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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03098576
• Other study ID #: IIT2015-20-Mita-CSMCMatch
• Status: Completed
• Start date: March 28, 2017
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Matched targeted drug treatment
Matching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug.
• Unmatched standard of care
All patients with either no identified mutation or no available matching treatment but undergoing a systemic treatment will be enrolled in the "control group."

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers.	3 years
Secondary	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
Secondary	Overall survival	Evaluate time until death.	3 years