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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
2.5 mg by mouth daily
600 mg by mouth daily
OHSU Knight Cancer Institute
Portland, Oregon, United States
Progression-free Survival at 3 Months
Time frame: 3 months post 1st dose
Overall Number of Participants Who Achieve a Response Rate (Complete Response, Partial Response, and Stable Disease) at 3 Months
Time frame: Up to 4 years
Median Time to Progression
Time frame: Time to progression
Number of Subjects That Demonstrated a Reduction in Tumor Measurements.
Number of subjects that received at least one post-baseline scan that demonstrated a reduction in sum target lesions per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Time frame: Up to 4 years
Number of Participants With Adverse Events
Toxicity assessments will be obtained as follows: Cycle 1: Weeks 1,2,3 Cycle 2: Weeks 6,9 Cycle 3: Weeks 12, 15 Cycle 4: Weeks 18, 21 Cycle 5: Weeks 24, 27 Cycle 6+: Every visit during these cycles Safety assessments will consist of evaluating adverse events and serious adverse events.
Time frame: Duration of study, Up to 4 years
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