UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019840 |
|---|---|
| Receipt number | R000022902 |
| Scientific Title | Treatment of Children with All Stage of Hepatoblastoma with Temsirolimus(IND#122782, NSC#683864) Added to High Risk Stratum Treatment |
| Date of disclosure of the study information | 2015/11/18 |
| Last modified on | 2024/01/25 12:26:24 |
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Basic information
Public title
Treatment of Children with All Stage of Hepatoblastoma with Temsirolimus(IND#122782, NSC#683864) Added to High Risk Stratum Treatment
Acronym
Treatment of Vincristine, Irinotecan, and Temsirolimus for Children with High Risk Hepatoblastoma (AHEP0731)
Scientific Title
Treatment of Children with All Stage of Hepatoblastoma with Temsirolimus(IND#122782, NSC#683864) Added to High Risk Stratum Treatment
Scientific Title:Acronym
Treatment of Vincristine, Irinotecan, and Temsirolimus for Children with High Risk Hepatoblastoma (AHEP0731)
Region
| Japan | North America |
Condition
Condition
Hepatoblastoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery | Pediatrics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To estimate the response rate to vincristine, irinotecan and temsirolimus in previously untreated children with high-risk, metastatic hepatoblastoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
response rate at the end of 2nd cycle
Key secondary outcomes
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 | Maneuver |
Interventions/Control_1
VIT therapy (Irinotecan (50mg/m2 or 1.67mg/kg for <10kg, Day1-5)+ Temsirolimus(35mg/m2 or 1.2mg/kg for <10kg, Day1 and 8) + Vincristine(1.5mg/m2 or 0.05mg/kg for <10kg, Day1 and 8)) q21days x 2 cycle.
For VIT therapy responders, C5VD therapy (Cisplatin(100mg/m2 or 3.3mg/kg for <10kg, Day1) + 5-FU (600mg/m2 or 20mg/kg for <10kg, Day2)+ Vincristine (1.5mg/m2 or 0.05mg/kg for <10kg, Day2,9 and 16) + Doxorubicin (30mg/m2 or 1mg/kg for <10kg, Day1 and 2)) q21days x 6 cycles and 2 cycles of VIT therapy. Tumor resection or liver transplant perform between 2nd cycle and 10th cycle.
For VIT therapy non-responders, C5VD therapy q 21 days x 6 cycles. Tumor resection or liver transplant perform between 2nd cycle and 8th 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
| Not applicable |
Age-upper limit
| 21 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Age:21 or younger
2)Patients must be newly diagnosed with histologically-proven hepatoblastoma, except as emergency situations when a patient meets all other eligibility criteria and not reveal another pathological diagnosis.
3)ECOG score:0-2
4) Creatinine clearance or radioisotope GFR greater than or equal to 70 mL/min/1.73 m2. Or, serum creatinine within based on age/gender.
5) Total bilirubin < 1.5 x ULN for age, and SGOT or SGPT < 10 x ULN for age.
6) ANC>750/mm3, PLT>75,000/mm3
7) Shortening fraction greater than or equal to 27% by echocardiogram, or Ejection fraction greater than or equal to 47% by radionuclide angiogram (MUGA).
8) Serum triglyceride level less than or equal to 300mg/dL and serum cholesterol level less than or equal to 300 mg/dL
9) Random or fasting blood glucose within the ULN for age
10) Pulmonary function tests is normal
11) Patient have normal neurologic function.
12) PT<1.2xULN
Key exclusion criteria
1) Patients that have been previously treated with chemotherapy for hepatoblastoma or other hepatoblastoma-directed therapy
2)Any prior chemotherapy
3)Currently receiving another therapy with other investigational drug
4)Currently receiving another anticancer agents
5)Previously received a solid organ transplant
6) Uncontrolled infection
7) Pregnant or breast feeding
8) Childbearing potential, not practicing adequate contraception
9)Receiving corticosteroids
10)Receiving enzyme inducing anticonvulsants
11)Receiving CYP3A4 inducers or inhibitors
12)Receiving therapeutic anticoagulants
13)Receiving ACE inhibitors
14) Patients who have had a major surgical procedure within 6weeks prior to registration
15) Patient who is judged inappropriate to participate in this study by the investigators.(ex; Patients don't sign informed concent.)
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | Howard |
| Middle name | |
| Last name | Katzenstein |
Organization
Ingram Cancer Center
Vanderbilt University
Division name
Division of Hematology/Oncology
Zip code
37232-6310
Address
2220 Pierce Avenue, Room 397 PRB
TEL
+1-626+447+0064
HelpDesk@childrensoncologygroup.org
Public contact
Name of contact person
| 1st name | Eiso |
| Middle name | |
| Last name | Hiyama |
Organization
Hiroshima University Hospital
Division name
Department of Pediatrics surgery
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima-city
TEL
082-257-5416
Homepage URL
ahep0731@kuhs.ac.jp
Sponsor or person
Institute
Children's Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hiroshima University Hospital IRB
Address
1-2-3 Kasumi, Minami-ku, Hiroshima-city
Tel
082-257-5596
eiso@hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00980460
Org. issuing International ID_1
National Cancer Institute (NCI)
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
広島大学病院（広島県）、日本大学医学部附属板橋病院（東京都）、鹿児島大学病院（鹿児島県）、国立がん研究センター中央病院（東京都）、福島県立医科大学附属病院（福島県）、九州大学病院（福岡県）、国立成育医療研究センター（東京都）、静岡県立こども病院（静岡県）、静岡県立静岡がんセンター（静岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 18 | 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
3
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
| 2015 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2015 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022902
