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

Completed

• Conditions: Cancer
• Interventions: Other: Unmatched standard of care; Other: Matched targeted drug treatment

• Registration Number: NCT03098576
• Lead Sponsor: Cedars-Sinai Medical Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-03-28
• Study First Submitted: 2017-03-28
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Status Verified: 2024-03
• Primary Completion: 2024-03-01
• Study Completion: 2024-03-01
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Unmatched standard of care	Unmatched standard of care
Matched	Matched targeted drug treatment	Matched targeted drug treatment

Primary Outcome Measures

Name	Time	Method
Response rate	3 years	To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States