This randomized pilot clinical trial studies the side effects of tremelimumab with or without tissue cryoablation in treating patients with kidney cancer that has spread to other places in the body. Tremelimumab binds to a protein called cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), which is found on the surface of T cells (a type of white blood cell). Tremelimumab may block CTLA-4 and help the immune system kill cancer cells. Cryoablation is a procedure that uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. It is not yet known whether tremelimumab with or without cryoablation is effective in treating patients with kidney cancer.
Name: Cryosurgery
Description: Undergo cryoablationType: ProcedureArm B (tremelimumab and cryoablation)
Name: Laboratory Biomarker Analysis
Description: Correlative studiesType: OtherArm A (tremelimumab) Arm B (tremelimumab and cryoablation)
Name: Therapeutic Conventional Surgery
Description: Undergo surgeryType: ProcedureArm A (tremelimumab) Arm B (tremelimumab and cryoablation)
Name: Tremelimumab
Description: Given IVType: BiologicalArm A (tremelimumab) Arm B (tremelimumab and cryoablation)
Description: Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm. Descriptive statistical analyses will be performed to summarize the incidence of adverse events.
Measure: Incidence of adverse events as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 Time: Up to 2 weeksDescription: Extreme toxicities will be defined as any grade 3 or higher adverse event that is possibly, probably, or definitely related to therapy that occurs within the first two cycles of therapy with the following exceptions: any grade 3 or higher adverse event that is potentially treatable with steroids will only count as an extreme toxicity if it does not improve to grade 1 or better within 2 weeks of steroid therapy, grade 3 or 4 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations of pancreatitis, or grade 3 or 4 drug related endocrinopathies which within two weeks of presentation are adequately controlled with only physiologic hormone replacement therapy.
Measure: Incidence of extreme toxicities as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 Time: Up to 2 weeksDescription: Descriptive statistical analyses will be performed to summarize the response rate including summary tables, scatter-plots, box-plots, proportions, 95% credible intervals, median, means, and standard deviations.
Measure: Response rate Time: Up to 5 yearsDescription: Differences of indication markers between arms will be compared using a t-test with transformations of non-normal data, as needed. A mixed model accounting for patient effects will be used to analyze the longitudinal data on immunological values over time.
Measure: Changes in indication markers Time: Up to 5 yearsDescription: Descriptive statistical analyses will be performed.
Measure: Progression free survival Time: Up to 5 yearsDescription: A mixed model accounting for patient effects will be used to analyze the longitudinal data on immunological values over time.
Measure: Longitudinal data on immunological values over time Time: Up to 13 weeksAllocation: Randomized
Parallel Assignment
There is one SNP
After surgery or biopsy, patients receive tremelimumab IV every 4 weeks (Q4W) for 3 doses, and then every 12 weeks (Q12W) in the absence of disease progression or unacceptable toxicity. --- Q12W ---
After surgery or biopsy, patients receive tremelimumab IV Q4W for 3 doses, and then Q12W in the absence of disease progression or unacceptable toxicity. --- Q12W ---