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Type(s) of Cancer
Neuroblastoma
Study Phase
Phase 3
Study Completion Date
2013-12-10
NCT00033293Uploaded 09-30-2020
Access via NCI by Request
PDS UID: nci-data-429
A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone
Provider Information
Provider Data DescriptionThere are three datasets: NCT00033293-D1 NCT00033293-D2 and NCT00033293-D3 for PMID 29376112. USI is the patient identifier in all datasets. NCT00033293-D1 There is one row for each patient enrolled on ANBL00P3. The dataset provides the information necessary to reproduce patient baseline characteristics, evaluability, treatment received, disease response, and survival.
SponsorChildren's Oncology Group
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophosphamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma. Drugs used in chemotherapy, work in different ways to stop tumor cells from dividing so they stop growing or die. Steroid therapy decreases inflammation. Combining chemotherapy and steroid therapy with immunoglobulin may be effective in treating abnormal muscle movement associated with neuroblastoma.
ConditionsLocalized Resectable Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Stage 4 Neuroblastoma
Stage 4S Neuroblastoma
Intervention TypeOther: Clinical Observation
Drug: Cyclophosphamide
Other: Laboratory Biomarker Analysis
Procedure: Magnetic Resonance Imaging
Drug: Prednisone
Biological: Therapeutic Immune Globulin
Drug(s)Drug: Cyclophosphamide
Drug: Prednisone
Total Enrolled53
RandomizationRandomized
Blinding MethodNone
Arms InterventionArm I (chemotherapy, immunoglobulin therapy) - Experimental
Arm II (chemotherapy, observation) - Active Comparator
Secondary IDNCI-2009-00399
PubMed (PMID)29376112
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Australia
Canada
Age Range8 Years and younger (CHILD)
Files: NCT00033293-D1
Data DictionaryNCT00033293-D1-Data-Dictionary_1.pdf
DATANCT00033293-D1-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00033293-D2
Data DictionaryNCT00033293-D2-Data-Dictionary_1.pdf
DATANCT00033293-D2-Dataset_1.csv
OTHERREADME.pdf
Files: NCT00033293-D3
Data DictionaryNCT00033293-D3-Data-Dictionary_1.pdf
DATANCT00033293-D3-Dataset_1.csv
OTHERREADME.pdf
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