Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
Recruiting now · Phase 1
Conditions studied: Neuroblastoma
In brief
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.
Key facts
- Study ID
- NCT06995872
- Run by
- National Cancer Institute (NCI)
- People needed
- 40
- Starts
- 2025-10-21
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-07-20
Who can join
Age: 3 and older, up to 35. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Presence of pericardial effusion.
- Chronic immunosuppression (physiologic steroid supplementation is allowed but any chronic immunosuppressant like steroids or other modulators are not allowed)
- Major surgery within 4 weeks prior to initiation of study therapy
- Current/active human immunodeficiency virus (HIV) infection, as measured by seropositivity for HIV antibody.
- Current/active HBV/HCV infection as measured by seropositivity for Hepatitis C or positive for Hepatitis B surface antigen (HBsAg).
- History of severe, immediate hypersensitivity reaction attributed to compounds of similar chemical or biological composition to irinotecan and temozolomide used in study.
- Participants with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.
- Positive serum or urine beta-HCG pregnancy test performed at screening due to the teratogenic effects of chemotherapy.
- Participants with a prior or concurrent malignancy whose natural history or treatment with the safety or efficacy assessment of the investigational regimen.
- Participants with >= grade 2 diarrhea at the time of entry.
- Participants who are unable to tolerate oral/nasogastric/gastrostomy medications. Additionally, participants with significant malabsorption will not be eligible for this trial.
- Participants with uncontrolled infection.
- Participants with a history of Grade 4 allergic reactions to anti-GD2 antibodies or reactions that required permanent discontinuation of the anti-GD2 therapy.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.