Chidamide-Dinutuximab Beta-Irinotecan-Temozolomide for relapsed or refractory neuroblastoma in children

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 Phase II study evaluates the safety and effectiveness of a four-drug regimen (chidamide, dinutuximab beta, irinotecan, and temozolomide) in children with relapsed or refractory neuroblastoma. Eligible patients have evaluable disease and adequate organ function, with performance status allowing participation. The study focuses on tumor response as the primary endpoint while monitoring adverse events closely as a key secondary objective. Prior exposures to certain agents do not exclude eligibility. The trial is conducted at Tianjin Medical University Cancer Institute and Hospital in China under a lead sponsor with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 0-18 years at enrolment.
2. Histologically diagnosed neuroblastoma defined as high-risk according to the International Neuroblastoma Risk Group classification or Chinese consensus/guideline risk classification.
3. Relapsed or refractory neuroblastoma. Relapse is defined as any recurrence of neuroblastoma. Refractory disease is defined as inadequate response to prior therapy, including partial response, minor response or stable disease, followed by progression.
4. Prior exposure to histone deacetylase inhibitors, DNA methylation inhibitors or GD2 monoclonal antibodies does not preclude eligibility.
5. Presence of evaluable disease.
6. Performance status of Lansky score \>=50%, Karnofsky score \>=50% or ECOG performance status \<=3.
7. Life expectancy \>=12 weeks.
8. Adequate bone marrow function: for patients without bone marrow disease, platelet count \>=75 x 10\^9/L, absolute neutrophil count \>=0.75 x 10\^9/L and haemoglobin \>=8 g/dL with transfusion permitted; for patients with bone marrow disease, platelet count \>=50 x 10\^9/L, absolute neutrophil count \>=0.5 x 10\^9/L and haemoglobin \>=8 g/dL with transfusion permitted.
9. Renal function without clinically significant proteinuria. If urine dipstick protein is \>=2+, protein:creatinine ratio must be \<0.5 or 24-hour protein excretion must be \<0.5 g.
10. Serum creatinine \<=1.5 x upper limit of normal or calculated glomerular filtration rate \>=60 mL/min/1.73 m2 if serum creatinine is higher.
11. Adequate liver function: AST or ALT \<=2.5 x upper limit of normal and total bilirubin \<=1.5 x upper limit of normal; in the presence of hepatic metastases, AST or ALT \<=5 x upper limit of normal and total bilirubin \<=2.5 x upper limit of normal.
12. Cardiac shortening fraction \>=29% on echocardiography.
13. Coagulation function with INR \<=1.5 and APTT \<=1.5 x upper limit of normal for age if not receiving anticoagulation; anticoagulation is permitted if INR or APTT is within the therapeutic range and the dose has been stable for at least 2 weeks before registration.
14. Oxygen saturation \>94% without supplemental oxygen. Ability to comply with the visit schedule and other protocol requirements.

Exclusion Criteria:

1. Patients with CTCAE v5.0 Grade 3 or higher toxicities involving hearing impairment, hematologic disorders, hepatic, or renal diseases.
2. Patients with CTCAE v5.0 Grade 2 or higher neurotoxicity.
3. Major surgical procedure within 14 days prior to the first dose of the study drug.
4. Severe infection (requiring IV antibiotics, antifungals, or antivirals) within one week prior to treatment, or unexplained fever \>38.5°C during screening or before the first dose.
5. Congenital or acquired immunodeficiency, or active infectious diseases such as HIV or active hepatitis (with transaminase levels not meeting inclusion criteria; HBV DNA ≥1000 IU/mL; HCV RNA ≥1000 IU/mL). Chronic HBV carriers with HBV DNA \<2000 IU/mL may be enrolled if they receive concurrent antiviral therapy during the trial.
6. Any concomitant condition that, in the investigator's judgment, seriously jeopardizes patient safety, may confound the study results, or could impede the patient's completion of the study.

Where it's running

• Tianjin Medical University Cancer Institute & Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Yan Jin
• Email: myyaner520@163.com
• Phone: +8613212163398

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using NK cells to treat high-risk neuroblastoma in children

  This study is testing if injections of special immune cells can help children aged 2 to 16 with tough-to-treat neuroblastoma feel better and improve their chances of recovery.

  Recruiting Phase 1 Kian Immune Cell Company · Tehran · NCT06674265

• Targeted radiopharmaceutical radiotherapy for relapsed or refractory neuroblastoma

  A short, patient-friendly test of [211At]MABG radiotherapy to see if it is safe and tolerable in kids and young patients with relapsed or hard-to-treat neuroblastoma.

  Recruiting Early Phase 1 Sichuan University · Chengdu, Sichuan · NCT07767630

• Dinutuximab-beta with chemotherapy in newly diagnosed high-risk neuroblastoma

  This pilot study tests whether adding the antibody dinutuximab-beta to standard induction chemotherapy is safe and helps shrink tumors in kids and young adults with newly diagnosed high-risk neuroblastoma.

  Recruiting at 2 sites Phase 1 Chang Gung Memorial Hospital · Taipei, Taiwan and 1 other locations · NCT07688252

• Iberdomide added to chemoimmunotherapy for relapsed or refractory neuroblastoma

  This study tests whether adding iberdomide to a chemoimmunotherapy regimen helps children and young people with relapsed, refractory, or progressing neuroblastoma.

  Recruiting at 4 sites Phase 1/2 National Cancer Institute (NCI) · Oakland, California and 3 other locations · NCT07437963

• Chemoimmunotherapy with autologous NK‑cell therapy for children with refractory or relapsed high‑risk neuroblastoma and ganglioneuroblastoma

  This treatment will test whether adding a child's own expanded natural killer (NK) cells to chemoimmunotherapy helps children with refractory or relapsed high‑risk neuroblastoma or ganglioneuroblastoma respond better.

  Recruiting Phase 3 Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Moscow · NCT07375563

• MIBG SPECT/CT and somatostatin receptor PET for diagnosing and staging neuroblastoma

  This study tests whether combining 123I‑MIBG SPECT/CT and somatostatin receptor PET improves detection, staging, and identification of PRRT candidates among children with suspected or confirmed neuroblastoma.

  Recruiting Nanjing First Hospital, Nanjing Medical University · Nanjing, Jiangsu · NCT07064746

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.