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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031312
Receipt No. R000035722
Scientific Title Phase 1/2 clinical trial of immunotherapy with fusions of tumor cells and dendritic cells for pediatric refractory brain tumor
Date of disclosure of the study information 2018/02/15
Last modified on 2018/02/15

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Basic information
Public title Phase 1/2 clinical trial of immunotherapy with fusions of tumor cells and dendritic cells for pediatric refractory brain tumor
Acronym Dendritic cell-based immunotherapy for pediatric refractory brain tumor
Scientific Title Phase 1/2 clinical trial of immunotherapy with fusions of tumor cells and dendritic cells for pediatric refractory brain tumor
Scientific Title:Acronym Dendritic cell-based immunotherapy for pediatric refractory brain tumor
Region
Japan

Condition
Condition Pediatric refractory brain tumor
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of immunotherapy with fusion cells of tumor cells and dendritic cells for refractory brain tumor in childhood and AYA.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Safety
Key secondary outcomes 2-year overall survival (OS) rate, 1-year progression free survival (PFS) rate, iRANO criteria

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
Vaccine
Interventions/Control_1 In Phase 1, we evaluate the safety (DLT) by three steps according to 3+3 design method. In Phase 2, we evaluate the safety and efficacy with 0.5-10 x10^6 cells in dendritic cell count. Fusion cell inoculation will be repeated 3-10 times in each 28-84 days cycle.
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
3 years-old <=
Age-upper limit
25 years-old >
Gender Male and Female
Key inclusion criteria <Tentative inclusion criteria>
Patients will be tentatively enrolled in this clinical trial, when they satisfy the following tentative inclusion criteria.

1) A patient who is suspected a relapse or refractory pediatric brain tumor with poor prognosis.
2) A patient who needs to receive a surgical tumor resection.
3) A patient who is tolerable to receive gathering peripheral blood mononuclear cells by an apheresis method.
4) Age at enrollment is 3 to <25 year-old
5) A patient who has grade 0 to 3 of the Performance Status. Patients with a PS score of 4 due to neurological symptoms associated with the primary disease may be eligible if patients could go to outpatient clinic without any respiratory supports.
6) A patient who is suspected to be alive for more than 3 months.
7) A patient who does not have multiple primary cancer.
8) A patient for whom either the legally acceptable representative or the patient (if aged > 16 years) have provided written voluntary consent to participation in this study after fully receiving and understanding the information about this study.
9) A patient who satisfies following criteria without functional failure of major organs, such as heart, lung, liver, kidney, and bone marrow etc.
WBC > 1,500/microL
Platelet > 50,000/microL
Hb > 9.0/dL
Serum creatinine < 3-fold the upper limit of the normal range based on each age (ULN)
Total bilirubin < 3-fold the ULN
AST, ALT < 120U/L

<Final inclusion criteria>
Tentatively enrolled patients will be truly enrolled as a subject of this clinical trial, when they satisfy the following final inclusion criteria.

1) A patient who is histologically proven recurrent or refractory brain tumor.
2) A patient who has autologous cultured tumor cells available to fuse with dendritic cells.
Key exclusion criteria 1) A patient who has sever immune deficiency.
2) A patient who has a past or current history of autoimmune disease.
3) A patient who is administrated immunosuppressive agents for a long period, and is difficult to stop it.
4) A patient who received chemotherapy (including with molecular target therapy) or radiotherapy within 21 days.
5) A patients who underwent allogeneic hematopoietic stem cell transplant.
6) A patient who had recovered from some viral infection (influenza virus or gastroenteritis) within 14 days.
7) A patient who has an allergy to biological medicines.
8) A patient who previously received WT1 peptide vaccine or other immunotherapy.
9) A patient who has positive of HBs antigen, HIV antibody, HCV antibody, or HTLV antibody.
10) A patient who has severe infectious disease over Grade 3 of CTCAE v4.0.
11) A patient who has sever lung disease (Class 3 or more in the Hugh-Jones classification).
12) A patient who has severe heart disease (Class 3 or more in the NYHA).
13) A patient who has some uncontrollable complication.
14) A pregnant or lactating patient.
15) A patient who is involved in other clinical trials.
16) A patients who are inappropriate for participation in the study for other reasons in the opinion of the investigator or sub-investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takaaki Yanagisawa
Organization Jikei University School of Medicine
Division name Neurosurgery
Zip code
Address 3-25-8 Nishishinbashi Minato-ku, Tokyo
TEL 81-3-3433-1111
Email takaakipno@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayoshi Yamaoka
Organization Jikei University School of Medicine
Division name Pediatrics
Zip code
Address 3-25-8 Nishishinbashi Minato-ku, Tokyo
TEL 81-3-3433-1111
Homepage URL
Email yamaoka@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization Jikei University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 東京慈恵会医科大学附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 02 Month 15 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
2018 Year 02 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 15 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
2018 Year 02 Month 15 Day
Last modified on
2018 Year 02 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035722

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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