Using irinotecan to treat children with relapsed solid tumors based on their UGT1A1 gene

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 clinical trial investigates the use of irinotecan in combination with temozolomide and vincristine for children with relapsed and refractory solid tumors who have a wild-type UGT1A1 gene. The study starts with a dose of 50mg/m² of irinotecan and escalates to a maximum of 110mg/m² to determine the maximum tolerated dose and evaluate safety. The trial will assess the objective response rate, disease control rate, progression-free survival, and overall survival to inform future studies. The goal is to enhance the efficacy of the VIT regimen for these pediatric patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \< 18 years.
2. Relapsed and refractory childhood solid tumors (pathologically confirmed). Definition of relapsed and refractory patients: 1. Patients who fail to achieve GPR or CR after first-line treatment are defined as refractory; 2. Patients who achieve CR after first-line treatment but relapse after more than 1 month are defined as relapsed.
3. Must have undergone UGT1A1\*6 genotype testing (provided free of charge by Jiangsu Hengrui Medicine Co., Ltd.), with results being wild type (T/T).
4. Patients must be at least 3 weeks post the last myelosuppressive chemotherapy and at least 6 months post hematopoietic stem cell transplantation, 2 weeks post local radiotherapy, 6 months post craniospinal or extensive pelvic radiotherapy, or 6 weeks post extensive bone marrow radiotherapy.
5. Must have at least one measurable lesion as defined by RECIST criteria;
6. Karnofsky score (for ages \> 10, see Annex I) or Lansky score (for ages ≤ 10, see Annex II) ≥ 50 points;
7. Expected survival time ≥ 6 months;
8. Patients must have fully recovered from all acute toxic effects of previous anticancer chemotherapy: a) Bone marrow suppression chemotherapy: at least 21 days post the last bone marrow suppressive chemotherapy; b) Hematopoietic growth factors: at least 14 days post the last dose of long-acting growth factor or 7 days post the last dose of short-acting growth factor;
9. For patients known not to involve the BM: a) Absolute neutrophil count (ANC) ≥ 1.0×10⁹/L; b) Non-transfused platelet count ≥ 100.0×10⁹/L; c) Hemoglobin ≥ 80 g/L;
10. Liver and kidney functions must meet the following criteria: a) Total bilirubin (conjugated + unconjugated) ≤ 1.5× upper limit of normal (ULN) for age; b) Aspartate aminotransferase (AST) ≤ 2.5×ULN (≤ 110 U/L); c) Glomerular filtration rate or creatinine clearance ≥ 70 mL/min/1.73 m² or corresponding age-normal serum creatinine; d) Serum albumin ≥ 20 g/L.
11. Capable of adhering to outpatient treatment, laboratory monitoring, and necessary clinical visits during the study period;
12. Parents/guardians of children or adolescent subjects must be able to understand, consent to, and sign the informed consent form (ICF) and applicable child consent forms before initiating any protocol-related procedures; if parents/guardians agree, subjects must be capable of expressing consent (when applicable).

Exclusion Criteria:

1. Patients who have previously received chemotherapy with irinotecan combined with temozolomide and vincristine, or patients who have progressed after receiving treatment with irinotecan or temozolomide;
2. Patients receiving P450 enzyme-inducing antiepileptic drugs (antiepileptic drugs affect the clearance of irinotecan);
3. During the study period, patients must not receive any other chemotherapy, radiotherapy, or granulocyte colony-stimulating therapy;
4. Patients positive for hepatitis B surface antigen;
5. Patients infected with HIV or syphilis;
6. Patients who have previously undergone organ transplantation;
7. Uncontrolled active systemic bacterial, viral, or fungal infections; Clostridium difficile infection requiring treatment;
8. Patients allergic to dacarbazine or cephalosporin drugs;
9. Patients requiring high-dose dexamethasone treatment;
10. Patients with a severe history of neurological or psychiatric disorders, including epilepsy or autism.

Where it's running

• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Principal investigator: Yizhuo Zhang — SunYat Sen University Cancer Center
• Study coordinator: Yizhuo Zhang
• Email: zhangyzh@sysucc.org.cn
• Phone: 02087342460

Similar studies

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

• B7-H3 CAR T cells for relapsed or refractory solid tumors in children and young adults

  This study tests a new B7-H3 CAR T cell therapy to see if it is safe and can help kids and young adults whose solid tumors have come back or stopped responding to standard treatments.

  Recruiting Phase 1 Dana-Farber Cancer Institute · Boston, Massachusetts · NCT07358260

• Using a diabetes medication to treat pediatric brain and solid tumors

  This study is testing if a diabetes medication can be safely used with regular treatments to help children with hard-to-treat brain and solid tumors.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT05521984

• Combining cyclophosphamide, sorafenib, bevacizumab, and atezolizumab for children and young adults with relapsed solid tumors

  This will test whether giving atezolizumab and bevacizumab every three weeks together with daily cyclophosphamide and dose‑adjusted sorafenib is safe and can shrink relapsed or hard‑to‑treat solid tumors in children and young adults, including fibrolamellar carcinoma.

  Recruiting Phase 1/2 St. Jude Children's Research Hospital · Germantown, Tennessee and 1 other locations · NCT05468359

• B7-H3 CAR T-cell therapy for pediatric solid tumors

  This study is testing a new type of immune therapy using specially modified T cells to see if it can help children with tough-to-treat solid tumors.

  Recruiting Phase 1 St. Jude Children's Research Hospital · Memphis, Tennessee · NCT04897321

• New drug metarrestin for treating metastatic solid tumors

  This study is testing a new drug called metarrestin to see if it can safely shrink tumors in adults and teens with advanced solid tumors that haven't responded to other treatments.

  Recruiting at 2 sites Phase 1 National Institutes of Health Clinical Center (CC) · Fairway, Kansas and 1 other locations · NCT04222413

• Understanding rare solid tumors and their genetic factors

  This study is looking to learn more about rare solid tumors and their genetic factors by collecting samples and medical histories from people who have these tumors to help improve future treatments and prevention.

  Recruiting at 3 sites National Institutes of Health Clinical Center (CC) · Bethesda, Maryland and 2 other locations · NCT03739827

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.