Sorafenib Tosylate and Stereotactic Radiosurgery in Treating Patients With Brain Metastases
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|ClinicalTrials.gov Identifier: NCT01276210|
Recruitment Status : Completed
First Posted : January 13, 2011
Last Update Posted : July 17, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Tumors Metastatic to Brain||Drug: sorafenib tosylate Radiation: stereotactic radiosurgery Other: laboratory biomarker analysis||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Trial of Sorafenib and Stereotactic Radiosurgery for Patients With 1-4 Brain Metastases|
|Study Start Date :||February 2011|
|Primary Completion Date :||July 2015|
|Study Completion Date :||June 2017|
See Detailed Description
Drug: sorafenib tosylate
Other Names:Radiation: stereotactic radiosurgery
Undergo stereotactic radiosurgeryOther: laboratory biomarker analysis
- The maximum tolerated dose (MTD) of combining sorafenib with SRS [ Time Frame: At 1 month ]
- Intra-cranial progression-free survival (PFS) [ Time Frame: At 6 months ]
- Overall survival(OS) in study patient population [ Time Frame: at 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276210
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Anuradha Chakravarthy||Vanderbilt-Ingram Cancer Center|