Using arsenic trioxide with chemotherapy to treat pediatric cancer with p53 mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a prospective, single-arm, multi-center investigation aimed at evaluating the efficacy and safety of arsenic trioxide in combination with chemotherapy for treating pediatric cancers associated with p53 mutations. The study focuses on children diagnosed with Li-Fraumeni syndrome, a hereditary condition that significantly increases the risk of developing various cancers at a young age. Given the limitations of current treatment options, which often involve DNA-damaging therapies, this trial seeks to explore a novel approach that may restore the function of mutant p53 without causing further DNA damage. Participants will be closely monitored for treatment response and safety outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Yang Li, Professor
• Email: drliyang@126.com
• Phone: +8602081332456

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.