NCT01276210

Sorafenib Tosylate and Stereotactic Radiosurgery in Treating Patients With Brain Metastases

A Phase I Trial of Sorafenib and Stereotactic Radiosurgery for Patients With 1-4 Brain Metastases

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Tumors Metastatic to Brain

Interventions

Type	Name	Description
DRUG	sorafenib tosylate	Given PO
RADIATION	stereotactic radiosurgery	Undergo stereotactic radiosurgery
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2011-02-01
• Primary completion: 2015-07-01
• Completion: 2017-06-01
• First posted: 2011-01-13
• Last updated: 2017-07-17

Locations

1 site across 1 country: United States