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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.

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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

FieldValue
Enrollment Target 105 participants
Start Date 2009-12-21
Est. Completion 2021-06-30
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.