Clinical trial

Clinical Research on Efficacy and Safety of Arsenic Trioxide Combined With Chemotherapy in p53-mutated Pediatric Cancer Patients：A Prospective，Single-arm, Multi-center Study

Name

SYS-202309

Description

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.

Trial arms

Trial start

2023-12-13

Estimated PCD

2031-12-14

Trial end

2031-12-14

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Arsenic trioxide combined chemotherapy

Other names:

ATO

Size

Primary endpoint

Objective response rate

Four weeks after ATO-combined chemotherapy

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

Updated at

2024-01-03

1 organization

1 product

3 indications

Organization

Product

Indication

Indication

Indication