UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012032 |
|---|---|
| Receipt number | R000014062 |
| Scientific Title | Phase Ib study of 131I-metaiodobenzylguanidine(MIBG) therapy with Valproic Acid(VPA) for high risk or recurrent neuroblastoma |
| Date of disclosure of the study information | 2013/10/14 |
| Last modified on | 2020/02/04 14:34:00 |
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Basic information
Public title
Phase Ib study of 131I-metaiodobenzylguanidine(MIBG) therapy with Valproic Acid(VPA) for high risk or recurrent neuroblastoma
Acronym
Phase Ib study of VPA and 131I-MIBG for recurrent / resistant neuroblastoma
Scientific Title
Phase Ib study of 131I-metaiodobenzylguanidine(MIBG) therapy with Valproic Acid(VPA) for high risk or recurrent neuroblastoma
Scientific Title:Acronym
Phase Ib study of VPA and 131I-MIBG for recurrent / resistant neuroblastoma
Region
| Japan |
Condition
Condition
Intractable neuroblastoma
Classification by specialty
| Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether 131I-MIBG with concurrent VPA, a histon deacerylase (HDAC) inhibitory drug, administration can be completed safely without hematopoetic stem cell rescue
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Proportion of patients who can recover at normal hematologic status without hematopoetic stem cell rescue
Key secondary outcomes
DLT(profile and incidence)
Adverse events profile
Proportion of patients maintaining target serum concentration of VPA
Clinical benefit rate
Response rate
identification of problem and solution for perform 131I-MIBG therapy
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
(1) After enrollment, starting valproic acid (VPA) and adjusting VPA dosing to reach and keep the target concentration (100ug/ml).
(2) Preparing for 131I-MIBG administration by assessing disease status (123I-MIBG, Bone marrow biopsy etc.) and training for staying alone in isolated room
(3) After second admission, 131I-MIBG 12 mCi/kg is infused intravenously, concurrently using KI and perchlorate potassium for protecting thyroid.
(4) outpatient ward management after confirming fall of radiation dose from body.
(5) G-CSF s.c. or reserved stem cell transplantation infusion according patient's hematologic status.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. histological proven neuroblastoma
2. ability to control urination and body weight = < 18kg
3. PS (Lansky) >= 50%
4. any radiologically confirmed residual disease which are not shrinking or any tumor associated symptoms, despite prior chemotherapies
5. any diseases evaluable by 123I-MIBG scan performed within 8 weeks
6. any non-irradiated disease with 123I-MIBG uptake which compress spinal cord
7. autologous hematopoietic stem cell product available for re-infusion after MIBG treatment whose quantity is more than 1.5*10^6 CD34+ cells/kg or 1.0*10^6 CD34+ cells/kg if the quality is confirmed within 8 weeks.
8. 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
9.7 days or more have passed since the
anti-cancer drug (dosage restriction
toxicity is non-hematologic toxicity)
10. 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.
11. No oral 13-cis-RA within 14 days.
12 Any red blood cell (RCC) transfusion or platlet cell (PC) transfusion history within 7 days from registration or the last RCC or PC transfusion.
13. Normal organ function confirmed by laboratory tests within 14 days
14. No exertional dyspnea and no oxygen supply for everyday life.
15. No need for any anti-epileptics, phycotropics or anti-hypertentsivesexcept VPA during treatment.
16. 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. abnormality in electrocardiogram
tested within 28 days,requiring
intervention
4. Psychosis which is not appropriate for participating in this study
Target sample size
10
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
ped-dev@ml.res.ncc.go.jp
Public contact
Name of contact person
| 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
Homepage URL
ped-dev@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Research Center Hospital
Institute
Department
Personal name
Funding Source
Organization
National Cancer Research Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
NCC_IRBoffice@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（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 14 | 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 | 01 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2013 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 14 | 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 | 10 | Month | 14 | Day |
Last modified on
| 2020 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014062
