UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008397 |
|---|---|
| Receipt number | R000009878 |
| Scientific Title | Clinical trial of WT1 peptide therapy after WT1 and/or tumor lysates-pulsed dendritic cell vaccination therapy for patients with malignant glioma |
| Date of disclosure of the study information | 2012/08/01 |
| Last modified on | 2012/07/10 19:38:35 |
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Basic information
Public title
Clinical trial of WT1 peptide therapy after WT1 and/or tumor lysates-pulsed dendritic cell vaccination therapy for patients with malignant glioma
Acronym
Clinical trial of WT1 peptide therapy after WT1 and/or tumor lysates-pulsed dendritic cell vaccination therapy for patients with malignant glioma
Scientific Title
Clinical trial of WT1 peptide therapy after WT1 and/or tumor lysates-pulsed dendritic cell vaccination therapy for patients with malignant glioma
Scientific Title:Acronym
Clinical trial of WT1 peptide therapy after WT1 and/or tumor lysates-pulsed dendritic cell vaccination therapy for patients with malignant glioma
Region
| Japan |
Condition
Condition
Malignant glioma
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The object of this study is to investigate the safety and the efficacy of WT1 peptide therapy after the standard therapy followed by WT1 and/or tumor lysates-pulsed dendritic cell vaccination therapy for patients with malignant glioma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
The safety and the efficacy of clinical findings and tumor size on MR images are analyzed 12 weeks after the initial WT1 peptide vaccination.
Key secondary outcomes
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 |
Interventions/Control_1
One mg of WT1 peptide is injected into the axillary areas with 1Ke of OK-432 at intervals of 2 weeks for 12 consecutive 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Histologially Grade 3 or Grade 4 glioma was confirmed
2) The patient had already received standard therapy including conventional radiotherapy and chemotherapy, and WT1 and/or tumor lysates-pulsed dendrite cell vaccination.
3) Age: more than 20 years
4) Karnofsky Performance Status (KPS): more than 60%
5) Estimated survival of more than 3 months
6) No severe organ dysfunction
7) The written informed consent of the patient
Key exclusion criteria
1) The patient had received the WT1 peptide therapy previously.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichi Sakai |
Organization
Shinshu University School of Meidicne
Division name
Department of Neurosurgery
Zip code
Address
Asahi 3-1-1, Matsumoto 390-8621, Nagano, Japan
TEL
0263-37-2690
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigetaka Shimodaira |
Organization
Shinshu University Hospital
Division name
Cell Processing Center
Zip code
Address
sahi 3-1-1, Matsumoto 390-8621, Nagano, Japan
TEL
0263-37-3240
Homepage URL
http://wwwhp.md.shinshu-u.ac.jp/
Sponsor or person
Institute
Group of WT1 peptide therapy in Shinshu Universiry Hospital
Institute
Department
Personal name
Funding Source
Organization
Shinshu University Hospital
Cell Processing Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 06 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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
| 2012 | Year | 07 | Month | 10 | Day |
Last modified on
| 2012 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009878
