UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study of WT-1 pulsed dendritic cell immunotherapy as a 2nd line treatment for patients with advanced/recurrent thymic carcinoma.
Title of the study (Brief title)	Phase II study of WT-1 pulsed dendritic cell immunotherapy for patients with thymic carcinoma.
Region	Japan

Condition
Condition	Thymic carcinoma
Classification by specialty	Pneumology Chest surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Objective of this exploratory study is to investigate efficacy and safety of WT-1 pulsed dendritic cell immunotherapy as a 2nd line treatment for patients with advanced/recurrent thymic carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	progression free survival
Key secondary outcomes	overall survival(OS), response rate, delayed type hypersensitivity, ELISPOT assay, tetramer assay

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	Vaccine
Interventions/Control_1	WT-1 pulsed dendritic cell immunotherapy
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients with advanced/recurrent thymic carcinoma who have previously been treated with at least one chemotherapy regimen 2) Aged 20 to 75 years 3) Performance status (ECOG) 0-1 4) Patients don't have been joined any other trials 5) Patients providing written informed consent 6) Adequate organ function 7) HBV Ag, HCV Ag, HTLV1, HIV, syphilis negative 8) Patients who have one of the following HLA types: A2402, A0201, A0206
Key exclusion criteria	1) Patients with active concomitant malignancy 2) Patients have allergy for OK-432 or penicillin 3) With uncontrollable hypertension or diabetes 4) With angina pectoris or myocardial infarction 5) With uncontrollable heart failure or cerebrovascular disorder 6) With pulmonary fibrosis or interstitial pneumonia 7) With bleeding ulcer, intestinal obstruction 8) With Immunosuppressive agent or predonine 9) With severe allergy disease 10) With autoimmune disease 11) With myelodysplastic syndrome 12) Pregnancy or lactation. 13) Patients with mental disorder, and considered as inappropriate for the study by the physicians 14) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	25

Research contact person
Name of lead principal investigator	Hiroyuki Suzuki
Organization	Fukushima Medical University
Division name	Chest Surgery
Address	Hikarigaoka 1 Fukushima, JAPAN
TEL	024-547-1111
Email	hiro@fmu.ac.jp

Public contact
Name of contact person	Hiroyuki Suzuki
Organization	Fukushima Medical University
Division name	Chest Surgery
Address	Hikarigaoka 1 Fukushima, JAPAN
TEL	024-547-1111
Homepage URL
Email	hiro@fmu.ac.jp

Sponsor
Institute	Fukushima Medical University
Institute
Department

Funding Source
Organization	Chest surgery, Fukushima Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2016 Year 09 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 01 Month 31 Day
Anticipated trial start date	2017 Year 08 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2016 Year 08 Month 08 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026893