RecruitingPhase 1Phase 2NCT05027386

Apatinib Mesylate Combined With IT Regimen for the Treatment of Recurrent or Refractory Pediatric Neuroblastoma: A Single-arm, Phase I/II，Multi-center, Clinical Study.

Sponsor

Sun Yat-sen University

Enrollment

125 participants

Start Date

Aug 26, 2021

Study Type

INTERVENTIONAL

Conditions

Neuroblastoma

Summary

The survival rate of recurrent and refractory pediatric neuroblastoma is low and the prognosis is poor. Apatinib mesylate is a highly selective small-molecule vasoendothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor. Apatinib mesylate has been shown to be safe and effective in recurrent or refractory pediatric neuroblastoma in Sun Yat-sen University Cancer Center. Apatinib mesylate combined with IT regimen is expected to further improve the efficacy and survival rate of recurrent or refractory pediatric neuroblastoma.

Eligibility

Min Age: 5 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase I/II study tests a targeted drug called apatinib (which cuts off blood supply to tumors) combined with standard chemotherapy (irinotecan and temozolomide) in children and teenagers with neuroblastoma — a type of nerve cell cancer — that has come back or stopped responding to prior treatment. **You may be eligible if...** - You are between 5 and 18 years old - You have neuroblastoma confirmed by tissue testing - Your cancer has relapsed or failed to respond to first-line treatment - You have recovered from side effects of prior chemotherapy - Your expected survival is more than 12 weeks and you have measurable tumors **You may NOT be eligible if...** - You have not yet tried first-line treatment - You have not fully recovered from the side effects of recent chemotherapy - You received another experimental drug within the past 28 days - Your blood counts or organ function do not meet the required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApatinib, Irinotecan, Temozolomide

In the Phase I stage, apatinib was administered using a 3+3 dose escalation design with three dose cohorts. The IT regimen was maintained at fixed doses, with patients receiving up to 6 cycles of chemotherapy. The recommended Phase II dose (RP2D) was determined from the Phase I dose-escalation phase. In the Phase II stage, the study included an apatinib combination therapy phase and an apatinib maintenance therapy phase. During the combination therapy phase, apatinib was administered at the RP2D in combination with the IT regimen (at fixed doses) for up to 6 cycles. In the maintenance therapy phase, apatinib was administered orally as a single agent at the RP2D until disease progression or intolerable toxicity occurred.