UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023543 |
|---|---|
| Receipt number | R000026893 |
| Scientific Title | Exploratory study of WT-1 pulsed dendritic cell immunotherapy as a 2nd line treatment for patients with advanced/recurrent thymic carcinoma. |
| Date of disclosure of the study information | 2016/09/01 |
| Last modified on | 2018/03/01 20:01:13 |
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Basic information
Public title
Exploratory study of WT-1 pulsed dendritic cell immunotherapy as a 2nd line treatment for patients with advanced/recurrent thymic carcinoma.
Acronym
Phase II study of WT-1 pulsed dendritic cell immunotherapy for patients with thymic carcinoma.
Scientific Title
Exploratory study of WT-1 pulsed dendritic cell immunotherapy as a 2nd line treatment for patients with advanced/recurrent thymic carcinoma.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Suzuki |
Organization
Fukushima Medical University
Division name
Chest Surgery
Zip code
Address
Hikarigaoka 1 Fukushima, JAPAN
TEL
024-547-1111
hiro@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Suzuki |
Organization
Fukushima Medical University
Division name
Chest Surgery
Zip code
Address
Hikarigaoka 1 Fukushima, JAPAN
TEL
024-547-1111
Homepage URL
hiro@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2017 | Year | 01 | Month | 31 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026893
