This pilot phase 0 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.
PRIMARY OBJECTIVES: I. To investigate the effects of neoadjuvant enzalutamide on clear cell renal cell carcinoma (ccRCC). OUTLINE: Patients receive enzalutamide orally (PO) daily for 90 days 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 every 3 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Given PO
Correlative studies
Undergo partial or radical nephrectomy
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Cell proliferation
Time frame: Up to 36 months
Tumor apoptosis as measured by annexin
Time frame: Up to 36 months
Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4
Post-operative complications will be documented according to the Clavien-Dindo Classification System.
Time frame: Up to 36 months
Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.