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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012001
Receipt No. R000013996
Scientific Title Feasibility and pharmacokinetic study of ch14.18 immunotherapy using teceleukin and CSF (mirimostim, filgrastim) for neuroblastoma
Date of disclosure of the study information 2013/10/09
Last modified on 2016/04/11

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Basic information
Public title Feasibility and pharmacokinetic study of ch14.18 immunotherapy using teceleukin and CSF (mirimostim, filgrastim) for neuroblastoma
Acronym Feasibility and pharmacokinetic study of ch14.18 immunotherapy for neuroblastoma
Scientific Title Feasibility and pharmacokinetic study of ch14.18 immunotherapy using teceleukin and CSF (mirimostim, filgrastim) for neuroblastoma
Scientific Title:Acronym Feasibility and pharmacokinetic study of ch14.18 immunotherapy for neuroblastoma
Region
Japan

Condition
Condition intractable neuroblastoma
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate feasibility of ch14.18 with teceleukin and M-CSF (M regimen) or GCSF (G regimen)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes DLT of ch14.18, teceleukin, mirimositim, filgramostim (phaseI)
Proportion of completing 5 courses of M regimen and G regimen (phaseIIa)
Key secondary outcomes 1. adverse events profile
2. clinical benefit rate. response rate. progression free survival. disease free survival. overall survival.
3. pharmacokinetics and dose-response for ch14.18 and teceleukin
4. antibody dependent cell-mediated cytotoxicity activity
5. anti-chimera antibody response proportion

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment M
CSF regimen (ch14.18 10-20h div d4-7, mirimostim 2h div d1-14) and IL2 regimen (ch14.18 10-20h div d8-11, teceleukin 24h div d1-4, d8-11) are performed alternately, starting CSF regimen upto 5 courses
Interventions/Control_2 Treatment G
CSF regimen (ch14.18 10-20h div d4-7, filgrastim s.c. d1-14) and IL2 regimen (ch14.18 10-20h div d8-11, teceleukin 24h div d1-4, d8-11) are performed alternately, starting CSF regimen upto 5 courses.
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
2 years-old <=
Age-upper limit
45 years-old >=
Gender Male and Female
Key inclusion criteria 1. Histogically proven neuroblastoma
2. Prior history of high-dose chemotherapy (HDC).
3. (phaseI): B. is required.
(phaseIIa): A. or B. is required.
A. No prior chemotherapy after HDC, 180 days or less after stem-cell transplantation and none of the followings: radiologically confirmed progressive disease, moderate bone marrow invasion, or, high urine HVA or VMA concentration
B. One or more prior chemotherapy after HDC and at least one of the followings: one and more radiologically confirmed progressive site(s), bone marrow invasion, high urine HVA or VMA concentration, and tumor associated symptom(s)
4. PS(Lansky or Karnofsky) >= 50%
5. If the last chemotherapy contains one or more drugs with hematologic dose limiting toxicity (DLT),
7 days or more have passed since last use of anti-tumor agents which are administerd protractedly and 14 days or more have passed since last use of anti-tumor agents which are not administered in protracted way.
6. 7 days or more have passed since last chemotherapy which does not contain any drugs with hematologic DLTs
7. No prior irradiation within 14 days if radiation fields is limited.
No prior irradiation within 3 months if radiation fields contain either whole brain and spine, whole abdomen, whole lung, whole body, or more than 50% of pelvis.
No prior irradiation within 6 weeks if radiation fields contain either less than 50% of pelvis, or 5 or less vertebras.
8. No prior allogeneic hematopoietic stem cell transplantation
9. Normal organ function confirmed by laboratory tests within 14 days
10. No intracranial hemorrhagic episode within one week and platelet count >= 50000/ul and Hb >= 8.0g/dl more than three days after last blood transfution.
11. Written informed consent from patient and/or legal guardian
Key exclusion criteria 1. Active double cancer(synchronous
double cancer and metachronous
double cancer within 5 disease
-free years),excluding carcinoma
In situ(lesions equal to
Intraepithelial or intramucosal
Cancer)judged to have been cured
with local treatment.
2. Active infection requiring
systemic medication.
3. 14 days or less after last administration of systemic steroids
4. 28 days or less after last administration of immunogloblin
5. Any abnormalities in electrocardiogram
tested within 28 days,which require
intervention.
6. Fractional Shortning < 30% or Ejection Fraction < 55% by echocargiogram within 28 days.
7. Respiratory or heart disorder requiring oxygen supply
8. Possibilly/confirmed pregnant or lactating
9. Impossible for sexually active patients to use one of effective methods of birth control during and 6 month after treatment
10. Psychosis which is not appropriate for participating in this study.
11. allergy or predisposition for
any elements involved in all the investigational agents in this study
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Junichi Hara
Organization Osaka City General Hospital
Division name Pediatric Hematology and Oncology department
Zip code
Address 2-13-22 Miyakojima-hondori Miyakojima-ku, Osaka 534-0021 JAPAN
TEL 06-6929-1221
Email j-hara@hospital.city.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Kawamoto
Organization National Cancer Research Center
Division name Division of Pediatric Oncology
Zip code
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL 03-3542-2511
Homepage URL
Email shoni@ml.res.ncc.go.jp

Sponsor
Institute A study group for "Research on Applying Health Technology" of health and Labor Sciences Research Grants
Institute
Department

Funding Source
Organization Ministry of Health,Labour and
Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor investigational agent suppliers:
OHARA Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Shionogi & Co., Ltd., Japan Chemical Research Pharmaceutical Co., Ltd.
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 大阪市立総合医療センター(大阪府)、国立がん研究センター中央病院(東京都)

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 09 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://meeting.ascopubs.org/cgi/content/abstract/33/15_suppl/e21018?sid=9c9f82cd-3837-4b90-9279-406e
Number of participants that the trial has enrolled
Results Sixteen (8 each in R1 and R2) recurrent pts were enrolled. All two DLT (Grade4 thrombocytopenia, Grade3 hypokalemia) of 12 pts in pI occurred only on IL2 regimen (IL2:level0, ch14.18: level1). The recommended dose (RD) of IL2 was level0 (0.75 million IU/m2 (d1-4) and 1 million IU/m2 (d8-11)). the RDs of All the other agents were determined at level1 (Dmab:17.5mg/m2, M-CSF: 6 million IU/m2, G-CSF: 5 ug/kg). SAE were 3 blood stream infections, 1 Grade 3 pancreatitis (inflammation around metastatic lesion in pancreas), 2 upper respiratory infection and 1 Grade4 transaminitis. 7/8 in R1 and 5/8 in R2 completed more than 5 cycles. All eleven consented pts recieved 7 cycles. The result of PK analysis is presented in the following table. Augmentation of ADCC was confirmed in both R1 and R2. More than half pts were positive for HACA assay.
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
2012 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 10 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
2013 Year 10 Month 09 Day
Last modified on
2016 Year 04 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013996

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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