Patients with metastatic renal cell cancer will be enrolled to receive RAD001 to determine whether the use of RAD001 will result in an improvement in the time to tumor progression.
Patients with metastatic renal cell cancer will be enrolled in the study if all eligibility criteria are met and they agree to participate. The participant will take RAD001 (Everolimus) 10mg by mouth once a day. During the first cycle, they will have blood work done once a week (4 weeks). On cycles thereafter they will have blood work on days 7 and 21. Once a month, the patient will have a chest x-ray. Every 8 weeks the patient will have a CT scan of the chest, abdomen and pelvis. If clinically indicated, additional tests will be done.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
Participant will take RAD001 (Everolimus) 10mg by mouth once a day.
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States
To collect data on time to tumor progression produced by the study treatment.
Time frame: restaging every 8 weeks
Response rate
Time frame: restaging every 8 weeks
Duration of tumor response
Time frame: restaging every 8 weeks
Safety and toxicity
Time frame: AEs as occur
Six month and 12 month survival rate
Time frame: at 6 months and at 12 months
Overall survival
Time frame: restaging every 8 weeks
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