ANBL0032, PHASE III RANDOMIZED STUDY OF CHIMERIC ANTI-GD2 IN HIGH RISK NEUROBLAE

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Neuroblastoma is the third most common malignancy of childhood.1-2 More than one half of patients have high-risk tumors and have dismal outcome despite aggressive therapy (3 year event-free survival less than 15%).3-4 A somewhat improved outcome has been obtained with autologous bone marrow transplantation after intensive chemotherapy.5-7 However, more than one half of these patients will still relapse and succumb to the tumor. This is especially true for those patients who were diagnosed to have stage IV neuroblastoma after 1 year of age. The major obstacle to curing these patients derives from refractory microscopic disease. A promising approach is immunotherapy targeting a tumor associated antigen, GD2, which has been shown to be uniformly expressed by neuroblastoma, some melanomas, brain tumors, small cell carcinomas of the lung, 12 and some sarcomas.13 In normal human tissues, GD2 expression is restricted in neuroblastoma and restricted distribution in normal tissues makes anti-GD2 monoclonal antibodies (mabs) suitable for tumor targeted immunotherapy. Clinical trials with anti-tumor mabs suggest that mabs specific for GD2 may be useful in passive immunotherapy of cancer. The primary purpose is to determine if the monoclonal antibody Ch14.18 + cytokines +13-cis-retinoic acid (RA) improves event free survival and overall survival after myeloablative therapy and stem cell rescue as compared to RA alone, in high risk neuroblastoma patients who have achieved a pre-ASCT response.