgement of physician

Target sample size

66


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Okamoto

Organization

Chiba University Hospital

Division name

Department of Otorhinolaryngology, Head and Neck Surgery

Zip code


Address

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

TEL

043-222-7171

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/en/index.html

Email



Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Chiba University Hospital

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 01 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

Terminated

Date of protocol fixation

2012 Year 12 Month 21 Day

Date of IRB

2013 Year 04 Month 01 Day

Anticipated trial start date

2013 Year 04 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 12 Month 21 Day

Last modified on

2020 Year 08 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011266


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name