UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of alpha-GalactosylCeramide-pulsed DC therapy in Patients with Head and Neck Malignant Melanoma after the Charged Particle Radiotherapy
Title of the study (Brief title)	Clinical study of alpha-GalactosylCeramide-pulsed DC therapy
Region	Japan

Condition
Condition	Head and Neck Malignant Melanoma
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The feasibility of alpha-GalactosylCeramide-pulsed dendritic cell immunotherapy in patients with head and neck malignant melanoma are examined. The safety, clinical effects and immunological responses are investigated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Safety
Key secondary outcomes	The clinical effects and immunological responses

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Sub-mucosal administrations of alpha-GalactosylCeramide pulsed DCs are performed on day 7, 14, 56 and day63 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	Patients with head and neck malignant melanoma, who have received with the Charged Particle Radiotherapy and DAV(DITC, ACNU, VCR)-Chemotherapy; Patients whose life-expectancy is more than 6 months; Performance status 0-2; Normal bone marrow, liver and renal functions; NKT cells are detected at least 10 cells in 1 mL of peripheral blood.
Key exclusion criteria	Patients who have: uncontrolled diabetes mellitus, pulmonary fibrosis, and/or infection; 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; 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	20

Research contact person
Name of lead principal investigator	Yoshitaka Okamoto
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Otorhinolaryngology, Head and Neck Surgery
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
Email

Public contact
Name of contact person	Shigetoshi Horiguchi
Organization	Graduate School of Medicine, Chiba University
Division name	epartment of Otorhinolaryngology, Head and Neck Surgery
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
Homepage URL
Email

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

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	National Institute of Radiological Sciences
Name of secondary funｄer(s)

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	2009 Year 05 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 08 Month 01 Day
Anticipated trial start date	2008 Year 04 Month 01 Day
Last follow-up date	2012 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2009 Year 05 Month 01 Day
Last modified on	2019 Year 03 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002294