Neuroblastoma Clinical Trial
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.
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).
n/a
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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