UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013325 |
|---|---|
| Receipt number | R000015552 |
| Scientific Title | WT1 peptide-based cancer vaccine in patients with high risk rhabdomyosarcoma, a multicenter, phase 2 clinical study |
| Date of disclosure of the study information | 2014/03/04 |
| Last modified on | 2014/03/04 12:03:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
WT1 peptide-based cancer vaccine in patients with high risk rhabdomyosarcoma, a multicenter, phase 2 clinical study
Acronym
WT1 peptide-based cancer vaccine in patients with high risk rhabdomyosarcoma, a multicenter, phase 2 clinical study
Scientific Title
WT1 peptide-based cancer vaccine in patients with high risk rhabdomyosarcoma, a multicenter, phase 2 clinical study
Scientific Title:Acronym
WT1 peptide-based cancer vaccine in patients with high risk rhabdomyosarcoma, a multicenter, phase 2 clinical study
Region
| Japan |
Condition
Condition
rhabdomyosarcoma
Classification by specialty
| Hematology and clinical oncology | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Investigate the efficacy and safety of the WT1 peptide-based cancer vaccine in the patients with high risk rhabdomyosarcoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
2 year relapse rate
Key secondary outcomes
2 year progression free rate
safety
over all survival
immunological monitering
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
WT1 peptide-based cancer vaccine weekly intradermal injection WT1 peptide
mp235: HLA-A*2402 restricted WT1peptide
or
np126: HLA-A*0201 restricted WT1peptide Adjuvant
Montanide ISA51
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
| Not applicable |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Diagnosed as rhabdomyosarcoma
2. Metastatic alveolar or embryonal histology or unresectable rabdomyosarcoma group III
3. Performance Status 0-2
4. Under 30 years old
5. HLA-A*2402, A*0201
6. Obtained complete remission or negative on PET-CT
7. WT1 positive
8. Adequate organ function
9. Written informed consent
Key exclusion criteria
1. Active bacterial or fungal infection
2. Severe complications
3. MDS, MDS/MPD, MPD
4. Inadequate physical condition, as diagnosed by the primary physician
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiko Hashii |
Organization
Osaka university graduate school of medicine
Division name
Pediatrics
Zip code
Address
2-2, Yamada-oka, Suita-city, Osaka, Japan
TEL
06-6879-3932
areken@ped.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiko Hashii |
Organization
Osaka university graduate school of medicine
Division name
Pediatrics
Zip code
Address
2-2, Yamada-oka, Suita-city, Osaka, Japan
TEL
06-6879-3932
Homepage URL
areken@ped.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university graduate school of medicine Pediatrics
Institute
Department
Personal name
Funding Source
Organization
The Japanese Ministries of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 03 | Month | 04 | 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
| 2014 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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
| 2014 | Year | 03 | Month | 04 | Day |
Last modified on
| 2014 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015552
