Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
Overview
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining colony-stimulating factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for advanced neuroblastoma. PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus sargramostim in treating patients who have advanced neuroblastoma.
Full Title of Study: “PHASE II TRIAL OF MONOCLONAL ANTIBODY 3F8 AND GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR (GM-CSF) FOR NEUROBLASTOMA”
Study Type
- Study Type: Interventional
- Study Design
- Primary Purpose: Treatment
- Study Primary Completion Date: April 2005
Detailed Description
OBJECTIVES: – Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in patients with advanced neuroblastoma. – Assess the biological effects of 3F8/GM-CSF in these patients. OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable toxicity. PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.
Interventions
- Biological: monoclonal antibody 3F8
- Biological: sargramostim
Participating in This Clinical Trial
DISEASE CHARACTERISTICS:
- Neuroblastoma diagnosed by INSS criteria, i.e., either: – Histologic proof of disease OR – Tumor clumps in bone marrow plus elevated catecholamine levels – Relapsed disease with poor long-term prognosis as indicated by at least one of the following: – N-myc amplification in tumor cells – Diploid chromosomal content in tumor cells – Distant skeletal metastases – Unresectable primary tumor crossing the midline – Bone marrow with greater than 10% tumor cells – Documentation of measurable progressive disease or biopsy- proven stable disease at least 4 weeks after prior systemic therapy required – No rapidly progressive disease – Poor risk neuroblastoma (but without measurable disease) not eligible for other neuroblastoma protocols PATIENT CHARACTERISTICS: Age: – 2 to 21 Performance status: – Not specified Life expectancy: – Greater than 8 weeks Hematologic: – Not specified Hepatic: – No grade 3/4 toxicity – LDH no greater than 1.5 times upper limit of normal Renal: – Creatinine clearance at least 60 mL/min – No grade 3/4 toxicity Cardiovascular: – No grade 3/4 toxicity Pulmonary: – No grade 3/4 toxicity Other: – No grade 3/4 neurologic, gastrointestinal, or other organ toxicity except grade 3 hearing deficit – No active life threatening infections – No human antimouse antibody (HAMA) greater than 1,000 ELISA units/mL – No allergy to mouse proteins – No pain requiring opiates PRIOR CONCURRENT THERAPY: Biologic therapy – Not specified Chemotherapy – Standard chemotherapy to which disease is resistant or myeloablative therapy followed by disease recurrence required Endocrine therapy – Not specified Radiotherapy – Not specified Surgery – Not specified
Gender Eligibility: All
Minimum Age: 2 Years
Maximum Age: 21 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Overall Official(s)
- Brian H. Kushner, MD, Study Chair, Memorial Sloan Kettering Cancer Center
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