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Biological Therapy in Treating Patients With Neuroblastoma That Has Not Responded to Previous Treatment
This study is currently recruiting patients.
Sponsored by: | Memorial Sloan-Kettering Cancer Center |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Monoclonal antibodies such as 3F8 can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Beta-glucan, isotretinoin, and sargramostim may increase the effectiveness of monoclonal antibody 3F8 by making tumor cells more sensitive to the monoclonal antibody. Combining different types of biological therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining beta-glucan, isotretinoin, and sargramostim with monoclonal antibody 3F8 in treating patients who have neuroblastoma that has not responded to previous treatment.
Condition | Treatment or Intervention | Phase |
---|---|---|
localized unresectable neuroblastoma disseminated neuroblastoma regional neuroblastoma stage 4S neuroblastoma recurrent neuroblastoma |
Drug: beta-glucan Drug: isotretinoin Drug: monoclonal antibody 3F8 Drug: sargramostim Procedure: antibody therapy Procedure: biological response modifier therapy Procedure: colony-stimulating factor therapy Procedure: cytokine therapy Procedure: differentiation therapy Procedure: monoclonal antibody therapy Procedure: non-specific immune-modulator therapy |
Phase II |
MedlinePlus related topics: Neuroblastoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Monoclonal Antibody 3F8, Beta-Glucan, Isotretinoin and Sargramostim (GM-CSF) in Patients With High-Risk Refractory Neuroblastoma
OBJECTIVES:
OUTLINE: This is an open-label study. Patients are stratified according to refractory disease (primary refractory [never had disease progression or disease recurrence] vs secondary refractory [recurrent disease that did not respond completely to reinduction therapy]).
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 27-74 patients (10-33 for stratum 1 and 17-41 for stratum 2) will be accrued for this study.
Eligibility
Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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