Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer

NCT06088030 · tracked via the Priya Life Science China tracker

Sponsor

Yang Li

Phase

Phase 2

Started

2023-12-13

Last updated

2024-01-03

Condition(s) studied

Pediatric CancerLi-Fraumeni Syndromep53 Mutations

Investigational drug(s) / intervention(s)

Arsenic trioxide

Arsenic trioxide: Patients should be treated with the corresponding first-line chemotherapy regimen first, for example: Neuroblastoma: CAV (cyclophosphamide, pinarubicin, vincristine), PVP (cisplatin, etoposide) ,CT (cyclophosphamide, topotecan).If patients was evaluted as PD/SD after treatments, arsenic trioxide (ATO) will be administered 0.18mg/kg per day over six hours IV daily for ten days in combination with previous chemotherapy regimen on the third day of each treatment cycle. Other pediatric tumors with TP53 mutations not mentioned above will have similar treatment regimens. If the efficacy of the conventional standard chemotherapy regimen is evaluated as PD/SD, then the next course of treatment will be combined with ATO on the basis of the standard chemotherapy regimen.

Study summary

This prospective, single-arm, multi-center clinical trial aims to explore and evaluate the efficacy and safety of arsenic trioxide combined with chemotherapy for pediatric cancer with p53 mutation.

Eligibility

Sex

ALL

Min age

—

Max age

18 Years

Healthy volunteers

Inclusion Criteria: 1. Pathological diagnosis basis of malignant tumor； 2. Patients not more than 18 years old; 3. Patient has either germline or somatic p53 mutations, which was shown to be partially/completely restored to function by ATO in in vitro experiments (http://www.rescuep53.net); 4. There are measurable lesions; 5. Guardians agreed and signed informed consent. Exclusion Criteria: Patients with one or more critical organs failure such as heart, brain, kidney failure.

Primary outcome measure(s)

Objective response rate — Four weeks after ATO-combined chemotherapy
Objective response rate

Trial sites (1)

Facility	City	Region	Status
Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	Recruiting

More Yang Li trials in China

Phase II Study of Combined Chemotherapy With Arsenic Trioxide in Stage 4/M Neuroblastoma Active, not recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06088030 on ClinicalTrials.gov ↗ ← All trials in China