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.
Allocation: Randomized, Primary Purpose: Treatment
Ruth Ladenstein, MD
St. Anna Kinderkrebsforschung
United States: Federal Government