DCV in the Treatment of Recurrence & Refractory Childhood Solid Tumors

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Unrecognized Condition

Clinical Trial Details

NCT number	NCT04213612
Study type	Interventional
Source	Sun Yat-sen University
Contact	Yizhuo Zhang
Phone	02087342459
Email	zhangyzh@sysucc.org.cn
Status	Not yet recruiting
Phase	Phase 1
Start date	December 30, 2019
Completion date	November 30, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

DCV in the Treatment of Recurrence and Refractory Childhood Solid Tumors

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms