Actively Recruiting
Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
Led by National Cancer Institute (NCI) · Updated on 2026-05-06
40
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 3 and 35 years at enrollment
- Histologic confirmation of neuroblastoma
- Relapsed or refractory neuroblastoma after frontline chemotherapy and at least one salvage treatment
- Evaluable disease by imaging or bone marrow studies per International Neuroblastoma Response Criteria
- Measurable tumors on MRI or CT (>=10 mm in one dimension) or MIBG/PET scan positive lesion
- Participants with soft tissue disease not MIBG-avid must have biopsy confirmation
- Bone marrow disease confirmed by biopsy allowed
- No active central nervous system disease
- Recovered from adverse events of prior therapies
- Prior dinutuximab/temozolomide/irinotecan therapy allowed
- Recovered from myelosuppressive chemotherapy
- Sufficient clearance time for non-myelosuppressive agents
- Toxicity from prior anti-GD2 antibody therapy recovered to grade <=1
- Recovered from radiation-induced myelosuppression
- Met hematologic and other criteria after stem cell transplant or 131I-MIBG therapy
- Karnofsky score >=50 (age >=16) or Lansky score >=50 (age <16)
- Adequate organ and marrow function (neutrophils >=750/mcL, platelets >=75,000/mcL, bilirubin <=2x ULN, AST/ALT <=3x ULN, creatinine within age-specific limits, cardiac ejection fraction >=52%, oxygen saturation >92% on room air)
- Agreement to use effective contraception or abstinence if of childbearing/fathering potential
- Not nursing or agree to discontinue nursing during study
- Ability to understand and sign informed consent
You will not qualify if you...
- Presence of pericardial effusion
- Chronic immunosuppression with steroids or other agents (physiologic steroid supplementation allowed)
- Major surgery within 4 weeks before starting study therapy
- Active HIV infection
- Active hepatitis B or C infection
- Severe immediate hypersensitivity to irinotecan or temozolomide
- Uncontrolled illness or conditions posing hazards to participation
- Positive pregnancy test
- Prior or concurrent malignancy interfering with study evaluation
- Grade 2 or higher diarrhea at entry
- Inability to tolerate oral/nasogastric/gastrostomy medications or significant malabsorption
- Uncontrolled infection
- History of grade 4 allergic reactions or therapy discontinuation due to anti-GD2 antibodies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
H
Hong Ha Rosa Nguyen, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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