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Enzalutamide before Surgery in Treating Patients with Kidney Cancer, the BARE Study

Trial Status: Active

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.

Inclusion Criteria

  • Clinical T1N0M0 (=< 7 cm) renal mass as measured on cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
  • Biopsy proven RCC
  • Tumor with AR expressed >= 4580 copies/ug RNA
  • Can provide informed consent
  • Adequate hepatic function (aspartate aminotransferase [AST]/alanine aminotransferase [ALT] >= 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] > 40 mL/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
  • Ability to undergo MRI of abdomen or contrast-enhanced CT abdomen If MRI contraindicated)

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
  • Inability to take enzalutamide because of drug-drug interaction
  • 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
  • Component of sarcomatoid RCC
  • Investigator discretion regarding any factor that could increase risk to subject

New Jersey

New Brunswick
Rutgers Cancer Institute of New Jersey
Status: ACTIVE
Contact: Eric Alan Singer
Phone: 732-235-3272

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.

Trial Phase Phase O

Trial Type Treatment

Lead Organization
Rutgers Cancer Institute of New Jersey

Principal Investigator
Eric Alan Singer

  • Primary ID 081604
  • Secondary IDs NCI-2016-01113, Pro20170000806
  • Clinicaltrials.gov ID NCT02885649