Clinical trial NCT02885649: Enzalutamide Before Surgery in Treating Patients With Kidney Cancer
Official title: Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Clear Cell Renal Cell Carcinoma
Stage I Renal Cell Cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-08-31
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Cell proliferation
timeFrame: Up to 36 months
measure: Tumor apoptosis as measured by annexin
timeFrame: Up to 36 months
Secondary outcomes:
measure: Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4
timeFrame: Up to 36 months
measure: Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
timeFrame: Up to 36 months
Other outcomes:
measure: AR expression measured in pre- and post-treatment tissue samples by immunohistochemistry (IHC)
timeFrame: Up to 36 months
measure: Genome-wide analysis of post-treatment tissue samples assessed by whole exome and RNA sequencing
timeFrame: Up to 36 months
measure: Intracrine androgen signaling levels of testosterone and dihydrotestosterone assessed in tissue
timeFrame: Up to 36 months
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Eric Singer
role: PRINCIPAL_INVESTIGATOR
References: