Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Jan 26, 2003

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• 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