Personalized Targeted Inhibitors Treatment in Renal Cell Cancer

Carcinoma, Renal Cell Clinical Trial

Official title: Targeting of Renal Cell Cancer With Specific Inhibitors: A Model for Selective Adaptive Medicine Based on Molecular Alterations

Status Terminated

Clinical Trial Summary

This is for subjects with metastatic Renal Cell Cancer (RCC). There are four Food and Drug Administration (FDA) approved drugs for first-line therapy of Renal Cell Cancer (RCC) and two for second-line therapy. Each of these drugs targets a specific molecular pathway. At present oncologists select therapy based on current guidelines. There is a new method for trying to use biomarker information from the subject's tumor to select the best drug to treat the subject. This process is investigational, which is why this study is being done.

Biomarkers are genes, proteins and other molecules that affect how cancer cells grow, multiply, die and respond to other compounds in the body. These biomarkers build a tumor profile or "fingerprint" of the subject's tumor. A new focus in cancer care is personalized treatment, where doctors select a drug based on the subject's tumor's unique "fingerprint" which is more likely to be effective in fighting the tumor. Selecting the treatment the subject is more likely to respond to requires a thorough understanding of the relationship between biomarker and treatment effect. The PI wants to gather data to understand that relationship to help treat future cancer patients. The purpose of this study is to evaluate efficacy of treatments that are selected based on tumor profiles.

Clinical Trial Description

This will be a prospective, one-arm, proof of concept study designed to evaluate the efficacy of algorithm-based allocation (based on genomic/proteomic profile) of first-line therapy in renal cell carcinoma (RCC).

After eligibility review, patients will receive one of the four first-line therapy agents based on their tumor's molecular profile as determined using fresh biopsy tissue from an accessible metastatic site. Upon disease progression, patients will then receive one of two second-line agents based on their tumor's molecular profile.

Because this is a proof-of-concept study, the sample size is based on feasibility of accrual. The clinic should be able to recruit 100 patients within a reasonable timeframe for the study. The number of patients receiving each drug will vary based on the frequency of molecular alterations in the population. Therefore, groups will not be compared with one another - the research goal is to determine whether the progression-free survival (PFS) for each drug is improved over the PFS reported in FDA approval trials for each drug when they are assigned based on molecular analysis. ;

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

• NCT number: NCT02560012
• Study type: Interventional
• Source: The University of Texas Health Science Center, Houston
• Status: Terminated
• Phase: Phase 2
• Start date: January 4, 2016
• Completion date: July 27, 2017