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

Cedars-Sinai Medical Center

Status: Completed

Conditions: Cancer

Treatments: Other: Matched targeted drug treatment; Other: Unmatched standard of care

Study type: Observational

Funder types: Other

Identifiers

NCT03098576

IIT2015-20-Mita-CSMCMatch

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

52 participants in 2 patient groups

Matched

Description:

Matched targeted drug treatment

Treatment:

Other: Matched targeted drug treatment

Control

Description:

Unmatched standard of care

Treatment:

Other: Unmatched standard of care