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Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

Primary Purpose

Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Enzalutamide

Laboratory Biomarker Analysis

Nephrectomy

About this trial

This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (enzalutamide, nephrectomy)

Arm 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.

Outcomes

Primary Outcome Measures

Cell proliferation

Tumor apoptosis as measured by annexin

Secondary Outcome Measures

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.

Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Full Information

NCT ID

NCT02885649

First Posted

August 26, 2016

Last Updated

September 14, 2021

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02885649

Brief Title

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

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Terminated

Why Stopped

Funding unavailable

Study Start Date

December 5, 2017 (Actual)

Primary Completion Date

March 2, 2020 (Actual)

Study Completion Date

March 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (enzalutamide, nephrectomy)

Arm Type

Experimental

Arm 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.

Intervention Type

Drug

Intervention Name(s)

Enzalutamide

Other Intervention Name(s)

ASP9785, MDV3100, Xtandi

Intervention Description

Given PO

Intervention Type

Other

Intervention Name(s)

Laboratory Biomarker Analysis

Intervention Description

Correlative studies

Intervention Type

Procedure

Intervention Name(s)

Nephrectomy

Intervention Description

Undergo partial or radical nephrectomy

Primary Outcome Measure Information:

Title

Cell proliferation

Time Frame

Up to 36 months

Title

Tumor apoptosis as measured by annexin

Time Frame

Up to 36 months

Secondary Outcome Measure Information:

Title

Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4

Description

Post-operative complications will be documented according to the Clavien-Dindo Classification System.

Time Frame

Up to 36 months

Title

Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time Frame

Up to 36 months

Other Pre-specified Outcome Measures:

Title

AR expression measured in pre- and post-treatment tissue samples by immunohistochemistry (IHC)

Description

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.

Time Frame

Up to 36 months

Title

Genome-wide analysis of post-treatment tissue samples assessed by whole exome and RNA sequencing

Time Frame

Up to 36 months

Title

Intracrine androgen signaling levels of testosterone and dihydrotestosterone assessed in tissue

Description

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.

Time Frame

Up to 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric Singer

Organizational Affiliation

Rutgers Cancer Institute of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rutgers Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

12. IPD Sharing Statement

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Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

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