Extrait

To find an improved treatment schedule which reduces the pain-toxicity profile of ch14.18/CHO whilst maintaining immunomodulatory efficacy in patients (1-21 years old) with primary refractory (≥ 2 lines of conventional treatment) or relapsed neuroblastoma through prolonged continuous infusion in combination with s.c aldesleukin (IL-2). V3: Based on the IL-2 toxicity profile and recent data from the HRNBL1 SIOPEN trial, the study committee decided to evaluate the role of IL-2 for EFS (event free survival) in the LTI setting by randomizing the current standard arm against an ch14.18/CHO only treatment arm (additional randomised question = ARAQ). The use of isotretinoin remains unchanged in both treatment arms

Critère d'inclusion

• High-risk neuroblastoma patients having received at least one previous high dose treatment followed by stem cell rescue after conventional therapy fulfilling one of the following criteria: • Primary refractory patients with stage 4 disease with at least two lines of treatment prior to HDT/SCT, causing a delay from diagnosis to SCT of over 9 months • Relapse after primary stage 4 disease • Disseminated relapse after primary localized neuroblastoma

Liens

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