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

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ClinicalTrials.gov Identifier: NCT03098576
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Monica Mita, 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.

Condition or disease Intervention/treatment
Cancer Other: Matched targeted drug treatment Other: Unmatched standard of care

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 Type : Observational
Estimated Enrollment : 301 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Personalized Cancer Care at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
Actual Study Start Date : March 28, 2017
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 1, 2021

Group/Cohort Intervention/treatment
Matched
Matched targeted drug treatment
Other: Matched targeted drug treatment
Matching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug.

Control
Unmatched standard of care
Other: 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."




Primary Outcome Measures :
  1. Response rate [ Time Frame: 3 years ]
    To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers.


Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 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.

  2. Overall survival [ Time Frame: 3 years ]
    Evaluate time until death.


Biospecimen Retention:   Samples With DNA
Fresh or archived tissue Blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced and metastatic solid tumors who have failed standard systemic therapy.
Criteria

Inclusion Criteria:

  • Advances and metastatic solid tumors who have failed standard treatments known to improve survival
  • Female and male adults age 18 and older.
  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098576


Contacts
Contact: Bethany Wendel, RN 310-967-4339 Bethany.Wendel@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Bethany Wendel, RN    310-967-4339    Bethany.Wendel@cshs.org   
Principal Investigator: Monica Mita, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Monica Mita, MD Cedars-Sinal Medical Center

Responsible Party: Monica Mita, Associate Professor of Medicine, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT03098576     History of Changes
Other Study ID Numbers: IIT2015-20-Mita-CSMCMatch
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Monica Mita, Cedars-Sinai Medical Center:
advanced
metastatic solid tumors