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NCT01334515 · ClinicalTrials.gov registry record · Phase 2
Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma
A Phase 2 study, sponsored by Children's Oncology Group.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT01334515: Completed Phase 2 study, sponsored by Children's Oncology Group.
NCT01334515 is a Phase 2 study that has completed, run by Children's Oncology Group. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01334515, a Phase 2 study, has completed, sponsored by Children's Oncology Group.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ways to stimulate the immune system and stop tumor cells from growing. Drugs used in chemotherapy, such as isotretinoin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hu14.18-IL2 fusion protein together with sargramostim and isotretinoin may kill more tumor cells.
Primary Outcome
Test for tolerability and monitor for the occurrence of too many unacceptable DLTs using a two-stage stopping rule: (Stage 1) Accrue 10 patients. If more than 1 experience at least one unacceptable DLT during the first treatment cycle, the regimen will be considered to have unacceptable toxicity, and accrual will be temporarily closed, to review all relevant data and consider modifying the regimen to improve safety. If 1 or no patients have an unacceptable DLT in the first treatment cycle, then
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL sargramostim
- DRUG isotretinoin
- BIOLOGICAL hu14.18-IL2 fusion protein
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2011-09 |
| Est. Completion | 2019-09-30 |
| Phase | Phase 2 |
What the finished NCT01334515 record still lists
NCT01334515 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01334515 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01334515 about?
NCT01334515 is a clinical study titled "Biological Therapy, Sargramostim, and Isotretinoin in Treating Patients With Relapsed or Refractory Neuroblastoma". This phase II trial is studying how well hu14.18-interleukin-2 (IL2) fusion protein works when given together with sargramostim and isotretinoin in treating patients with relapsed or refractory neuroblastoma. Biological therapy, such as hu14.18-IL2 fusion protein, and sargramostim work in different ...
What is the current status of trial NCT01334515?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2011-09. Estimated completion is 2019-09-30.
What interventions are being tested in trial NCT01334515?
The interventions under investigation include: laboratory biomarker analysis (OTHER), sargramostim (BIOLOGICAL), isotretinoin (DRUG), hu14.18-IL2 fusion protein (BIOLOGICAL).
Who is sponsoring clinical trial NCT01334515?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01334515's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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