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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010929
Receipt No. R000012777
Scientific Title Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Date of disclosure of the study information 2013/06/11
Last modified on 2019/06/17

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Basic information
Public title Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Acronym Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Scientific Title Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Scientific Title:Acronym Safety test of long-term administration of WT1 peptide-based immunotherapy for patients with malignant tumors
Region
Japan

Condition
Condition Malignant tumor
Classification by specialty
Medicine in general Hematology and clinical oncology Pediatrics
Neurosurgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Evaluation of safety and antitumor effects on long-term administration of WT1 peptide vaccination
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety
Evaluation by NCI-CTCAE ver 4.0

Key secondary outcomes 1. Efficacy
2. Immune responses to WT1

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
Medicine Vaccine
Interventions/Control_1 The patient is intradermally injected with the WT1 peptide emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be performed every two or four weeks.
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
1 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria 1. Diagnosed as malignant solid tumors or acute leukemia and previously treated by WT1 vaccine.
2. Not expected to make any further efficacy by standard treatment
3. HLA-A*2402 positive
(In the vaccine-protocol using helper peptide, HLA class DRB1*04:05,15:01,15:02,08:03,HLA-DPB1*09:01 or 05:01 positive)
4. Judged as having clinical effects due to previous WT1 vaccine
5. Meet the following criteria for organ functions
1)Neutrophil more than 1,000/microliter, Platelet more than 50,000/microliter, Hemoglobin more than 7g/dl
2) Serum creatinine less than 2.0 mg/dL
3) Serum bilirubin less than 2.0 mg/dL
4) Serum AST/GOT less than 4 folds of the upper normal limit
5) Arterial oxygen saturation more than 94% in room air
6. Age 0-85
7. Performance status (ECOG) 0-1
8. Informed consent has been obtained
Key exclusion criteria 1. There is deep-seated active infection.
2. There are severe complications including malignant hypertention, cardiac failure, liver cirrhosis, severe DM, severe lung fiblosis, active interstitial pneumonitis.Patients who have complications that are considered inappropriate for the trial.
3. There is severe psychiatric disorder.
4. Responsible doctors judged the patient inappropriate for the trial
Target sample size 29

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Haruo Sugiyama
Organization Osaka University Graduate School of Medicine
Division name Department of Cancer Immunology
Zip code
Address 1-7, Yamada-oka, Suita City, Osaka , Japan
TEL 06-6879-2593
Email sugiyama@sahs.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Oji
Organization Osaka University Graduate School of Medicine
Division name Department of Clinical Laboratory Science
Zip code
Address 1-7, Yamada-oka, Suita City, Osaka , Japan
TEL 06-6879-2597
Homepage URL
Email oji@sahs.med.osaka-u.ac.jp

Sponsor
Institute Department of Cancer immunotherapy, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Donation for department of cancer immunotherapy in Osaka Graduate School of Medicine
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 大阪大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 11 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 Terminated
Date of protocol fixation
2013 Year 06 Month 03 Day
Date of IRB
2013 Year 06 Month 03 Day
Anticipated trial start date
2013 Year 06 Month 03 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 11 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012777

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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