Kidney Cancer Clinical Trial
Official title:
A Phase II Study of the Mammalian Target of Rapamycin (mTOR) Inhibitor RAD001 in Combination With Imatinib Mesylate in Patients With Previously Treated Advanced Renal Carcinoma
RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking
some of the enzymes needed for cell growth. Everolimus may also block blood flow to the
tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib
mesylate works in treating patients with metastatic or unresectable kidney cancer.
OBJECTIVES:
Primary
- Estimate the proportion of patients with previously treated metastatic or unresectable
clear cell carcinoma of the kidney who are progression free (complete response [CR],
partial response [PR], or stable disease [SD]) at 3 months after treatment with
everolimus and imatinib mesylate.
Secondary
- Estimate median time to progression in patients treated with this regimen.
- Determine the proportion of patients whose best overall response are CR, PR, SD, or
progressive disease.
- Evaluate the mean and range of the maximum percent reduction in tumor size.
- Describe the toxicities of this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1 and
continuing in the absence of disease progression.
PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
;
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