Actively Recruiting
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
Led by Yang Li · Updated on 2024-01-03
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yang Li
Lead Sponsor
R
Ruijin Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of arsenic trioxide combined with chemotherapy for treating pediatric cancer patients who have p53 mutations. These mutations are linked to Li-Fraumeni syndrome, a hereditary condition that greatly increases the risk of developing multiple cancers at a young age. Current treatments for this condition are limited and often involve DNA-damaging therapies that can lead to additional tumors. This study aims to explore a treatment that targets mutant p53 without causing DNA damage, which could offer new options for affected children. Participants will first receive their standard first-line chemotherapy for their specific cancer type. If the cancer does not respond or remains stable, arsenic trioxide will be added to their existing chemotherapy regimen starting on the third day of each treatment cycle. The arsenic trioxide is given intravenously at a dose based on body weight, over six hours daily for ten days during each cycle. This approach will be tested in a single-arm, multi-center trial that also includes laboratory experiments to confirm arsenic trioxide’s ability to restore p53 function in the patient’s specific mutation. During the study, participants will be closely monitored with regular assessments of their cancer’s response to treatment, including measurements of tumor size four weeks after starting arsenic trioxide combined therapy. Researchers will also track progression-free survival, overall survival, and any adverse events for up to three years. Guardians will provide informed consent, and patients must have measurable tumors and confirmed p53 mutations that respond to arsenic trioxide in lab tests. This careful monitoring aims to ensure safety and gather important data on the treatment’s impact over time.
CONDITIONS
Brief Title
Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathological diagnosis of malignant tumor
- Patient is 18 years old or younger
- Presence of either germline or somatic p53 mutations shown to be partially or completely restored by arsenic trioxide in lab tests
- Measurable lesions present
- Guardians have agreed and signed informed consent
You will not qualify if you...
- Patients with failure of one or more critical organs such as heart, brain, or kidney
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Varies depending on treatment response
Participants first receive the corresponding first-line chemotherapy regimen. If disease progression or stable disease is observed, arsenic trioxide (ATO) will be added to the chemotherapy regimen starting on the third day of each treatment cycle.
Visits on each treatment cycle including chemotherapy and ATO administration
Duration - Up to 3 years
Participants are monitored for progression-free survival, overall survival, and incidence of adverse events for up to 3 years after treatment.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
Y
Yang Li, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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