Main
|
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: |
|
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
|
|