This trial is completed!
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You can access this
clinical trial
if you have
Neuroblastoma, Ewing's Sarcoma, Wilm's Tumor, Retinoblastoma or Glioma
and you are
between 1 and 10
years old
Phase
1
This is an early phase trial to determine
the dosage and safety of the new treatment.
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The purpose

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).

Provided treatments

  • Drug: racotumomab
Tris trial is registered with FDA with number: NCT01598454. The sponsor of the trial is Laboratorio Elea S.A.C.I.F. y A. and it is looking for 15 volunteers for the current phase.
Official trial 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.