Actively Recruiting
UGT1A1 Genotype-drien Phase I Study of Irinotecan in VIT Regimen for the Treatment of Pediatric R/R Solid Tumors
Led by Sun Yat-sen University · Updated on 2025-01-06
39
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Irinotecan is a commonly used salvage chemotherapy drug for children with relapsed and refractory solid tumors. Common dose-limiting toxicities of irinotecan include abdominal pain and diarrhea. Studies have shown that patients with UGT1A16 gene mutations have a higher incidence of these side effects, thereby limiting the dosage of irinotecan. The combination of irinotecan with temozolomide and vincristine is a common salvage chemotherapy regimen for children with relapsed and refractory solid tumors. Currently, the recommended dose of irinotecan is 50mg/m², but there is still significant room for improvement in the efficacy of VIT for these children. Whether patients with wild-type UGT1A16 can further increase the dosage of irinotecan, thereby enhancing the efficacy of the VIT regimen, is the focus of our research.
CONDITIONS
Official Title
UGT1A1 Genotype-drien Phase I Study of Irinotecan in VIT Regimen for the Treatment of Pediatric R/R Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Younger than 18 years old
- Diagnosed with relapsed or refractory childhood solid tumors confirmed by pathology
- Wild-type UGT1A1*6 genotype (T/T) confirmed by testing
- At least 3 weeks since last myelosuppressive chemotherapy
- At least 6 months since hematopoietic stem cell transplantation
- At least 2 weeks since local radiotherapy or 6 months since craniospinal/extensive pelvic radiotherapy
- At least 6 weeks since extensive bone marrow radiotherapy
- At least one measurable tumor lesion per RECIST criteria
- Karnofsky or Lansky performance score of 50 or higher
- Expected survival of 6 months or more
- Fully recovered from acute toxic effects of prior chemotherapy
- Blood counts meeting specified minimum levels (ANC, platelets, hemoglobin)
- Liver and kidney function within defined limits
- Able to adhere to outpatient treatment and clinical visits
- Parents/guardians able to consent and child able to assent if applicable
You will not qualify if you...
- Prior chemotherapy with irinotecan combined with temozolomide and vincristine or progression after irinotecan or temozolomide treatment
- Use of P450 enzyme-inducing antiepileptic drugs
- Receiving other chemotherapy, radiotherapy, or granulocyte colony-stimulating therapy during the study
- Positive for hepatitis B surface antigen
- Infected with HIV or syphilis
- Previous organ transplantation
- Uncontrolled active bacterial, viral, or fungal infections including Clostridium difficile
- Allergic to dacarbazine or cephalosporin drugs
- Requiring high-dose dexamethasone treatment
- Severe neurological or psychiatric disorders including epilepsy or autism
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yizhuo Zhang
CONTACT
J
Juan Juan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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