Pediyatrik Nüks/Dirençli Solid Tümörlerin Tedavisinde VIT Rejiminde Irinotecan'ın UGT1A1 Genotipine Dayalı Faz 1 Çalışması

Sade dilde özet

Bu çalışma, çocuklarda nüks etmiş veya tedaviye dirençli solid tümörlerin (solid tumors) tedavisinde Irinotecan, Temozolomide ve Vincristine ilaçlarını içeren VIT rejimini, UGT1A1 genotipine göre değerlendiriyor. Çalışmaya, 18 yaşından küçük, UGT1A1 testi yaban tip (T/T) olan ve ölçülebilir hastalığı bulunan çocuklar katılabiliyor. Faz 1 aşamasında yürütülmekte olup halen katılımcı almaktadır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 1 (Phase 1)

Durum

Katılımcı alıyor

Sponsor

Sun Yat-sen University

Müdahale

Irinotecan (CPT-11), Temozolomide (TMZ), Vincristine

Başlangıç

01.01.2022

Tahmini bitiş

01.12.2025

Ülkeler

China

İlgili genler

Merkezler

• Guangzhou, China

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

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.