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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00033293 |
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.
Condition | Intervention | Phase |
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Neuroblastoma |
Drug: therapeutic immune globulin Procedure: observation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
Estimated Enrollment: | 52 |
Study Start Date: | March 2004 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I (immune globulin therapy): Experimental
Patients receive immune globulin IV on days -2 and -1, at weeks 4, 8, 12, 16, 20, and 24, and then at months 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment.
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Drug: therapeutic immune globulin
Given IV
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Arm II (immune globulin therapy): No Intervention
Patients do not receive immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I.
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Procedure: observation
Patients do not receive immune globulin.
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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.
Immune globulin therapy: Patients are randomized to 1 of 2 treatment arms.
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.
Ages Eligible for Study: | up to 8 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Newly diagnosed neuroblastoma with tumor-associated opsoclonus-myoclonus-ataxia syndrome
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study Chair: | Pedro A. de Alarcon, MD | Saint Jude Midwest Affiliate |
Study ID Numbers: | CDR0000069271, COG-ANBL00P3 |
Study First Received: | April 9, 2002 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00033293 |
Health Authority: | Unspecified |
localized resectable neuroblastoma regional neuroblastoma disseminated neuroblastoma stage 4S neuroblastoma localized unresectable neuroblastoma |
Prednisone Motor neuro-ophthalmic disorders Gamma-Globulins Neuroectodermal Tumors, Primitive Opsoclonus-Myoclonus Syndrome Cyclophosphamide Neurodegenerative Diseases Neuroblastoma Ocular motility disorders Ocular Motility Disorders Dancing eyes-dancing feet syndrome Neoplasms, Germ Cell and Embryonal Ataxia Rho(D) Immune Globulin Neuroepithelioma |
Nervous System Neoplasms Immunoglobulins Myoclonus Eye Diseases Central Nervous System Diseases Dyskinesias Neuroectodermal Tumors Antibodies Paraneoplastic Syndromes Immunoglobulins, Intravenous Neurologic Manifestations Paraneoplastic Syndromes, Nervous System Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Immunologic Factors Physiological Effects of Drugs |
Nervous System Diseases Neoplasms, Nerve Tissue Cranial Nerve Diseases Neoplasms, Neuroepithelial Pharmacologic Actions |