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 : September 16, 2021
|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|
I. To investigate the effects of neoadjuvant enzalutamide on clear cell renal cell carcinoma (ccRCC).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Other: Laboratory Biomarker Analysis
Undergo partial or radical nephrectomy
- Cell proliferation [ Time Frame: Up to 36 months ]
- Tumor apoptosis as measured by annexin [ Time Frame: Up to 36 months ]
- 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.
- Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Up to 36 months ]
- 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.
- Genome-wide analysis of post-treatment tissue samples assessed by whole exome and RNA sequencing [ Time Frame: Up to 36 months ]
- 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.
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
|United States, New Jersey|
|Rutgers Cancer Institute of New Jersey|
|New Brunswick, New Jersey, United States, 08903|
|Principal Investigator:||Eric Singer||Rutgers Cancer Institute of New Jersey|