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| Descriptive Information Fields | |||||
| Brief Title † | Cyclophosphamide and Prednisone With or Without Immunoglobulin in Treating Abnormal Muscle Movement in Children With Neuroblastoma | ||||
| Official Title † | A Phase III Randomized Trial of Intravenous Gammaglobulin Therapy for Patients With Neuroblastoma Associated Opsoclonus-Myoclonus-Ataxia Syndrome Treated With Chemotherapy and Prednisone | ||||
| Brief Summary | RATIONALE: 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. PURPOSE: This randomized phase II trial is studying cyclophosphamide, prednisone, and immunoglobulin to see how well they work compared to cyclophsophamide and prednisone alone in treating patients with abnormal trunk muscle movements associated with neuroblastoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk group per protocol COG-ANBL00B1 (low risk vs intermediate risk on COG-A3961 vs high risk on COG-A3973).
Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive prednisone twice daily for 3 months and then every other day for 7-15 months.
Patients are followed during therapy every month for 6 months, at 1 year, and then annually thereafter. PROJECTED ACCRUAL: A total of 18-52 patients (9-26 per treatment arm) will be accrued for this study within 2-5.8 years. |
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| Study Phase | Phase III | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Active Control | ||||
| Primary Outcome Measure † | Efficacy as measured by assessment of response of opsoclonus, gait, neural, stance, arm and hand function at baseline, 2 months, 6 months, and 1 year [ Designated as safety issue: No ] Response as measured by assessment of opsoclonus, gait, neural, stance, arm and hand function at baseline, 2 months, 6 months, and 1 year [ Designated as safety issue: No ] |
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| Secondary Outcome Measure † | Motor coordination as assessed by neurological examination and Vineland Adaptive Behavior Scale at baseline, 1 and 5 years [ Designated as safety issue: No ] Functional outcome as assessed by age-appropriate neuropsychological testing at baseline, 1 and 5 years [ Designated as safety issue: No ] Biology of neuroblastoma associated opsoclonus-myoclonus-ataxia syndrome, specifically by MRI findings, anti-neuronal antibodies, SCF findings and tumor biology at baseline, 6 months, and 1 year [ Designated as safety issue: No ] Long-term prognosis for neurologic recovery by neurological examination at baseline, 1 and 5 years [ Designated as safety issue: No ] Tumor outcome in terms of event-free survival and overall survival at 1, 5, and 10 years [ Designated as safety issue: No ] |
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| Condition † | Neuroblastoma | ||||
| Intervention † | Drug: therapeutic immune globulin Procedure: observation |
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| MEDLINE PMIDs | |||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 52 | ||||
| Start Date † | March 2004 | ||||
| Completion Date | |||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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| Gender | Both | ||||
| Ages | up to 8 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Australia, Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00033293 | ||||
| Organization ID | CDR0000069271 | ||||
| Secondary IDs †† | COG-ANBL00P3 | ||||
| Study Sponsor † | Children's Oncology Group | ||||
| Collaborators †† | National Cancer Institute (NCI) | ||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | November 2008 | ||||
| First Received Date † | April 9, 2002 | ||||
| Last Updated Date | November 21, 2008 | ||||