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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016848
Receipt No. R000019561
Scientific Title A phase II study of ICE-containing induction therapy followed by high-dose chemotherapy with BU+LPAM and delayed local treatment for children with high-risk neuroblastoma
Date of disclosure of the study information 2015/03/19
Last modified on 2015/03/19

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Basic information
Public title A phase II study of ICE-containing induction therapy followed by high-dose chemotherapy with BU+LPAM and delayed local treatment for children with high-risk neuroblastoma
Acronym JNBSG NBHR15
Scientific Title A phase II study of ICE-containing induction therapy followed by high-dose chemotherapy with BU+LPAM and delayed local treatment for children with high-risk neuroblastoma
Scientific Title:Acronym JNBSG NBHR15
Region
Japan

Condition
Condition Neuroblastoma
Classification by specialty
Hematology and clinical oncology Surgery in general Pediatrics
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate an efficacy and safety of multimodal therapy consisted of a novel induction chemotherapy combining conventional 05A1/05A3 (cyclophosphamide, vincristine, pirarubicin, and cisplatin) and ICE (ifosfamide, etoposide, and carboplatin), myeloablative high-dose chemotherapy consisted of busulfan and melphalan followed by autologous hematopoietic stem cell rescue, delayed local therapy, and radiation therapy for children 18 years old or younger with INRG classification high-risk neuroblastoma with unresectable primary tumor.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Complete remission rate at the end of the protocol therapy
Key secondary outcomes 1) Rate of adverse events during the protocol therapy
2) Completion rate of the protocol therapy
3) Clinical response rate before autologous hematopoietic stem cell transplantation
4) Clinical response rate after autologous hematopoietic stem cell transplantation (but before surgical resection)
5) Clinical response rate after completion of the protocol therapy (including surgical resection and radiotherapy)
6) Completion rate of induction chemotherapy
7) Number of harvested autologous hematopoietic stem cells
8) Evaluation of MIBG scintigraphy before high-dose therapy and after radiotherapy

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 Induction chemotherapy
1) 05A1: cyclophosphamide (CPA), vincristine (VCR), pirarubicin (THP), cisplatin (CDDP)
2) 05A3: CPA, VCR, THP, CDDP
3) 05A3: CPA, VCR, THP, CDDP
4) ICE: ifosphamide (IFO), carboplatin (CBDCA), etoposide (VP16)
5) ICE: IFO, CBDCA, VP16

Myeloablative high-dose chemotherapy (busulfan and melphalan) followed by autologous stem cell rescue

Surgical resection

Local radiotherapy
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
18 years-old >=
Gender Male and Female
Key inclusion criteria (1) Age 180 days to 18 years old at study entry.
(2) Histologically confirmed neuroblastoma or ganglioneuroblastoma by open biopsy of primary tumor or metastatic tumor, or by bone marrow biopsy. Patients can be registered before pathological diagnosis of primary tumor if high level of VMA/HVA and tumor cells in bone marrow were confirmed.
(3) INRG classification high-risk cases with unresectable primary tumor at diagnosis.
(4) No history of previous chemotherapy and/or radiotherapy, unless risk classification was changed
(5) Patients must have sufficient organ function satisfying the laboratory data listed below
1. Lansky performance status score of 30 or higher
2. WBC 2000/mm3 or higher
3. ALT 300IU/L or lower; T.Bil 2.0mg/dL or lower
4. Serum creatinine level
0.8mg/dL or lower for patients younger than 5 years old
1.2mg/dL or lower for patients 5 to <10 years old
1.5mg/dL or lower for patients 10 to <18 years old
5. No heart disease which require any treatment
(6) No active infection
(7) All patients and/or their parents or legal guardians must sigh a written informed consent
Key exclusion criteria (1) Patients with active coexistent malignant neoplasms
(2) Patients who are pregnant or breastfeeding mother
(3) Patients with mental disorder who is considered inappropriate for study participation
(4) Patients with any other inappropriate condition judged by physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kimikazu Matsumoto
Organization National Center for Child Health and Development
Division name Children's Cancer Center
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo
TEL 03-3416-0181
Email matsumoto-kmk@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kimikazu Matsumoto
Organization National Center for Child Health and Development
Division name Children's Cancer Center
Zip code
Address 2-10-1 Okura, Setagaya-ku, Tokyo
TEL 03-3416-0181
Homepage URL
Email matsumoto-kmk@ncchd.go.jp

Sponsor
Institute Japan Neuroblastoma Study Group (JNBSG)
Institute
Department

Funding Source
Organization Grant for innovative clinical cancer research from the Ministry of Health, Labour, and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 19 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
2014 Year 12 Month 05 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 29 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
2015 Year 03 Month 19 Day
Last modified on
2015 Year 03 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019561

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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