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NCT06995872 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
A Phase 1 study of Neuroblastoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT06995872: Recruiting Phase 1 study of Neuroblastoma, sponsored by National Cancer Institute (NCI).
NCT06995872 is a Phase 1 study of Neuroblastoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 34 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06995872, a Phase 1 study of Neuroblastoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Assessment of AEs and DLTs in participants.
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG Irinotecan Hydrochloride
- DRUG rhIL-15
- DRUG Dinituximab
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2025-10-21 |
| Est. Completion | 2029-06-01 |
| Phase | Phase 1 |
What NCT06995872 shows while recruiting
NCT06995872 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 4 interventions - of which Temozolomide is the first listed.
NCT06995872 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06995872 about?
NCT06995872 is a clinical study titled "Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma". 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. E...
What is the current status of trial NCT06995872?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2025-10-21. Estimated completion is 2029-06-01.
What conditions does trial NCT06995872 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT06995872?
The interventions under investigation include: Temozolomide (DRUG), Irinotecan Hydrochloride (DRUG), rhIL-15 (DRUG), Dinituximab (DRUG).
Who is sponsoring clinical trial NCT06995872?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06995872 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Neuroblastoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06995872's enrollment target sits among peer trials
34 56th of 94 higher than 38 of 94 other Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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