Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Study Overview
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Brief Summary
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The purpose of this study is to examine the usefulness of matching patients to targeted therapy by analyzing a tumor sample taken at diagnosis and testing it against 50 cancer-associated genes. Targeted therapy is a highly personalized, newer approach to cancer treatment that aims to more precisely identify and attack cancer cells, in an effort to do less damage to normal cells.

Detailed Description
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Targeted therapy in this study can be either off label-use of a U.S. Food and Drug Administration (FDA) approved drug or a clinical trial that includes investigational drugs. Matched targeted therapy outcomes will be compared to the outcomes of patients who were not matched to a treatment. In order to find a matched treatment, a patient's sample will undergo a test known as a gene chip algorithm. This is will be done by having a sample of a patient's tumor analyzed at a Cedars-Sinai Medical Center (CSMC) laboratory that specializes in molecular profiling. Molecular profiling is a process used to study a tumor's genetic characteristics. DNA will be taken from the tumor sample and will be screened for actionable genes. These genes are called actionable because mutations (structural changes) in these genes have FDA-approved matched therapies or are eligible for current clinical studies.

Official Title
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Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Conditions
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Cancer

Intervention / Treatment
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* Other: Matched targeted drug treatment
* Other: Unmatched standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced and metastatic solid tumors who have failed standard treatments known to improve survival Female and male adults age 18 and older. ECOG PS 0-2 Acceptable hematological, renal, or liver function Patients planning to undergo a systemic treatment Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: Significant comorbidities that could interfere with the study (compliance and visits)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Matched<br>Matched targeted drug treatment | Other: Matched targeted drug treatment<br>* Matching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug.<br>|
| Control<br>Unmatched standard of care | Other: Unmatched standard of care<br>* All patients with either no identified mutation or no available matching treatment but undergoing a systemic treatment will be enrolled in the control group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate | To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival | To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced cancers. | 6 months | 
| Overall survival | Evaluate time until death. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced, metastatic solid tumors