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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 17 January 2022
Main ID:  NCT00033293
Date of registration: 09/04/2002
Prospective Registration: Yes
Primary sponsor: Children's Oncology Group
Public title: Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma
Scientific title: A Pilot Study Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone
Date of first enrolment: March 15, 2004
Target sample size: 53
Recruitment status: Active, not recruiting
URL:  https://clinicaltrials.gov/show/NCT00033293
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Australia Canada Netherlands New Zealand Puerto Rico Switzerland United States
Contacts
Name:     Pedro De Alarcon, MD
Address: 
Telephone:
Email:
Affiliation:  Children's Oncology Group
Key inclusion & exclusion criteria

Inclusion Criteria:

- Newly diagnosed neuroblastoma (NBL) or ganglioneuroblastoma with tumor-associated
opsoclonus-myoclonus-ataxia syndrome (OMA)

- Patients with NBL diagnosed within 6 months of OMA diagnosis AND patients with
OMA diagnosed within 6 months of NBL diagnosis are eligible

- Must enroll on study within 4 weeks of diagnosis

- Presence of opsoclonus, myoclonus, and/or ataxia associated with neuroblastoma
considered eligible

- Currently enrolled on COG neuroblastoma protocols: COG-ANBL00B1 or its successor

- No prior IV gamma globulin therapy

- No prior chemotherapy

- Concurrent chemotherapy allowed

- No prior prednisone or corticotropin

- Patients who have received = 14 days of steroids are eligible

- Concurrent surgery allowed

- Patients must be free of any organ dysfunction or disorder that the treating physician
feels may preclude the use of corticosteroid therapy (ACTH or prednisone),
cyclophosphamide therapy or intravenous gammaglobulin therapy.



Age minimum: N/A
Age maximum: 8 Years
Gender: All
Health Condition(s) or Problem(s) studied
Stage 4S Neuroblastoma
Localized Unresectable Neuroblastoma
Regional Neuroblastoma
Disseminated Neuroblastoma
Localized Resectable Neuroblastoma
Intervention(s)
Other: clinical observation
Drug: prednisone
Biological: therapeutic immune globulin
Drug: Corticotropin-Releasing Hormone
Drug: cyclophosphamide
Other: laboratory biomarker analysis
Procedure: magnetic resonance imaging
Primary Outcome(s)
Number of Responders [Time Frame: Changes from baseline to 2 months, 6 months, and 1 year]
Secondary Outcome(s)
Tumor Outcome in Terms of Overall Survival (OS) Rate [Time Frame: Up to 3 years]
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]
Functional Outcome as Assessed by Age-appropriate Neuropsychological Testing [Time Frame: Changes from baseline to the better of 6 months or 1 year]
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]
Long-term Prognosis for Neurologic Recovery by Neurological Examination [Time Frame: At diagnosis and yearly for 10 years after diagnosis]
Tumor Outcome in Terms of Event-free Survival (EFS) Rate Defined as a Relapse or Progression of Neuroblastoma, a Second Malignancy, or Death [Time Frame: Up to 3 years]
Secondary ID(s)
U10CA098543
COG-ANBL00P3
CDR0000069271
ANBL00P3
NCI-2009-00399
U10CA013539
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Cancer Institute (NCI)
Ethics review
Results
Results available: Yes
Date Posted: 03/10/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00033293
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