Phase I Study of the Combination of Sorafenib and Radiation Therapy -/+ Temozolomide for the Treatment of Patients With Brain Metastases and Primary Brain Tumors
The current standard of care for patients with brain metastatic malignancies is to receive
radiation therapy alone, while the standard of care for patients with high grade primary
brain malignancies, astrocytomas, is to receive to receive concurrent temozolomide with
radiation therapy. In this phase I study, based on the range of efficacy of kinase
inhibitors and its ability to cross the blood-brain barrier we will conduct two parallel
studies. The first is to combine sorafenib and radiation therapy for the treatment of
patients with brain metastases and the second is to combine sorafenib with temozolomide for
primary brain tumors.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose of Sorafenib
To determine the maximum tolerated dose (MTD) and a recommended phase II dose (RP2D) of Sorafenib and radiotherapy -/+ temozolomide patients with malignancies of the brain.
30 days post-treatment
Yes
Adam Dicker, MD, PhD
Principal Investigator
Thomas Jefferson University
United States: Institutional Review Board
07P.381
NCT00639262
March 2008
March 2013
Name | Location |
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Thomas Jefferson University | Philadelphia, Pennsylvania 19107-6541 |