UMIN-CTR Clinical Trial

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