Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma

NCT06995872 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 10001842001842-C
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Neuroblastoma

Keywords

Irinotecan; Temozolomide; ch14.18; IL-15; Neuroblastoma; Dinituximab

Outcome Measures

Primary Outcomes (1)

• Assess the safety and determine the MTD of rhIL-15 combined with dinutuximab/temozolomide/irinotecan

  Assessment of AEs and DLTs in participants.

  6 weeks

Secondary Outcomes (2)

• Anti-tumor activity

  6 months

• Pharmacokinetics

  3 weeks

Study Arms (1)

Arm 1

EXPERIMENTAL

Participants will receive dinutuximab at a dose of 17.5 mg/m2/day x 4 days, in combination with escalating doses of rhIL-15 and fixed dose irinotecan and temozolomide.

Drug: rhIL-15; Drug: Dinituximab; Drug: Temozolomide; Drug: Irinotecan Hydrochloride

Interventions

rhIL-15 DRUG

rhIL-15 will be given at a dose of 0.13-2 mcg/kg/day (based on dose level) as a continuous IV infusion for 5 days each cycle.

Arm 1

Dinituximab DRUG

Dinituximab will be given at a dose of 17.5 mg/m\^2/dose by IV on days 2-5 of each cycle.

Arm 1

Temozolomide DRUG

Temozolomide will be given orally (PO) at a dose based on weight on days 1-5 of each cycle beginning with cycle 2.

Arm 1

Irinotecan Hydrochloride DRUG

Irinotecan will be given at a dose of 50 mg/m\^2/dose by IV on days 1-5 of each cycle beginning with cycle 2.

Arm 1

Eligibility Criteria

• Age: 3 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neuroblastoma

Interventions

Temozolomide; Irinotecan

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Camptothecin; Alkaloids

Study Officials

• Hong Ha Rosa Nguyen, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hong Ha Rosa Nguyen, M.D.

CONTACT

(443) 902-3243; hongharosa.nguyen@nih.gov

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: May 30, 2025
• Study Start: October 21, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04-29

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available as soon as possible or at the time of associated publication. Data not published in a manuscript will be shared via public source once the data set completes QC.
• Access Criteria: The scientific data will be findable by key words or MeSH terms used during publication of manuscripts.

Locations

US (1)