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Objetivo: Conduzimos estudo de fase I/II para avaliar atividade antitumoral do alcool perilico (AP) por via inalatoria em pacientes com gliomas recidivantes. Pacientes e Metodos: Trinta e sete pacientes com glioma recidivante apos tratamento convencional foram matriculados, dos quais 29 com glioblastoma (GBM), 5 com astrocitoma anaplasico (AA) e 3 com oligodendroglioma anaplasico (OA). O objetivo foi determinar a sobrevida livre de progressao no 6o mes e a toxicidade do AP administrado 4 vezes ao dia em pacientes refratarios ao tratamento convencional. Resultados: Os resultados mostraram no 6o mes de tratamento, resposta parcial em 1 paciente (3,4%) com GBM e 1 paciente (33,3%) com OA; doenca estavel em 13 pacientes (44,8%) com GBM, 3 pacientes (60%) com AA e 1 paciente (33,3%) com OA; progressao da doenca em 15 pacientes (51,7%) com GBM, 2 pacientes (40%) com AA e 1 paciente (33,3%) com OA. A sobrevida livre de progressao (somatorio de resposta parcial e doenca estavel) foi de 48,2% para pacientes com GBM, 60% para pacientes com AA e 66,6% para pacientes com OA. Conclusao: O presente trabalho mostrou pela primeira vez, que a administracao intranasal de um inibidor da transducao do sinal, alcool perilico, e uma estrategia segura, nao invasiva, de baixo custo, e a regressao do volume tumoral em alguns pacientes e sugestivo de atividade antitumoral. (AU) Objective: A phase I/II study to evaluate the antitumoral activity of perillyl alcohol (POH) intranasal delivery in patients with recurrent gliomas was conducted. Patients and Methods: Thirty-seven patients with recurrent gliomas after standard therapy were enrolled, of whom 29 presented with glioblastoma (GBM), 5 with anaplastic astrocytoma (AA), and 3 with anaplastic oligodendroglioma (AO). The objective was to determine progression-free survival at 6 months and the safety for POH in a 4 x daily schedule in patients who failed conventional treatment. Results: After 6 months of treatment the fol¬lowing was observed: Partial Response: 3.4% (n=1) with GBM and 33,3% (n=1) with AO; Stable Disease: 44.8% (n=13) with GBM, 60% (n=3) with AA and 33.3% (n=1) with AO; Progressive Course: 51.7% (n= 15) with GBM, 40% (n=2) with AA and 33.3% (n=1) AO. The progression free survival (sum of partial responses and stable disease) was 48.2% for patients with GBM, 60%, for AA patients and 66.6% for AO patients. Conclusion: The present work indicates, for the first time, that intranasal administration of the signal transduction inhibitor, perillyl alcohol, is a safe, non- invasive, low cost treatment and that regres¬sion of tumor size in some patients is suggestive of antitumoral activity.(AU)

Estudo exploratório da administração intranasal do monoterpeno álcool perílico em pacientes com glioma recidivante