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Enzalutamide Before Surgery in Treating Patients With Kidney Cancer | Clinical Trials | Clareo Health

TERMINATEDEARLY_PHASE1

Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

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

NCT02885649•Rutgers, The State University of New Jersey

Summary

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

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

Key Dates

Start Date

December 5, 2017

Primary Completion Date

March 2, 2020

Completion Date

March 2, 2020

Last Updated

September 16, 2021

Enrollment

ACTUAL participants

Conditions

Clear Cell Renal Cell CarcinomaStage I Renal Cell Cancer

Interventions

Enzalutamide

DRUG

Laboratory Biomarker Analysis

OTHER

Nephrectomy

PROCEDURE

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RECRUITINGPHASE1

Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 16, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

Inclusion Criteria

Exclusion Criteria

Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform

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