Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma

PHASE2RecruitingINTERVENTIONAL
Enrollment

92

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

May 1, 2031

Study Completion Date

May 1, 2031

Conditions
Neuroblastoma
Interventions
DRUG

Arsenic trioxide

Patients will receive 9 cycles of chemotherapy. ATO dosing: Arsenic trioxide(ATO) is administered 0.18mg/kg per day over eight hours IV daily for ten days. Patients will receive ATO alone on days 1-2 and combined with conventional induction chemotherapy on days 3-10.

DRUG

MAPK inhibitors

"The dosage of MAPK inhibitors is adjusted based on the specific drug. For example, Trametinib is used as follows: Trametinib will be administered daily from Cycle 5 until the end of induction chemotherapy. Patients start at Dose Level I; if no hematologic toxicity or severe drug-related complications occur after 1 cycle, the dose is escalated to the next level, otherwise, it is maintained. Dose Level I: 0.016 mg/kg/day (\<6 years) or 0.012 mg/kg/day (\>6 years), po. qd. Dose Level II: 0.024 mg/kg/day (\<6 years) or 0.018 mg/kg/day (\>6 years), po. qd. Dose Level III: 0.032 mg/kg/day (\<6 years) or 0.025 mg/kg/day (\>6 years), po. qd.~The dosages of other MAPK inhibitors should be modified according to their respective recommended therapeutic guidelines."

DRUG

Chemotherapy

"The conventional chemotherapy regimens are as follows:~Cycles 1, 2, 4, and 6 follow the CAV regimen (cyclophosphamide(1.2g/m2.d, d3-d4), pirarubicin(25mg/m2.d,d3-d5), vincristine(0.022mg/kg.d or 0.67mg/m2.d,d3-d5)).~Cycles 3, 5, and 7 follow the PVP regimen (cisplatin(50mg/m2.d, d3-d6), etoposide(200mg/ m2.d, d3-d5)).~Cycles 8 and 9 follow the CT regimen (cyclophosphamide(1.2g/m2.d, d3-d4), topotecan(2mg/m2.d, d3-d5))."

Trial Locations (1)

510120

RECRUITING

Sun Yat-sen Memorial Hospital, Guangzhou

All Listed Sponsors
lead

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER