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Neuroblastoma

A Pilot Study Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone

Unique Dataset IDnci-data-429ClinicalTrial.gov IDNCT00033293
DownloadableNo
SponsorChildren's Oncology GroupData ProviderNational Cancer InstituteTotal Study Enrolled Patients53RandomizationYesPubMed (PMID)29376112.0
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataN/AIntervention TypeN/ADataset TypeOther

Clinical Trial Title

A Pilot Study Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone

Trial Summary and Conditions

This 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 eye and trunk muscle movements (known as opsoclonus myoclonus ataxia) 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. Chemotherapy(cyclophosphamide), prednisone and intravenous gamma globulin all suppress the immune system which may be helpful in treating opsoclonus-myoclonus-ataxia (OMA).

Data Summary

See Data Dictionary.

Study Objectives

Primary: Determine if immunosuppressive therapy with cyclophosphamide and prednisone is an effective therapy for neuroblastoma associated opsoclonus-myoclonus-ataxia (OMA) and can constitute a back-bone therapy upon which to build additional therapy; Determine in a randomized study if the addition of intravenous gammaglobulin therapy to the back-bone therapy of prednisone and cyclophosphamide improves response of neuroblastoma associated OMA. Secondary: Determine if intravenous gammaglobulin therapy improves the motor coordination of children diagnosed with neuroblastoma and presenting with OMA syndrome as assessed by neurological examination and the Vineland Adaptive Behavior Scale (VABS); Determine if these regimens improve functional outcome in these patients. III. Investigate the biology of neuroblastoma associated OMA, with specific regard to magnetic resonance imaging (MRI) findings, anti-neuronal antibodies, cerebrospinal fluid (CSF) findings and tumor biology; Define better the long-term prognosis for neurologic recovery in the child with neuroblastoma associated with OMA syndrome; Define the event-free and overall survival of patients with neuroblastoma associated opsoclonus-myoclonus-ataxia syndrome

Outcome Measures

Primary:Number of Responders [Time Frame: Changes from baseline to 2 months, 6 months, and 1 year]. Secondary: Motor Coordination as Assessed by Neurological Examination and Vineland Adaptive Behavior Scale (VABS) [Time Frame: Changes from baseline to the better of 6 months or 1 year]; Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing [Time Frame: Changes from baseline to the better of 6 months or 1 year]; Biology of Neuroblastoma Associated Opsoclonus-myoclonus-ataxia (OMA) Syndrome Specifically by MRI Findings, Anti-neuronal Antibodies, Cerebrospinal Fluid (CSF) Findings and Tumor Biology [Time Frame: At diagnosis, 6 months, 1 year, 5 and 10 years after diagnosis]; Long-term Prognosis for Neurologic Recovery by Neurological Examination; Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death; Tumor Outcome in Terms of Overall Survival (OS) Rate

ClinicalTrial.gov

Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):

NCI Description

There 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.

Available Downloads: NCT00033293-D1

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00033293-D1-Data-Dictionary_1.pdf

DATA: NCT00033293-D1-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT00033293-D2

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00033293-D2-Data-Dictionary_1.pdf

DATA: NCT00033293-D2-Dataset_1.csv

OTHER: README.pdf

Available Downloads: NCT00033293-D3

To gain access to the data and analytic tools click here.

Data Dictionary: NCT00033293-D3-Data-Dictionary_1.pdf

DATA: NCT00033293-D3-Dataset_1.csv

OTHER: README.pdf