Phase I Studies of TarcevaTM (Erlotinib Hydrochloride, OSI-774) as Single Agent in Children With Refractory and Relapsed Malignant Brain Tumors and in Combination With Irradiation in Newly Diagnosed Brain Stem Glioma
Prognosis in relapsing malignant brain tumors is poor. Those in brain stem gliomas is
dismal; median survival of these children does not exceed 9 months. Radiation therapy may
result in early and transient amelioration of symptoms, but have not contributed to increase
or prolong survival. Moreover, chemotherapy has not increased this outcome to date.Prados
et al. reported encouraging results from a phase I study of TarcevaTM/OSI-774 alone or with
temozolomide (TMZ) in patients with malignant gliomas. Of 25 evaluated patients, 6
experienced PR: 4 GBM (glioblastoma multiforme) and 1 grade 3 astrocytoma treated with
TarcevaTM alone, 1 GBM treated with TarcevaTM/TMZ; 2 had minor responses, and 3 stable
diseases. These results in malignant glioma and the lack of efficacy in brain stem glioma
with current treatment suggests the evaluation of this new therapeutic agent in children
with relapsed brain tumors and upfront at diagnosis in brain stem glioma in combination with
radiation therapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To establish the recommended dose / Maximum Tolerated Dose (MTD) the for phase II study for single agent and in combination with radiation therapy
End of recruitment
Yes
Vassal Gilles, Pr.
Study Chair
Gustave Roussy, Cancer Campus, Grand Paris
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
CSET 1120
NCT00418327
June 2005
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