Enzalutamide Before Surgery in Treating Patients With Kidney Cancer

NCT02885649 | Terminated Early Phase 1 DMC FDA Drug

• 4 other identifiers: Pro20170000806NCI-2016-01113081604P30CA072720
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Clear Cell Renal Cell Carcinoma; Stage I Renal Cell Cancer

Outcome Measures

Primary Outcomes (2)

• Cell proliferation

  Up to 36 months

• Tumor apoptosis as measured by annexin

  Up to 36 months

Secondary Outcomes (2)

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

  Up to 36 months

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

  Up to 36 months

Other Outcomes (3)

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

  Up to 36 months

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

  Up to 36 months

• Intracrine androgen signaling levels of testosterone and dihydrotestosterone assessed in tissue

  Up to 36 months

Study Arms (1)

Treatment (enzalutamide, nephrectomy)

EXPERIMENTAL

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; Other: Laboratory Biomarker Analysis; Procedure: Nephrectomy

Interventions

Enzalutamide DRUG

Given PO

Also known as: ASP9785, MDV3100, Xtandi

Treatment (enzalutamide, nephrectomy)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (enzalutamide, nephrectomy)

Nephrectomy PROCEDURE

Undergo partial or radical nephrectomy

Treatment (enzalutamide, nephrectomy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

enzalutamide; Nephrectomy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Eric Singer

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: December 5, 2017
• Primary Completion: March 2, 2020
• Study Completion: March 2, 2020
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

US (1)