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

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

Condition: Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer

Intervention:

  • Drug: Enzalutamide
  • Other: Laboratory Biomarker Analysis
  • Procedure: Nephrectomy

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02885649

Sponsor: Rutgers, The State University of New Jersey

Primary Outcome Measures:

  • Measure: Cell proliferation
  • Time Frame: Up to 36 months
  • Safety Issue:
  • Measure: Tumor apoptosis as measured by annexin
  • Time Frame: Up to 36 months
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4
  • Time Frame: Up to 36 months
  • Safety Issue:
  • Measure: Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Time Frame: Up to 36 months
  • Safety Issue:

Estimated Enrollment: 20

Study Start Date: December 5, 2017

Phase: Early Phase 1

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

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

Location:

  • Rutgers Cancer Institute of New Jersey
  • New Brunswick New Jersey 08903 United States

View trial on ClinicalTrials.gov

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