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Brief Title: Use of Racotumomab in Patients With Pediatric Tumors Expressing N-glycolylated Gangliosides
Official Title: 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.
Study ID: NCT01598454
Brief Summary: This study will be carried out in children with diagnosis of cancer with tumors known to express N-glycolylated gangliosides. The disease must be resistant to conventional therapy. The acute toxicity and immune response will be evaluated. The expression of N-glycolylated gangliosides in tumors has previously been investigated in the tumor sample bank at this Hospital. The expression of N-glycolyl GM3 was shown in neuroblastoma, Ewing's sarcoma, Wilm's tumor and retinoblastoma. Gliomas and the aforementioned tumor types have a very bad prognosis when conventional treatment is ineffective. New therapeutic strategies have thus been examined, and several immunotherapeutic approaches, including dendritic cell vaccines, peptide vaccines and anti-idiotype vaccines are currently being assessed. Racotumomab is an anti-idiotype antibody capable of inducing anti-N-glycolyl GM3 antibodies in patients with melanoma, breast cancer and lung cancer. Dose escalation studies have shown the safety of racotumomab in the 0.5 to 2 mg dose range. The 1 mg dose level was selected for the ensuing clinical studies. This clinical trial in children involves three dose levels: 0.15 mg, 0.25 mg and 0.4 mg, owing to the difference in body surface between an adult (1.73 sq. m in average) and the candidate population for this study (0.55 to 0.7 sq. m).
Detailed Description:
Minimum Age: 1 Year
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Prof. Dr. J. P. Garrahan National Children's Hospital, Buenos Aires, , Argentina
Name: Walter Cacciavillano, MD
Affiliation: Prof. Dr. J. P. Garrahan National Children's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Guillermo Chantada, MD
Affiliation: Prof. Dr. J. P. Garrahan National Children's Hospital
Role: STUDY_DIRECTOR