Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)

Conditions
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Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer

Intervention / Treatment
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* Drug: Enzalutamide
* Other: Laboratory Biomarker Analysis
* Procedure: Nephrectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical T1N0M0 (=< 7 cm) renal mass as measured on cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI]) Biopsy proven ccRCC Tumor with androgen receptor (AR) expressed >= 4580 copies/ug ribonucleic acid (RNA) Can provide informed consent Adequate hepatic function (>= 1.5 x upper limit of normal [ULN]; patient's with Gilbert's disease are not excluded) Adequate renal function (estimated glomerular filtration rate [GFR] > 40mL/min) No evidence of metastatic disease on baseline imaging (chest x-ray [CXR] or chest CT, abdominal CT or MRI) Eastern Cooperative Oncology Group (ECOG) performance status =< 2 Exclusion Criteria: Prior use of androgen deprivation including enzalutamide Pregnant women or women who are of child bearing age who are not willing to use two (2) forms of contraception during treatment with enzalutamide and for six (6) months after treatment Men must use adequate methods of contraception during and at least 3 months after treatment if engaging in sexual activity with a female of child bearing age Known hypersensitivity to enzalutamide History of unprovoked deep vein thrombosis/pulmonary embolism (DVT/PE) in past twelve (12) months Inability to stop anticoagulants/antiplatelet therapy peri-operatively History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma) History of loss of consciousness or transient ischemic attack within twelve (12) months of enrollment Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within twelve (12) months prior to screening Known or suspected brain metastasis or active leptomeningeal disease Current use of exogenous testosterone Retroperitoneal/hilar adenopathy concerning for locally advanced disease Metastatic RCC

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment (enzalutamide, nephrectomy)<br>Patients receive enzalutamide PO daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy. | Drug: Enzalutamide<br>* Given PO<br>* Other names: Xtandi;Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Procedure: Nephrectomy<br>* Undergo partial or radical nephrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell proliferation |  | Up to 36 months | 
| Tumor apoptosis as measured by annexin |  | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 36 months | 
| Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 |  | Up to 36 months |