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NCT00026312 · ClinicalTrials.gov registry record · Phase 3
Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,449
- Enrollment target
NCT00026312: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00026312 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1,449 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00026312, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,449 participants
- Enrollment target
Study Summary
This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as 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 block tumor growth in different ways by targeting certain cells. Aldesleukin and sargramostim may stimulate a person's white blood cells to kill cancer cells. It is not yet known if chemotherapy is more effective with or without dinutuximab, aldesleukin, and sargramostim following stem cell transplant in treating neuroblastoma.
Primary Outcome
Comparison to determine if RA + Immunotherapy improves EFS as compared to RA Only
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Aldesleukin
- DRUG Isotretinoin
- OTHER Pharmacological Study
- BIOLOGICAL Dinutuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,449 participants |
| Start Date | 2001-10-26 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 3 |
What the finished NCT00026312 record still lists
NCT00026312 is an interventional study that assigns participants to a tested intervention. Its 1,449 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00026312 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00026312 about?
NCT00026312 is a clinical study titled "Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma". This partially randomized phase III trial studies isotretinoin with dinutuximab, aldesleukin, and sargramostim to see how well it works compared to isotretinoin alone following stem cell transplant in treating patients with neuroblastoma. Drugs used in chemotherapy, such as isotretinoin, work in dif...
What is the current status of trial NCT00026312?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,449 participants. The study started on 2001-10-26. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT00026312?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Aldesleukin (BIOLOGICAL), Isotretinoin (DRUG), Pharmacological Study (OTHER), Dinutuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00026312?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00026312's enrollment target sits among peer trials
1,449 167th of 2000 higher than 1,834 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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