Abstract
BACKGROUND: We assessed the safety and efficacy of ifosfamide and vinorelbine (IV) as a less toxic and effective reinduction regimen for pediatric patients with relapsed or refractory Hodgkin Lymphoma. PROCEDURE: This multi-center Children's Oncology Group phase II pilot study enrolled patients <30 years of age with biopsy-proven Hodgkin Lymphoma in relapse or refractory disease after front-line therapy. Treatment consisted of ifosfamide 3,000 mg/m(2) intravenous infusion over 24 hr on Days 1-4 and vinorelbine 25 mg/m(2) /dose intravenous push on Days 1 and 5 of each 21 day cycle with cytokine support. The study endpoints included estimation of key toxicities (cardiac, hepatic, or renal toxicity or toxic death), the rate of successful peripheral stem cell harvesting, and response after two cycles of therapy. RESULTS: Sixty-six patients received a median of two cycles of IV. Sixty-four of 66 were heavily pretreated, 4 had refractory disease, 55% were male and 79% had nodular sclerosis HL. The primary toxicities were hematologic. Harvested peripheral stem cells were sufficient for autologous transplantation in 46 of 54 patients for whom stem cell collection was attempted. The overall response rate (72%; 95% CI 59-83%) permitted the majority of patients to undergo subsequent stem cell transplantation. CONCLUSIONS: IV is a safe and effective re-induction regimen for salvage of pediatric patients with relapsed or refractory Hodgkin Lymphoma with an excellent response rate and success of post chemotherapy stem cell harvest. It avoids the use of etoposide, an agent associated with secondary malignancy after stem cell transplantation.