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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000002001
Receipt No. R000002437
Scientific Title Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Date of disclosure of the study information 2009/05/24
Last modified on 2017/11/29

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Basic information
Public title Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Acronym Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Scientific Title Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Scientific Title:Acronym Phase I/II clinical trial of WT1 peptide-based vaccine for the patients with malignant tumors.
Region
Japan

Condition
Condition Malignant solid tumors,
Malignant lymphoma,
Multiple Myeloma, Acute leukemia
Classification by specialty
Medicine in general Hematology and clinical oncology Surgery in general
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Safety
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes 1. Safety
Evaluation by NCI-CTCAE ver 3.0
2. Efficacy
Clinical response rate
Disease control rate
Key secondary outcomes 1. QOL outcomes
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 3 mg of the HLA-A*2402-restricted, 9-mer modified WT1 peptide (p235-243:CYTWNQMNL) emulsified with Montanide ISA51 adjuvant. The WT1 vaccination was scheduled to be performed 12 times at weekly intervals. The safety and efficacy are evaluated by the NCI-CTC and RECIST criteria from 1 to 3 weeks after 12th WT1 vaccination .
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
16 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria 1. Diagnosed as malignant solid tumors, malignant lymphoma, mutiple myeloma or acute leukemia.
2. Informed about his diagnosis
3. Not expected to make any further efficacy by standard treatment
4. WT1 expression in malignant cells
5. HLA-A*2402 positive
6. Having evaluable diaseas
7. No chemotherapy/radiation has been performed within 4 weeks and no hormone/BRM therapy has been performed within 3 weeks before the start of vaccination.
8. There is not uncontrolable brain metastasis.
9. Performance status (ECOG) 0-1
10. Meet the following criteria for organ functions
1)Neutrophil more than 1,000/microliter, Platelet more than 75,000/microliter, Hemoglobin more than 8g/dl
2) Serum creatinine less than 2.0 mg/dL
3) Serum bilirubin less than 1.5 folds of the upper normal limit
4) Serum AST/GOT less than 3 folds of the upper normal limit
5) Serum Albumin more than 2.5g/dl
6) Arterial oxygen saturation more than 94% in room air
11. Pleural effusion, ascites and pericardial effusion are not detected or
controlled.
12 Survival period is expected more than 3 months
13. Informed consent has been obtained
Key exclusion criteria 1. There is deep-seated active infection.
2,3 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.
4. Dependent on total parenteral nutrition(TPN)
5. There is expanded liver metastasis.
6. There are other malignancies.
7. There are hematopoietic stem cell disorders such as myelodisplastic syndorome(MDS) and myeloproliferative disorders (MPD).
8. Post allogeneic hematopoietic stem cell transplantation
9. Pregnant or lactating woman
10. There is severe psychiatric disorder.
11. Responsible doctors judged the patient inappropriate for the trial
Target sample size 30

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 Clinical Laboratory Science
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 Yoshihiro Oka
Organization Osaka University Graduate School of Medicine
Division name Department of Cancer Immunotherapy
Zip code
Address 2-2, Yamada-oka, Suita City, Osaka, Japan
TEL 06-6879-3676
Homepage URL http://sahswww.med.osaka-u.ac.jp/~hmtonc/vaccine/index.htm
Email yoshi@cit.med.osaka-u.ac.jp

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

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 24 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 No longer recruiting
Date of protocol fixation
2003 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2003 Year 11 Month 01 Day
Last follow-up date
2015 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
2009 Year 05 Month 24 Day
Last modified on
2017 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002437

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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