Phase 1 Study on the Use of Racotumomab Anti-idiotype Antibody in Patients With Pediatric Malignancies That Express N-glycolylated Gangliosides and Are Resistant to Conventional Treatment.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Selection of the higher safe dose level for ensuing clinical trials
One of the three dose levels assessed in this study will be selected for further clinical testing in children: 0.15 mg, 0,25 mg or 0.4 mg.
Up to 1 year
Yes
Walter Cacciavillano, MD
Principal Investigator
Prof. Dr. J. P. Garrahan National Children's Hospital
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
AR-RACO-1-2-09
NCT01598454
February 2011
September 2013
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