UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008380
Receipt number R000009852
Scientific Title A clinical study of cancer peptides vaccine therapy in the patients who have recieved surgical resection and had no residual tumor for head and neck cancer
Date of disclosure of the study information 2012/07/08
Last modified on 2012/07/08 21:38:13

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Basic information

Public title

A clinical study of cancer peptides vaccine therapy in the patients who have recieved surgical resection and had no residual tumor for head and neck cancer

Acronym

A clinical study of adjuvant peptides vaccine therapy after surgical resection of head and neck cancer

Scientific Title

A clinical study of cancer peptides vaccine therapy in the patients who have recieved surgical resection and had no residual tumor for head and neck cancer

Scientific Title:Acronym

A clinical study of adjuvant peptides vaccine therapy after surgical resection of head and neck cancer

Region

Japan


Condition

Condition

head and neck cancer

Classification by specialty

Dental medicine

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

Conformation of safty and efficacy of adjuvant peptides vaccine therapy for head and neck cancer using peptides in the patients who have recieved surgical resection and had no tumor.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II


Assessment

Primary outcomes

safty

Key secondary outcomes

immunological response and clinical efficacy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Vaccine

Interventions/Control_1

peptides vaccine therapy using URLC10, CDCA1, and KOC1-targeted peptides in the patients who have recieved surgical resection and had no tumor of head and neck cancer

Interventions/Control_2

no peptides vaccine therapy

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

16 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients who have no treatment against oral cancer.
2. Performance status of patients are 0-2.
3. more than 20, less than 85 years of age.
4. At least 4 weeks past after the patient has received last treatment.
5. Has adequate organ function as difined by following criteria.
1) WBC count more than 2000/mm3, less than 25000/mm3
2) Plt count more than 50000/mm3
3) AST and ALT less than 150IU/L
4) T.Bil less than 3.0mg/dl
5) Cr less than 3.0mg/dl
6) Patients who have HLA-A*2402.
7) All patients gave written informed consent.

Key exclusion criteria

1. Pregnancy or lactation.
2. Patients who are treated with steroid or immunotherapy during clinical trial.
3. Patients have uncontrollable associated cancer.
4. Patients who are not agree.
5. Patients who are inappropriate.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masanori Shinohara

Organization

Graduated school of medicine Kumamoto University

Division name

Department of Oral and Maxillofacial surgery

Zip code


Address

1-1-1 Honjo, Kumamoto city, Kumamoto 860-8556, Japan

TEL

096-373-5288

Email



Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Yoshitake

Organization

Graduated school of medicine Kumamoto University

Division name

Department of Oral and Maxillofacial surgery

Zip code


Address

1-1-1 Honjo, Kumamoto city, Kumamoto 860-8556, Japan

TEL

096-373-5288

Homepage URL


Email



Sponsor or person

Institute

Department of Oral and Maxillofacial surgery, Graduated school of medicine Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

Department of Oral and Maxillofacial surgery, Graduated school of medicine Kumamoto University

Organization

Division

Category of Funding Organization

Self funding

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

2012 Year 07 Month 08 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

Open public recruiting

Date of protocol fixation

2010 Year 06 Month 11 Day

Date of IRB


Anticipated trial start date

2010 Year 10 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



Management information

Registered date

2012 Year 07 Month 08 Day

Last modified on

2012 Year 07 Month 08 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009852


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name