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Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

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ClinicalTrials.gov Identifier: NCT02885649
Recruitment Status : Terminated (Funding unavailable)
First Posted : August 31, 2016
Last Update Posted : February 16, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eric A. Singer, MD, MA, MS, FACS, Rutgers Cancer Institute of New Jersey

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.

Condition or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Stage I Renal Cell Cancer Drug: Enzalutamide Other: Laboratory Biomarker Analysis Procedure: Nephrectomy Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)
Actual Study Start Date : December 5, 2017
Actual Primary Completion Date : March 2, 2020
Actual Study Completion Date : March 2, 2020


Arm Intervention/treatment
Experimental: Treatment (enzalutamide, nephrectomy)
Patients receive enzalutamide PO daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.
Drug: Enzalutamide
Given PO
Other Names:
  • ASP9785
  • MDV3100
  • Xtandi

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Nephrectomy
Undergo partial or radical nephrectomy




Primary Outcome Measures :
  1. Cell proliferation [ Time Frame: Up to 36 months ]
  2. Tumor apoptosis as measured by annexin [ Time Frame: Up to 36 months ]

Secondary Outcome Measures :
  1. Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4 [ Time Frame: Up to 36 months ]
    Post-operative complications will be documented according to the Clavien-Dindo Classification System.

  2. Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 36 months ]

Other Outcome Measures:
  1. AR expression measured in pre- and post-treatment tissue samples by immunohistochemistry (IHC) [ Time Frame: Up to 36 months ]
    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.

  2. Genome-wide analysis of post-treatment tissue samples assessed by whole exome and RNA sequencing [ Time Frame: Up to 36 months ]
  3. Intracrine androgen signaling levels of testosterone and dihydrotestosterone assessed in tissue [ Time Frame: Up to 36 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02885649


Locations
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United States, New Jersey
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
Rutgers, The State University of New Jersey
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Eric Singer Rutgers Cancer Institute of New Jersey
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Responsible Party: Eric A. Singer, MD, MA, MS, FACS, Principal Investigator, Rutgers Cancer Institute of New Jersey
ClinicalTrials.gov Identifier: NCT02885649    
Other Study ID Numbers: 081604
NCI-2016-01113 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
081604 ( Other Identifier: Rutgers Cancer Institute of New Jersey )
P30CA072720 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2016    Key Record Dates
Last Update Posted: February 16, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases