Use of Racotumomab in Patients With Pediatric Tumors Expressing N-glycolylated Gangliosides

Launched by LABORATORIO ELEA PHOENIX S.A. · May 11, 2012

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Children (both genders) of between 1 and 10 years old at the time of accrual.
• • Diagnosis of neuroblastoma (progression after first line treatment), glioma (progressing disease or metastatic disease, without curative treatment options), Ewing's sarcoma (progressive metastatic disease to first line treatment or progressive disease to second line treatment), Wilm's tumor (metastatic relapse after treatment), or retinoblastoma (progressing disease or metastatic relapse during or after first line treatment).
• • Previous cancer treatment finished 30 days before accrual.
• • Lansky performance status over 50.
• Exclusion Criteria:
• • History of encephalopathy, convulsions, asthma or severe allergy.
• • Infectious disease grade 3 or 4 according to CTCAE version 3.
• • Hepatic, kidney or cardiac insufficiency.
• • Marrow insufficiency after self-transplantation of hematopoietic stem cells.
• • Weight inferior to 12 kg at the time of accrual.
• • Concomitant cancer treatment.
• • Inability to comply with study procedures.