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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006704
Receipt No. R000007925
Scientific Title Phase I study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer
Date of disclosure of the study information 2011/11/14
Last modified on 2019/12/23

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Basic information
Public title Phase I study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer
Acronym Phase I study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer (DC5)
Scientific Title Phase I study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer
Scientific Title:Acronym Phase I study of Wilms' tumor gene WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer (DC5)
Region
Japan

Condition
Condition Advanced or recurrent esophageal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To assess the safety of the WT1 peptide pulsed dendritic cell vaccination combined with docetaxel for patients with advanced or recurrent esophageal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Advertise events
Key secondary outcomes Response rate
Progression free survival
Overall survival
Immune induction (Delayed type hypersensensitivity DTH for WT1 peptide)

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 Docetaxel 50 mg/m2/day day1
Dendritic cell day15,22
q4w , 3 cycle
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 1)Primary lesion is located at cervical or thoracic or abdominal esophagus
2)Histological diagnosis of esophageal cancer(adenocarcinoma or squamous cell carcinoma or adenosquamous carcinoma)
3)Patients with progressive disease treated by 5FU and cisplatin
4)Possess HLA-A2402
5)Obtains lesion that can be evaluated by RECIST
6)performance status (ECOG) 0,1,2
7) Adequate hematologic, hepatic, renal, and cardiac function
a)WBC >=3,000/mm3
b)Absolute neutrophil count 1,500/mm3
c)Platelet >=100,000/mm3
d)Hemoglobin >=9.0g/dL
e)AST and ALT <=100IU/L
f)Total bilirubin <1.5mg/dL
g)Creatinine <1.5mg/dL
h)ECG normal
8)Four weeks or more must pass from the prior treatment
9)Written informed consent
Edit
10)Previously treated-patient with 5-FU, cisplatin and/or docetaxel and/or radiotherapy.
Key exclusion criteria 1)Tracheo-esophageal fistula
2)Symptomatic brain metastasis
3)Active other primary malignancies
4)Past history of severe allergy
5)Severe comorbidity (infections, interstitial pneumonia, fibroid lung, cardiovascular disease, renal disease, liver disease, uncontrolled diabetes)
6)Pleural effusion or pericardial fluid requiring treatment
7)Pregnancy, nursing women
8)Male hope to impregnate
9)Severe psychiatric disease
10)Active autoimmune disease
11)During treatment with immunosuppressive agents
12)Patients whom doctors judged inadequate to the enrollment of this study by other reasons
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Kitagawa
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization School of Medicine, Keio University
Division name Department of Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL +813-5363-3802
Homepage URL
Email

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization Tella, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Midtown Medical Center
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
2011 Year 11 Month 14 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 Completed
Date of protocol fixation
2011 Year 10 Month 14 Day
Date of IRB
2011 Year 10 Month 20 Day
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2016 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 11 Month 11 Day
Last modified on
2019 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007925

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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