Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Glioma

Astrocytoma

Oligodendroglioma

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Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Oligoastrocytoma

Anaplastic Oligoastrocytoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Sorafenib dose escalation scheme: 3 first patients: 200 mg/d, if dose limiting toxicities (DLT) not reached: 3 patients at 200 mg BID, if no DLT reached: 3 patients at 400 mg bid

Sorafenib dose escalation

Pierre-Yves Dietrich, MD

This is a phase I study to evaluate the safety and tolerability of Sorafenib in combination with Temodar and radiation therapy in patients with newly diagnosed high grade glioma (glioblastoma, gliosarcoma, anaplastic astrocytoma and anaplastic oligodendroglioma or oligoastrocytoma). The mechanism of action of sorafenib, an oral multikinase inhibitor, makes it an interesting drug to investigate in the treatment of patients with high grade glioma as this agent has anti-angiogenic activity and inhibits other pathways such as Ras, Platelet-derived growth factor (PDGF) and fms-like tyrosine kinase receptor-3 (Flt-3), which are potential targets against gliomas.

Up to 18 patients will be included in this phase I study. The primary goal of this study will be to establish the maximum tolerated dose of sorafenib when used in combination with temozolomide and radiation therapy. Secondary goals of this study include: response rate, time to treatment failure, 6 month progression-free survival, event free survival and overall survival. A correlative study will investigate the pharmacokinetics of sorafenib used in combination with radiation therapy and temozolomide.

Sorafenib in Newly Diagnosed High Grade Glioma

Phase I Dose Finding Study of Sorafenib in Combination With Radiation Therapy and Temozolomide as a First Line Treatment of Patients With High Grade Glioma

Safety and tolerability of sorafenib in combination with radiation and temozolomide chemotherapy in patients with newly diagnosed high grade glioma

Bayer

University Hospital, Geneva

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sorafenib in Newly Diagnosed High Grade Glioma	NCT00884416	Glioblastoma Gliosarcoma Anaplastic Astr... Anaplastic Olig... Anaplastic Olig...	Sorafenib dose ...	18 Years -	University Hospital, Geneva
Sorafenib in Newly Diagnosed High Grade Glioma	NCT00884416	Glioblastoma Gliosarcoma Anaplastic Astr... Anaplastic Olig... Anaplastic Olig...	Sorafenib dose ...	18 Years -	University Hospital, Geneva

Spots Global Cancer Trial Database for sorafenib dose escalation