Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). 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.
Primary Outcome
Designed to collect comprehensive safety/toxicity data, as well as additional efficacy data for the immunotherapy. To address the primary objective, descriptive analyses summarizing the number and type of AEs will be performed. The percentage of patients reporting each unacceptable (Grade 3 or higher) CTC toxicity code, tabulated by course, are reported.
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 |
What the finished NCT01041638 record still lists
NCT01041638 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which Diagnostic Laboratory Biomarker Analysis is the first listed.
NCT01041638 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01041638's enrollment target sits among peer trials
105 1670th of 2000 higher than 330 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03372317 · 105 participants
Tau PET in Imaging and Cognition: Healthy Adults From 55-90
- NCT04253964 · 105 participants · Phase 2
Pilot Study of Performance Status 2 vs. Performance Status 0-1 Non-small Cell Lung Cancer Patients Treated With Chemo/Immunotherapy
- NCT04742452 · 105 participants · NA
Comparison of Partial Rotator Cuff Repair vs. Superior Capsular Reconstruction for Irreparable Rotator Cuff Tears
- NCT04875429 · 105 participants · NA
Zenith® Fenestrated+ Clinical Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI