UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005226 |
|---|---|
| Receipt number | 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 12:49:47 |
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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
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
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006211
