Spots Global Cancer Trial Database for Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway

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Trial Identification

Brief Title: Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Patients With Medulloblastomas With an Activation of the Sonic Hedgehog Pathway

Official Title: An International, Randomized, Open-label Phase I/II Study of Vismodegib in Combination With Temozolomide Versus Temozolomide Alone in Adult Patients With Recurrent or Refractory Medulloblastomas Presenting an Activation of the Sonic Hedgehog (SHH) Pathway

Study ID: NCT01601184

Conditions

Histologically Confirmed Medulloblastoma

Activation of the Sonic Hedgehog (SHH) Pathway

Interventions

vismodegib

Temozolomide

Study Description

Brief Summary: The purpose of this study is to evaluate the safety of vismodegib in combination with temozolomide (primary objective - phase I) and to estimate the efficacy of vismodegib in combination with temozolomide in adult patients with recurrent, progressive, or refractory medulloblastomas to standard therapy measured by the 6-month progression-free rate (phase II). This study is an open-label Phase I/II, international, randomized. 38 patients will be included in the study.

Detailed Description: Secondary objectives are : phase I : to collect preliminary results on the 6-month progression-free rate of the combination vismodegib + temozolomide PHASE II To estimate in the two study arms: * the objective response rate (Complete response + Partial Response according to WHO criteria) after 6 months of treatment * the duration of treatment response * the best overall response obtained during the study * the progression-free survival (PFS) * the time to progression (TTP) * the time to treatment failure (TTF) * In the combination arm (vismodegib + temozolomide): to further evaluate the safety of the combination.