interleukin-2 in treating children with stage iv neuroblastoma who have received induction therapy and peripheral stem cell transplantation

Conditions: Neuroblastoma

Summary: rationale: interleukin-2 may stimulate a person's white blood cells to kill neuroblastoma cells. purpose: phase ii trial to study the effectiveness of interleukin-2 in treating children with stage iv neuroblastoma who have received induction therapy and peripheral stem cell transplantation.

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.

Eligibility criteria:
disease characteristics: histologically proven stage iv neuroblastoma at least stable disease after modern induction regimens and megatherapy followed by autologous stem cell reinfusion patient characteristics: age: over 1 performance status: lansky 80-100% life expectancy: not specified hematopoietic: lymphocyte count at least 500/mm3 platelet count at least 30,000/mm3 hemoglobin at least 8 g/dl (at least 1 week since transfusional support) blood coagulation less than 25% above upper limit of normal (uln) for age (who grade 0) hepatic: bilirubin less than 25% above uln for age (who grade 0) renal: creatinine less than 25% above uln for age (who grade 0) cardiovascular: no significant history or current evidence of cardiovascular disease (e.g., uncontrolled hypertension, serious arrhythmias) normal shortening fraction at cardiac ultrasonography normal ecg other: no evidence of active infections normal chest x-ray normal brain ct scan no other concurrent disease or second primary malignancy prior concurrent therapy: biologic therapy: see disease characteristics no other concurrent immunotherapy chemotherapy: see disease characteristics no concurrent chemotherapy endocrine therapy: no concurrent corticosteroids or other hormonal therapy radiotherapy: no concurrent radiotherapy surgery: not specified other: at least 30 days since prior investigational drugs or devices no concurrent investigational drugs, agents, or devices

Keywords: disseminated neuroblastoma