Status:
RECRUITING
Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer
Lead Sponsor:
Yang Li
Collaborating Sponsors:
Ruijin Hospital
Conditions:
Pediatric Cancer
Li-Fraumeni Syndrome
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
Brief 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.
Detailed Description
Germline mutation on tumor suppressor p53 can result in Li-Fraumeni syndrome (LFS), a hereditary condition characterized by the development of multiple cancer types, often at a young or middle age. LF...
Eligibility Criteria
Inclusion
- Pathological diagnosis basis of malignant tumor；
- Patients not more than 18 years old;
- 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);
- There are measurable lesions;
- Guardians agreed and signed informed consent.
Exclusion
- Patients with one or more critical organs failure such as heart, brain, kidney failure.
Key Trial Info
Start Date :
December 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 14 2031
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06088030
Start Date
December 13 2023
End Date
December 14 2031
Last Update
January 3 2024
Active Locations (1)
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1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120