Trial Information

Perinatal Neuroblastoma: Expectant Observation A Children's Oncology Group Pilot Study

PRIMARY OBJECTIVE:

I. Determine whether nonoperative management of infants with adrenal masses found on
prenatal and/or neonatal imaging results in a 3-year survival rate of 95%.

SECONDARY OBJECTIVES:

I. Estimate the percentage of these patients who are spared surgical resection. II. Evaluate
the natural history and histology of perinatal adrenal masses. III. Evaluate the tumor
biology and histology of prenatal and neonatal neuroblastomas.

IV. Determine the tumor characteristics that are associated with a need for resection.

OUTLINE:

Patients undergo an abdominal CT or MRI scan on weeks 0, 6, and 42 and an abdominal sonogram
on weeks 0, 3, 6, 12, 18, 30, 42, 66, and 90. Urinary catecholamine levels are also measured
on the same weeks as the abdominal sonogram. Patients with an increase in tumor volume or
catecholamine levels undergo sonographic evaluation and urine catecholamine sampling every 3
weeks until stabilization. Patients with a continued increase in catecholamine levels or a
50% increase in tumor volume undergo surgical resection off study.

Patients are followed within 1 week and then every 6 months for 3 years.