UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006704 |
|---|---|
| Receipt number | 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 09:48:20 |
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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
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
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007925
