UMIN-CTR Clinical Trial

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
Email	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
Email	vaccine@kochi-u.ac.jp

Sponsor
Institute	Department of Orthopaedic Surgery, Kochi Medical School
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008652