MedPath

Treatment of Children with All Stage of Hepatoblastoma with Temsirolimus(IND#122782, NSC#683864) Added to High Risk Stratum Treatment

Phase 3
Conditions
Hepatoblastoma
Registration Number
JPRN-UMIN000019840
Lead Sponsor
Children's Oncology Group
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
3
Inclusion Criteria

Not provided

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.)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
response rate at the end of 2nd cycle
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath