Multicenter Observer-Blind Randomized Phase II Parallel Study Comparing Three Doses of Subcutaneous Interleukin 2 After Megatherapy and Peripheral Stem Cell Reinfusion in Stage 4 Neuroblastoma in Patients Over 1 Year of Age

OBJECTIVES: I. Determine the maximum dose that can be administered in an ambulatory setting among three dose regimens in children with stage IV neuroblastoma. II. Determine the highest tolerated level if a sustained increase in NK-cell number is observed. III. Determine the type, duration, and reversibility of side effects at the three dose levels. IV. Confirm the chosen dose level.

OUTLINE: This is a randomized, parallel, open label, multicenter study. Part I: Patients receive one of three doses of interleukin-2 (IL-2) subcutaneously beginning 20 to 40 days following autologous stem cell reinfusion. IL-2 is administered for 5 consecutive days every 14 days for up to 3 months, for a total of 6 courses. Cohorts of 5 patients are entered at each dose level of IL-2 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 3 or more patients experience dose limiting toxicity. Part II: Additional patients receive IL-2 at the dose level below the MTD. These patients are stratified according to prior therapy (melphalan plus megatherapy vs total body irradiation or meta-iodobenzylguanidine scan plus melphalan vs busulfan containing regimens). Patients are followed at 1 week.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.