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

Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study ID
NCT06933394
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Months - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • Arsenic trioxide — DRUG
    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 — DRUG
    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 — DRUG
    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)).

Study Details

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.

Key Dates

First listed
Apr 18, 2025
Start date
May 1, 2025
Status verified
Apr 2025
Primary completion
May 1, 2031
Completion
May 1, 2031

Study Design

Enrollment
92 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experiment group

Primary Outcome Measure

Complete remission rate (CRR) [ Time Frame: Four weeks after ATO-combined chemotherapy ]

Central Contacts

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