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NCT02298348 · ClinicalTrials.gov registry record · Phase 1
Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma
A Phase 1 study of Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 12
- Study locations
NCT02298348: Active Phase 1 study of Neuroblastoma, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
NCT02298348 is a Phase 1 study of Neuroblastoma that is active but no longer recruiting, run by New Approaches to Neuroblastoma Therapy Consortium. The registered enrollment target is 18 participants, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02298348, a Phase 1 study of Neuroblastoma, is active but no longer recruiting, sponsored by New Approaches to Neuroblastoma Therapy Consortium.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study will combine three drugs: sorafenib, cyclophosphamide and topotecan. Adding sorafenib to cyclophosphamide and topotecan may increase the effectiveness of this combination. The investigators first need to find out the highest dose of sorafenib that can be given safely together with cyclophosphamide and topotecan. This is the first study to test giving these three drugs together and will help determine the highest dose of sorafenib that can safely be given together with cyclophosphamide and topotecan to patients with resistant/relapsed neuroblastoma.
Primary Outcome
By dose level (Dose Escalation of Sorafenib Only; The entry dose of sorafenib at 125 mg/m2 /dose is equivalent to 62.5% of the single agent MTD for pediatric solid tumor patients). Two to six evaluable patients will be entered at each of the three dose levels for determination of the maximum tolerated dose. The minimum sample size required to identify the MTD is 4 patients.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Topotecan
- DRUG Sorafenib
Study Locations (12)
California
- Children's Hospital Los Angeles - Los Angeles
- UCSF Comprehensive Cancer Center - San Francisco
Colorado
- Children Hospital of Colorado - Aurora
Georgia
- Children's Healthcare of Atlanta - Atlanta
Illinois
- University of Chicago, Comer Children's Hospital - Chicago
Massachusetts
- Childrens Hospital Boston, Dana-Farber Cancer Institute. - Boston
Michigan
- C.S Mott Children's Hospital - Ann Arbor
North Carolina
- University of North Carolina - Chapel Hill
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2015-10-08 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What the registry record for NCT02298348 still lists
NCT02298348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 239-participant average among 94 other Neuroblastoma trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Neuroblastoma appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT02298348 lists 12 locations in 11 states (California, Colorado, Georgia).
Frequently Asked Questions
What is clinical trial NCT02298348 about?
NCT02298348 is a clinical study titled "Sorafenib and Cyclophosphamide/Topotecan in Patients With Relapsed and Refractory Neuroblastoma". This study will combine three drugs: sorafenib, cyclophosphamide and topotecan. Adding sorafenib to cyclophosphamide and topotecan may increase the effectiveness of this combination. The investigators first need to find out the highest dose of sorafenib that can be given safely together with cyclop...
What is the current status of trial NCT02298348?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2015-10-08. Estimated completion is 2026-12.
What conditions does trial NCT02298348 study?
This clinical trial studies the following conditions: Neuroblastoma.
What interventions are being tested in trial NCT02298348?
The interventions under investigation include: Cyclophosphamide (DRUG), Topotecan (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT02298348?
This trial is sponsored by New Approaches to Neuroblastoma Therapy Consortium, which has 23 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02298348 being conducted?
This trial has 12 study locations across California, Colorado, Georgia, Illinois, Massachusetts. 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 NCT02298348's enrollment target sits among peer trials
18 77th of 94 higher than 14 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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Phase I Trial of rhIL-15 Plus Dinutuximab Plus Irinotecan/Temozolomide for Children and Young Adults With Relapsed/Refractory Neuroblastoma
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