Conditions: Kidney Cancer
Keywords: stage III renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 23
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth

Interventions: intervention 1: Everolimus intervention 2: imatinib mesylate
Intervention descriptions: intervention 1: 2.5 mg by mouth daily intervention 2: 600 mg by mouth daily

Protocol document: