OncoMatch/Clinical Trials/NCT06995872
Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
Is NCT06995872 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including rhIL-15 and Dinituximab for neuroblastoma.
Treatment: rhIL-15 · Dinituximab · Temozolomide · Irinotecan Hydrochloride — Background: Neuroblastoma is a type of cancer that causes tumors in nerves. It affects mainly infants and toddlers, and it causes about 15 percent of cancer-related deaths in children. Objective: To test a new drug (rhIL-15), combined with 3 standard cancer drugs, in people with neuroblastoma. Eligibility: People aged 3 to 35 years with neuroblastoma that did not respond or returned after standard treatment. Design: Participants will be screened. They will have a physical exam with blood and urine tests. They will have imaging scans and tests of their heart and lungs. They will have a bone marrow biopsy: A sample of tissue and fluid from inside a bone will be removed with a large needle. Participants will be treated in 21-day cycles. They may have up to 4 treatment cycles. rhIL-15 is given through a needle into a vein over 5 to 7 days during the first week of each cycle. Participants will stay in the hospital while they are receiving the rhIL-15. Starting in the second week of the second cycle, participants will receive other drugs for treating cancer. They will have no study treatments during the third week of each cycle. Participants will visit the clinic at least 2 times a week throughout all 4 treatment cycles. They will have a physical exam and blood tests during these visits. Imaging scans, bone marrow biopsy, and other tests will be repeated at the end of cycles 2 and 4. Participants will have a follow-up visit 6 months after treatment ends. This visit will include a physical exam with blood and urine tests.
Check if I qualifyExtracted eligibility criteria
Cancer type
Neuroblastoma
Prior therapy
Must have received: frontline chemotherapy
Participants must have relapsed and/or refractory disease after receiving frontline chemotherapy
Must have received: salvage therapy (dinutuximab, temozolomide, irinotecan)
at least one salvage treatment (can include dinutuximab, temozolomide, and/or irinotecan)
Cannot have received: strong CYP3A4 inducer/inhibitor
Participants who have received drugs that are strong inducers or inhibitors of CYP3A4 within 7 days before study enrollment are not eligible.
Lab requirements
Blood counts
Absolute neutrophil count >= 1000/mcL; Platelets >= 100,000/mcL (transfusion-independent)
Kidney function
Creatinine <= maximum for age OR measured creatinine clearance >= 60 mL/min/1.73 m^2
Liver function
Total bilirubin <=2 X ULN (except Gilbert's disease < 3x ULN); AST(SGOT)/ALT(SGPT) <=3 X institutional upper limit of normal
Cardiac function
Left ventricular ejection fraction >= 52 percent
Adequate Organ and Marrow Function as Defined Below: Absolute neutrophil count: >= 1000/mcL; Platelets: >= 100,000/mcL (transfusion-independent); Total bilirubin: <=2 X ULN (except in the case of participants with documented Gilbert s disease < 3x ULN); AST(SGOT)/ALT(SGPT): <=3 X institutional upper limit of normal; Creatinine: <= the maximum for age listed in the table below OR Measured creatinine clearance: >= 60 mL/min/1.73 m^2 for participants with creatinine levels above the max listed below per age; Cardiac function: Left ventricular ejection fraction >= 52 percent.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- National Institutes of Health Clinical Center · Bethesda, Maryland
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