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NCT01041638 · ClinicalTrials.gov registry record · Phase 3
Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous 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
- 105
- Enrollment target
NCT01041638: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT01041638 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 105 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01041638, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
Study Summary
This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill them. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood. Aldesleukin may stimulate the white blood cells to kill tumor cells. Isotretinoin may help neuroblastoma cells become more like normal cells, and to grow and spread more slowly. Giving monoclonal antibody Ch14.18 with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant may be an effective treatment for neuroblastoma.
Interventions
- OTHER Diagnostic Laboratory Biomarker Analysis
- BIOLOGICAL Aldesleukin
- DRUG Isotretinoin
- BIOLOGICAL Sargramostim
- BIOLOGICAL Dinutuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2009-12-21 |
| Est. Completion | 2021-06-30 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01041638
The ClinicalTrials.gov registry entry for NCT01041638 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Diagnostic Laboratory Biomarker Analysis is the first listed.
NCT01041638 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01041638 about?
NCT01041638 is a clinical study titled "Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma". This phase III trial is studying the side effects of giving monoclonal antibody Ch14.18 together with sargramostim, aldesleukin, and isotretinoin after autologous stem cell transplant in treating patients with neuroblastoma. Monoclonal antibodies, such as Ch14.18, may find tumor cells and help kill ...
What is the current status of trial NCT01041638?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2009-12-21. Estimated completion is 2021-06-30.
What interventions are being tested in trial NCT01041638?
The interventions under investigation include: Diagnostic Laboratory Biomarker Analysis (OTHER), Aldesleukin (BIOLOGICAL), Isotretinoin (DRUG), Sargramostim (BIOLOGICAL), Dinutuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT01041638?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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