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NCT01711554 · ClinicalTrials.gov registry record · Phase 1
Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma
A Phase 1 study of Refractory Neuroblastoma and Recurrent Neuroblastoma, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 15
- Study locations
NCT01711554: Active Phase 1 study of Refractory Neuroblastoma and Recurrent Neuroblastoma, sponsored by National Cancer Institute (NCI).
NCT01711554 is a Phase 1 study of Refractory Neuroblastoma and Recurrent Neuroblastoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 27 participants, below the 49-participant average among 9 other Refractory Neuroblastoma trials with a reported enrollment target (45% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01711554, a Phase 1 study of Refractory Neuroblastoma and Recurrent Neuroblastoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 15
- Study locations
Study Summary
This phase I trial studies the side effects and best dose of lenalidomide when given together with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma that does not respond to treatment or that has come back. Drugs used in chemotherapy, such as lenalidomide and isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as dinutuximab, may interfere with the ability of tumor cells to grow and spread. Giving more than one drug (combination chemotherapy) together with dinutuximab therapy may kill more tumor cells.
Primary Outcome
All toxicities observed will be summarized in terms of type (organ affected or laboratory determination), severity (by NCI CTCAE), and attribution. Tables will be created to summarize these toxicities and side effects by dose level and by course as well as with Kaplan-Meier plots (i.e. time to first delay or dose reduction) in order to assess the tolerability of the regime over multiple courses.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Lenalidomide
- DRUG Isotretinoin
- OTHER Pharmacological Study
- BIOLOGICAL Dinutuximab
Study Locations (15)
California
- Children's Hospital Los Angeles - Los Angeles
- Lucile Packard Children's Hospital Stanford University - Palo Alto
- UCSF Medical Center-Parnassus - San Francisco
Massachusetts
- Boston Children's Hospital - Boston
- Dana-Farber Cancer Institute - Boston
Colorado
- Children's Hospital Colorado - Aurora
Georgia
- Children's Healthcare of Atlanta - Arthur M Blank Hospital - Atlanta
Illinois
- University of Chicago Comer Children's Hospital - Chicago
Michigan
- C S Mott Children's Hospital - Ann Arbor
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2013-02-04 |
| Est. Completion | 2027-03-03 |
| Phase | Phase 1 |
What the registry record for NCT01711554 still lists
NCT01711554 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 49-participant average among 9 other Refractory Neuroblastoma trials with a reported enrollment target (45% lower).
The record links to 2 conditions, with Refractory Neuroblastoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01711554 lists 15 locations in 12 states (California, Massachusetts, Colorado).
Frequently Asked Questions
What is clinical trial NCT01711554 about?
NCT01711554 is a clinical study titled "Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma". This phase I trial studies the side effects and best dose of lenalidomide when given together with dinutuximab with or without isotretinoin in treating younger patients with neuroblastoma that does not respond to treatment or that has come back. Drugs used in chemotherapy, such as lenalidomide and i...
What is the current status of trial NCT01711554?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2013-02-04. Estimated completion is 2027-03-03.
What conditions does trial NCT01711554 study?
This clinical trial studies the following conditions: Refractory Neuroblastoma, Recurrent Neuroblastoma.
What interventions are being tested in trial NCT01711554?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Lenalidomide (DRUG), Isotretinoin (DRUG), Pharmacological Study (OTHER), Dinutuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01711554?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01711554 being conducted?
This trial has 15 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 Refractory 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 NCT01711554's enrollment target sits among peer trials
27 8th of 9 higher than 2 of 9 other Refractory Neuroblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Refractory 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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