Tumors Metastatic to Brain Clinical Trial
Official title:
A Phase I Trial of Sorafenib and Stereotactic Radiosurgery for Patients With 1-4 Brain Metastases
RATIONALE: Sorafenib tosylate may stop the growth of tumor cells by blocking some of the
enzymes needed for cell growth or by blocking blood flow to the tumor. Stereotactic
radiosurgery (SRS) may be able to send x-rays directly to the tumor and cause less damage to
normal tissue. Giving sorafenib tosylate together with SRS may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and the best dose of sorafenib
tosylate when given together with SRS in treating patients with brain metastases
PRIMARY OBJECTIVES:
I. To determine the safety, tolerability and maximum tolerated dose (MTD) of sorafenib, when
administered in combination with SRS to patients with 1-4 metastatic brain tumors.
SECONDARY OBJECTIVES:
I. To assess the six-month intra-cranial progression-free survival (PFS) of sorafenib when
administered in combination with SRS to patients with 1-4 metastatic brain tumors. PFS is
defined as the time to intra-cranial tumor progression or death.
II. To assess the six-month overall survival (OS) of sorafenib when administered in
combination with SRS to patients with 1-4 metastatic brain tumors.
III. To compare results to patients who are treated with SRS alone (concurrent controls).
OUTLINE: This is a dose-escalation study of sorafenib tosylate.
Patients receive oral (PO) sorafenib tosylate once daily and undergo SRS 5-7 days later.
Treatment with sorafenib continues for 2 weeks after SRS in the absence of disease
progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 8, 26, and 52 weeks.
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