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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form. Who Should NOT Join This Trial: Patients with one or more critical organs failure such as heart, brain, kidney failure. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

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.

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China