Cancer
Conditions
Keywords
advanced, metastatic solid tumors
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.
Interventions
OTHERMatched targeted drug treatment
Matching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug.
OTHERUnmatched 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.
Sponsors
Cedars-Sinai Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate | 3 years | To evaluate the proportion of patients with response to targeted study agent(s) in patients with advanced cancers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Overall survival | 3 years | Evaluate time until death. |
Countries
United States
Outcome results
None listed