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Arsenic Trioxide With MAPK Inhibitors and Chemotherapy for Stage 4/M Neuroblastoma
Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Summary
This prospective, single-arm, multi-center clinical trial aims to explore and evaluate the efficacy and safety of the combination therapy involving arsenic trioxide, MAPK inhibitors, and chemotherapy for stage 4/M neuroblastoma.
Official title: A Prospective, Single-arm, Multicentre Phase II Clinical Study of Arsenic Trioxide in Combination With Chemotherapy and MAPK Pathway Inhibitors for Stage 4/M Neuroblastoma
Key Details
Gender
All
Age Range
18 Months - 18 Years
Study Type
INTERVENTIONAL
Enrollment
92
Start Date
2025-05-01
Completion Date
2031-05-01
Last Updated
2025-04-18
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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)).
Locations (1)
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China