UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010257 |
|---|---|
| Receipt number | R000008652 |
| Scientific Title | Immunotherapy using WT1 peptide and a pertussis whole cell vaccine against malignant bone and soft tissue tumors: A phase I/II study |
| Date of disclosure of the study information | 2013/03/18 |
| Last modified on | 2021/03/22 12:03:21 |
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Basic information
Public title
Immunotherapy using WT1 peptide and a
pertussis whole cell vaccine against malignant bone and soft tissue tumors: A phase I/II study
Acronym
Immunotherapy against malignant bone and soft tissue tumors
Scientific Title
Immunotherapy using WT1 peptide and a
pertussis whole cell vaccine against malignant bone and soft tissue tumors: A phase I/II study
Scientific Title:Acronym
Immunotherapy against malignant bone and soft tissue tumors
Region
| Japan |
Condition
Condition
Malignant bone and soft tissue tumors
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is undertaken to evaluate the
safety and anti-tumor effects of an
immunotherapy using WT1 peptide and
pertussis whole cell vaccine against malignant bone and soft tissue tumors. Patients to be recruited must
bear at least one copy of either HLA-A*
02:01, A*02:06, A*02:07 or A*24:02 gene.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Evaluation of side effects(Phase I)
Progression-free survival(Phase II)
Key secondary outcomes
Disease control rate, survival rate, local control rate, overall survival, adverse events, immunological responses
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
3.0mg of WT1 peptide and 0.1ml of
pertussis whole cell vaccine will be
administrated intradermally. The
administration interval is essentially every week. 24 weekly immunizations are planned.
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
| 13 | years-old | <= |
Age-upper limit
| 88 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been histologically
diagnosed as either malignant bone tumor or malignant soft tissue tumor.
2) Patients must bear at lease one copy of either HLA-A*24:02, A*02:01, A*02:06, or A*02:07 gene.
3) The tumor tissue is positibe by stained for WT1 by immunohistochemistry.
4) Age 13 to 88
5) The patients' Karnofsky Index
should be 60% or more(performance status
(ECOG should be 0-2).
6) Expected survival time should be three
months or greater.
7) Sufficient function of important organs including heart, lung, liver, kidney and bome marrow. And patients must satisfy the followings:
Creatinin <= 3.0mg/dl
BUN <= 25 mg/dl
Total Bilirubin <= 1.5 mg/dl
AST <= 105 U/l
ALT <= 120 U/l
Neutrophil >= 1,500/mm3
Platelet >= 75,000/mm3
Hemoglobin >= 8.0g/dl
ECG: no serious irregularities
PaO2 >= 70mmHg (room air)
8) Patients without additional malignant
diseases
9) Written informed consents are obtained
from patients after giving sufficient
explanations and obtaining their
understandings about disease conditions.
Key exclusion criteria
1) Patients with uncontrollable infectious diseases (including active Tuberculosis).
2) Patients with severe complications(malignant hypertension, severe congestive heart failure, severe colonary insufficiency, myocardial, infarction within three months, terminal stage of liver cirrhosis, uncontrollable diabetes mellitus, severe pulmonary fibrosis, active interstitial pneumonitis, etc.).
3) Patients after allogeneic bone marrow transplantation.
4) Pregnant or breast-feeding women.
5) Patients with severe psychiatric diseases.
6) Patients who have participate in any other clinical trial.
7) Patients who have previously participated in this clinical trial.
8) Any patients disqualified by a study physician because of medical, psychological, or any other reason.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | |
| Last name | Namba |
Organization
Kochi Medical School
Division name
Department of Orthopaedic Surgery
Zip code
783-8505
Address
Kohasu, Okoh-cho, Nankoku, Kochi 783-8505, Japan
TEL
088-880-2386
im35@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Udaka |
Organization
Kochi Medical School
Division name
Anti-tumor Immunotherapy Research Network, Central Office, Department of Immunology
Zip code
783-8505
Address
Kohasu, Okoh-cho, Nankoku, Kochi 783-8505, Japan
TEL
088-880-2318
Homepage URL
vaccine@kochi-u.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Kochi
Medical School
Institute
Department
Personal name
Funding Source
Organization
NEC Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kochi Medical School
Address
Kohasu, Oko-cho, Nankoku, Kochi, Japan
Tel
088-880-2719
im62@kochi-u.ac.jp
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
| 2013 | Year | 03 | Month | 18 | 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
20
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
| 2011 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | 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 | 03 | Month | 16 | Day |
Last modified on
| 2021 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008652
