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Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma

NCT01041638 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-08-17

Study results available
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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.

Conditions

  • High Risk Neuroblastoma

Interventions

BIOLOGICAL

Aldesleukin

Given IV

OTHER

Diagnostic Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Dinutuximab

Given IV

DRUG

Isotretinoin

Given PO

BIOLOGICAL

Sargramostim

Given IV or SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Mehmet F Ozkaynak · Children's Oncology Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-21
Primary Completion
2013-12-31
Completion
2021-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01041638 on ClinicalTrials.gov