NCT04213612

DCV in the Treatment of Recurrence and Refractory Childhood Solid Tumors

Phase I Study of Pegylated Liposomal Doxorubicin Combined With Cyclophosphamide and Vincristine in Treatment Progress, Relapse, and Refractory Solid Tumors in Children

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

Purpose of Phase I: the main purpose: To evaluate the safety of PLD in combination with cyclophosphamide, vincristine, regenerative, and refractory solid tumors in children, including dose absorption toxicity (DLT) Secondary purpose: * determine the appropriate maximum tolerated dose (MTD) and /or PLD for further clinical studies in this patient population; * Describe the antitumor activity of PLD combined with cyclophosphamide and vincristine in children with advanced solid tumors or primary CNS tumors; Exploratory purpose: Effectiveness of PLD combined with cyclophosphamide and vincristine in treatment progress, relapse, and refractory solid tumors in children.

Conditions

• Unrecognized Condition

Interventions

Type	Name	Description
DRUG	pegylated liposomal doxorubicin, cyclophosphamide, vincristine,	PLD 40mg/m2 ; PLD 50mg/m2 ; PLD 60mg/m2 ; Maximum tolerated dose； Dose-limiting toxicity

Timeline

• Start date: 2019-12-30
• Primary completion: 2020-08-30
• Completion: 2020-11-30
• First posted: 2019-12-30
• Last updated: 2019-12-30