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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000005226
Receipt No. R000006211
Scientific Title Phase I study of Wilms' tumor gene WT1 peptide vaccination combined with gemcitabine for patients with advanced non-small-cell lung cancer
Date of disclosure of the study information 2011/03/10
Last modified on 2011/09/09

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Basic information
Public title Phase I study of Wilms' tumor gene WT1 peptide vaccination combined with gemcitabine for patients with advanced non-small-cell lung cancer
Acronym Phase I study of Wilms' tumor gene WT1 peptide vaccination combined with gemcitabine for patients with advanced non-small-cell lung cancer
Scientific Title Phase I study of Wilms' tumor gene WT1 peptide vaccination combined with gemcitabine for patients with advanced non-small-cell lung cancer
Scientific Title:Acronym Phase I study of Wilms' tumor gene WT1 peptide vaccination combined with gemcitabine for patients with advanced non-small-cell lung cancer
Region
Japan

Condition
Condition advanced or recurrent non-small-cell lung cancer
Classification by specialty
Pneumology Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 safety of the wt peptide vaccination combined with gemcitabine in advanced lung cancer patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes safety
Key secondary outcomes Response rate
Progression free survival
Overall survival
Immune induction

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 Gemcitabine 1,000 mg/m2/day day1,8,15
WT1 peptide days1,15
q4w , 2 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)histological diagnosis of lung cancer
2)informed of lung cancer
3)failure of standard treatments
4)WT1 expressing cancer
5)HLA type HLA-A-2402
6)PS 0-1
7)age over 20 under 80
8)four weeks or more must pass from the prior treatment
9)Patients expected of 3 months or more survival
10)brain metastases controlled if present
11)lesion that can be evaluated by RECIST
12) Adequate organ function
AST and ALT <=4 times the standard values
Total bilirubin <2.0mg/dL
Creatinine <2.0mg/dL
ECG normal
SpO2>92%
13)Written consent



Key exclusion criteria 1)other active disease
2)pregnancy
3)previous administration of GEM
4)active bleeding or hematological disorders
5)HBV,HCV,HIV carriers
6)active infection
7)progressive brain, meningeal or bone metastasis
8)autoimmnune disorders
9)drug allergies
10)During treatment with immunosuppressive agents
11)interstitial pneumonia
12)Severe psychiatric disease
13)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 Yotaro Izumi
Organization School of Medicine, Keio University
Division name Division of General Thoracic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211ext62333
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yotaro Izumi
Organization School of Medicine, Keio University
Division name Division of General Thoracic Surgery
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL 03-3353-1211ext62333
Homepage URL
Email

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization none
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
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 慶應義塾大学医学部(東京都)

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 10 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 Preinitiation
Date of protocol fixation
2011 Year 03 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 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
2011 Year 03 Month 09 Day
Last modified on
2011 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006211

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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