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Type(s) of Cancer
Neuroblastoma
Study Phase
Phase 3
Study Completion Date
December 2013
NCT01041638Uploaded 09-23-2020
Access via NCI by Request
PDS UID: nci-data-426
A Comprehensive Safety Trial of Chimeric Antibody 14.18 (Ch14.18) With GM-CSF, IL-2 and Isotretinoin in High-Risk Neuroblastoma Patients Following Myeloablative Therapy
Provider Information
Provider Data DescriptionThe data and analysis for the results reported in Table 6 in the paper published was completed externally. Given the limited access to the original data, Table 6 subsequently has not been able to be replicated. There is one row for each patient enrolled on ANBL0931. The dataset provides the information necessary to reproduce patient baseline characteristics, disease outcome, and survival for patients on ANBL0931.
SponsorNational Cancer Institute (NCI)
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis 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.
ConditionsHigh Risk Neuroblastoma
Intervention TypeBiological: Aldesleukin
Other: Diagnostic Laboratory Biomarker Analysis
Biological: Dinutuximab
Drug: Isotretinoin
Biological: Sargramostim
Drug(s)Drug: Isotretinoin
Total Enrolled105
RandomizationN/A
Blinding MethodNone (Open Label)
Arms InterventionTreatment (Ch14.18, GM-CSF, IL-2, isotretinoin) - Experimental
Secondary IDNCI-2011-01997
PubMed (PMID)N/A
Collaborator(s)N/A
Region(s)United States
Age RangeN/A (Child, Adult, Older Adult)
Files: NCT01041638-D1
Data DictionaryNCT01041638-D1-Data-Dictionary_5.pdf
DATANCT01041638-D1-Dataset.CSV
OTHERREADME.pdf
Files: NCT01041638-D2
Data DictionaryNCT01041638-D2-Data-Dictionary_3.pdf
DATANCT01041638-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01041638-D3
Data DictionaryNCT01041638-D3-Data-Dictionary_3.pdf
DATANCT01041638-D3-Dataset_1.csv
OTHERREADME.pdf
Files: NCT01041638-D4
Data DictionaryNCT01041638-D4-Data-Dictionary_3.pdf
DATANCT01041638-D4-Dataset_4.csv
OTHERREADME.pdf
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