This pilot early phase I trial studies how well enzalutamide works before surgery in treating patients with kidney cancer. Androgens are a type of hormone produced by the body that may cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the amount of androgens produced by the body and keep kidney tumors from growing.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02885649.
PRIMARY OBJECTIVES:
I. To investigate the effects of neoadjuvant enzalutamide on renal cell carcinoma (RCC).
II. To determine if treatment with enzalutamide induces apoptosis in RCC expressing androgen receptor (AR).
SECONDARY OBJECTIVES:
I. To examine the reduction in tumor size by Response Evaluation Criteria in Solid Tumors (RECIST) after neoadjuvant treatment with enzalutamide.
II. To evaluate peri-operative safety.
LABORATORY OBJECTIVES:
I. To assess AR expression.
II. To assess intracrine androgen signaling.
III. To assess the treatment effect of enzalutamide on RCC by genome-wide analysis study using whole exome and ribonucleic acid (RNA) sequencing.
OUTLINE:
Patients receive enzalutamide orally (PO) daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.
After completion of study treatment, patients are followed up at 1-2 weeks and then at 3-6 months.
Lead OrganizationRutgers Cancer Institute of New Jersey
Principal InvestigatorSaum B Ghodoussipour
