DCV in the Treatment of Recurrence and Refractory Childhood Solid Tumors
Status:
Not yet recruiting
Trial end date:
2020-11-30
Target enrollment:
Participant gender:
Summary
Doxorubicin is an anthracycline antibiotic that is part of the standard treatment for many
pediatric malignancies, but its long-term cardiotoxicity cannot be ignored. Without affecting
overall survival, in order to improve the quality of life of childhood tumor survivors and
reduce cardiotoxicity, drugs with less cardiotoxicity should be selected; compared with
ordinary doxorubicin, PEGylated doxorubicin (PLD ) The biggest advantage is the low
cardiotoxicity.
PEGylated doxorubicin (Caelyx®) has undergone a Phase I dose climbing clinical trial in
children with solid tumors. The drug is safe by testing PK. The results of Phase II clinical
studies of Caelyx® in children with progressive soft tissue sarcoma show that the drug is
safe. Domestically produced PEGylated doxorubicin has no data on childhood tumors in China.
Therefore, we plan to conduct a phase I study in pediatric solid tumors of pegylated
doxorubicin combined with cyclophosphamide, vincristine, relapsed, and refractory childhood
solid tumors. Maximum tolerated dose and effectiveness of stellate in children with solid
tumors, thus laying the foundation for future phase II / III clinical studies