Spots Global Cancer Trial Database for Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain
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Trial Identification
Brief Title: Sorafenib in Treating Patients With Kidney Cancer That Has Spread to the Brain
Official Title: A Phase 2 Study of Sorafenib (BAY 43-9006) in Metastatic Renal Cell Cancer to the Brain
Study ID: NCT00301847
Interventions
Study Description
Brief Summary: This phase II trial is studying how well sorafenib works in treating patients with kidney cancer that has spread to the brain. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
Detailed Description: PRIMARY OBJECTIVES: I. Determine the partial and minor response rate in patients with renal cell carcinoma (RCC) metastatic to the brain treated with sorafenib. SECONDARY OBJECTIVES: I. Determine the toxicity of sorafenib in patients with RCC metastatic to the brain. II. Determine whether the effect of sorafenib on RCC metastatic to the brain is similar to its effect on non-brain metastatic sites. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Decatur Memorial Hospital Cancer Care Institute, Decatur, Illinois, United States
Evanston Northwestern Health Care - Evanston Hospital, Evanston, Illinois, United States
Ingalls Cancer Care Center at Ingalls Memorial Hospital, Harvey, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center, Maywood, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria, Peoria, Illinois, United States
Central Illinois Hematology Oncology Center, Springfield, Illinois, United States
Fort Wayne Medical Oncology and Hematology, Fort Wayne, Indiana, United States
CCOP - Northern Indiana CR Consortium, South Bend, Indiana, United States
Oncology Care Associates, PLLC, Saint Joseph, Michigan, United States
David C. Pratt Cancer Center at St. John's Mercy, Saint Louis, Missouri, United States
Medical College of Wisconsin Cancer Center, Milwaukee, Wisconsin, United States
Contact Details
Name: Walter M. Stadler, MD, FACP
Affiliation: University of Chicago
Role: PRINCIPAL_INVESTIGATOR
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