Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

Rutgers The State University of New Jersey

Status and phase: Terminated; Early Phase 1

Conditions: Stage I Renal Cell Cancer; Clear Cell Renal Cell Carcinoma

Treatments: Other: Laboratory Biomarker Analysis; Procedure: Nephrectomy; Drug: Enzalutamide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02885649

P30CA072720 (U.S. NIH Grant/Contract)

NCI-2016-01113 (Registry Identifier)

Pro20170000806

081604 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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
• Current use of exogenous testosterone
• Retroperitoneal/hilar adenopathy concerning for locally advanced disease
• Metastatic RCC

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Treatment (enzalutamide, nephrectomy)

Experimental group

Description:

Patients receive enzalutamide PO daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.

Treatment:

Drug: Enzalutamide

Other: Laboratory Biomarker Analysis

Procedure: Nephrectomy