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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010834
Receipt No. R000012687
Scientific Title Phase Ib study of Valproic Acid (VPA) and 13-cis-RA(isotretinoin) combination therapy for advanced and recurrent neuroblastoma.
Date of disclosure of the study information 2013/05/29
Last modified on 2020/02/04

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Basic information
Public title Phase Ib study of Valproic Acid (VPA) and 13-cis-RA(isotretinoin) combination therapy for advanced and recurrent neuroblastoma.
Acronym Phase Ib of VPA + 13-cis-RA for advanced and reccurent neuroblastoma.
Scientific Title Phase Ib study of Valproic Acid (VPA) and 13-cis-RA(isotretinoin) combination therapy for advanced and recurrent neuroblastoma.
Scientific Title:Acronym Phase Ib of VPA + 13-cis-RA for advanced and reccurent neuroblastoma.
Region
Japan

Condition
Condition advanced and recurrent neuroblastoma
Classification by specialty
Pediatrics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate pharmacokinetics, pharmacodynamics study and feasibility of the
Valproic acid (VPA) as histon deacerylase(HDAC) inhibitor combined with differentiation-inducing therapy by 13-cis RA(isotretinoin).
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes MTD(maximum tolerated dose)
Key secondary outcomes DLT(Identification and generating rate)
Adverse events profile
VPA(target serum concentration )
Response rate
Progression free survival
Overall survival
Proportion of the patients who complete all six courses for all registered.
Pharmacokinetics

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 Fourteen-days oral administration of 13-cis RA every 28 days repeated up to 6 cycles, and concurrent with daily administration of VPA orally to maintained the target concentration.
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
1 years-old <=
Age-upper limit
30 years-old >=
Gender Male and Female
Key inclusion criteria 1.neuroblastoma(historical)
2.The following status of patients completing standard treatment
a. Recurrence, after 2nd-line chemotherapy.
b. Stage2 or 3 with residual disease
c. Stage4
3. Prior history of autologous hematopoietic stem cell transplantation.
4. No prior history of allogeneic hematopoietic stem cell transplantation.
5. More than 7 days after chemotherapy which has hematological DLT.
6. More than 7 days after chemotherapy which has non-hematological DLT
7. More than 21 days after radiation therapy
8.More than 14 days after surgery
9.More than 14 days after 13-cis-RA
10. More than 7 days after erythrocyte or platelet transfusion
11.PS>=50%
12.Any organ function is maintained.
13.No oxygen demand is needed
14.no difficulty to take 15mm
capsule.
15.legal adult:written informed
consent.
16.16 years and over,but, no legal
adult: written informed consent
from both patient and legal
guardian.
17.15 years and under: written
informed consent from 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. abnormality in electrocardiogram
tested within 28 days,requiring
intervention.
4. respiratory or heart disorder
requiring oxygen supply,except
from malignant pleural effusion.
5. women during pregnancy or
breast-feeding.
6. Psychosis.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Kawamoto
Organization National Cancer Research Center
Hospital
Division name Division of Pediatric Oncology
Zip code 104-0045
Address 5-1-1 Tsukiji,Chuo-ku,Tokyo
TEL 03-3542-2511
Email ped-dev@ml.res.ncc.go.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Yasui
Organization National Cancer Research Center
Division name Division of Pediatric Oncology
Zip code 104-0045
Address 5-1-1 Tsukiji,Chuo-ku,Tokyo, Japan.
TEL 03-3542-2511
Homepage URL
Email nyasui@ncc.go.jp

Sponsor
Institute National Cancer Research Center
Hospital
Division of Pediatric Oncology
Institute
Department

Funding Source
Organization National Cancer Research Center
Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor National cacncer center
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Cancer Center
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo
Tel 03-3542-2511
Email ped-dev@ml.res.ncc.go.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 国立がん研究センター中央病院

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 29 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 Completed
Date of protocol fixation
2013 Year 04 Month 05 Day
Date of IRB
2013 Year 04 Month 30 Day
Anticipated trial start date
2013 Year 05 Month 29 Day
Last follow-up date
2016 Year 03 Month 03 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 05 Month 29 Day
Last modified on
2020 Year 02 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012687

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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