Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

Clear Cell Renal Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02885649
• Other study ID #: Pro20170000806
• Secondary ID: NCI-2016-0111308
• Status: Terminated
• Phase: Early Phase 1
• Start date: December 5, 2017
• Est. completion date: March 2, 2020

Study information

• Verified date: September 2021
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2, 2020
• Est. primary completion date: March 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Clear Cell Renal Cell Carcinoma
• Stage I Renal Cell Cancer

Intervention

Drug:
• Enzalutamide
Given PO

Other:
• Laboratory Biomarker Analysis
Correlative studies

Procedure:
• Nephrectomy
Undergo partial or radical nephrectomy

Locations

Country	Name	City	State
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AR expression measured in pre- and post-treatment tissue samples by immunohistochemistry (IHC)	Pre- and post-treatment ccRCC samples will be used to purify mRNA, construct cDNA, and perform qPCR to quantify expression of mRNA. IHC staining will be performed on ccRCC pre- and post-treatment.	Up to 36 months
Other	Genome-wide analysis of post-treatment tissue samples assessed by whole exome and RNA sequencing		Up to 36 months
Other	Intracrine androgen signaling levels of testosterone and dihydrotestosterone assessed in tissue	Pre- and post-treatment tissue levels of testosterone and dihydrotestosterone will be compared to their respective serum levels to assess intracrine androgen signaling in ccRCC following enzalutamide treatment.	Up to 36 months
Primary	Cell proliferation		Up to 36 months
Primary	Tumor apoptosis as measured by annexin		Up to 36 months
Secondary	Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4	Post-operative complications will be documented according to the Clavien-Dindo Classification System.	Up to 36 months
Secondary	Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1		Up to 36 months