Actively Recruiting
A Phase II Trial of Chidamide Combined With Dinutuximab Beta, Irinotecan, and Temozolomide for Refractory or Relapsed Neuroblastoma in Children
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2026-06-04
27
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a Phase II study focusing on children diagnosed with relapsed or refractory neuroblastoma, a type of cancer that affects nerve tissue. Researchers are evaluating the safety and effectiveness of a combination of four drugs: Chidamide, Dinutuximab Beta, Irinotecan, and Temozolomide. The goal is to understand how well this treatment controls the cancer and to observe any side effects in these young patients. The treatment involves Chidamide given orally at a dose of 5 mg per 10 kg body weight (up to 30 mg) twice weekly. It is taken on Days 0, 3, 7, and 10 in a three-week cycle, with two weeks on treatment followed by one week off. Chidamide is started one day before chemotherapy begins. This combination therapy is being studied as a potential option for children who have not responded adequately to previous treatments. Participants will be closely monitored from enrollment through 10 weeks of treatment. The study will assess the objective response rate, progression-free survival, event-free survival, duration of response, and overall survival during this period. Safety evaluations include monitoring side effects and laboratory tests to track bone marrow, kidney, liver, heart, and lung functions. Participants must comply with scheduled visits and assessments throughout the treatment phase.
CONDITIONS
Brief Title
Phase II Study of Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for Refractory/Relapsed Neuroblastoma in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with histologically diagnosed neuroblastoma according to INRG classification or Chinese pediatric neuroblastoma guidelines
- Patients with relapsed or refractory neuroblastoma
- Prior treatment with epigenetic drugs or GD2 monoclonal antibodies does not exclude participation
- Presence of evaluable disease
- Performance status: Lansky score 50%, Karnofsky score 50%, or ECOG score 3
- Life expectancy of at least 12 weeks
- Bone marrow function meeting specified platelet, ANC, and hemoglobin levels depending on bone marrow disease presence
- No significant proteinuria; specific protein-to-creatinine ratios or 24-hour protein excretion limits if proteinuria detected
- Serum creatinine 1.5 times ULN or adequate glomerular filtration rate if higher
- Hepatic function within specified AST, ALT, and bilirubin limits, adjusted for liver metastases
- Cardiac function with left ventricular shortening fraction 29% on echocardiogram
- Coagulation parameters within specified INR and APTT limits; stable anticoagulation allowed
- Oxygen saturation above 94% on room air
- Ability to comply with study visit schedule and protocol requirements
You will not qualify if you...
- Patients with Grade 3 or higher toxicities involving hearing, hematologic, hepatic, or renal disorders
- Patients with Grade 2 or higher neurotoxicity
- Major surgery within 14 days before first dose
- Severe infection requiring IV antibiotics, antifungals, or antivirals within one week before treatment or unexplained fever above 38.56C during screening
- Congenital or acquired immunodeficiency, active HIV, or active hepatitis not meeting inclusion criteria
- Any condition that jeopardizes safety, confounds results, or impedes study completion
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 weeks
Participants receive Chidamide combined with Dinutuximab Beta, Irinotecan, and Temozolomide in repeated 3-week cycles, with Chidamide administered twice per week for two weeks followed by one week off.
Weekly visits for up to 10 weeks
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
Research Team
Y
Yan Jin
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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