Genomic Profiling in Recommending Treatment for Patients With Metastatic Solid Tumors


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Trial ID: NCT02215928,


This research trial studies using genomic profiling to recommend anticancer treatment to patients with cancer that has spread beyond the original site of the tumor (metastatic cancer). Genomic profiling studies the deoxyribonucleic acid (DNA) of a tumor to detect genetic changes or abnormalities. This information can then be used to recommend treatments that may be more likely to result in a beneficial response. It is not yet known whether genomic profiling will detect abnormalities that can be used to make treatment recommendations and whether treatment based on genomic profiling is more effective than standard treatment.

Official Title

Tumor Genomic Profiling: A Personalized Medicine Approach

Stanford Investigator(s)

James Ford
James Ford

Professor of Medicine (Oncology) and of Genetics and, by courtesy, of Pediatrics


Inclusion Criteria:

   - Understand and provide written informed consent and Health Insurance Portability and
   Accountability Act (HIPAA) authorization prior to initiation of any study-specific

   - Have a diagnosis of metastatic, incurable cancer and have progressed on at least one
   line of systemic therapy OR a cancer with no standard 1st-line systemic therapy shown
   to prolong survival (or where a clinical trial recommended as the 1st-line option)

   - Measurable disease (RECIST 1.1)

   - Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

   - In the opinion of the investigator, be medically suitable for and willing to undergo a
   biopsy or surgical procedure to obtain tissue as a part of routine care for their
   malignancy OR have adequate archival tissue from a previous biopsy available for

   - Female patients of childbearing potential must have a negative pregnancy test and
   agree to use at least one form of contraception during the study and for at least one
   month after treatment discontinuation; for the purposes of this study, child-bearing
   potential is defined as: all female patients that were not in post-menopause for at
   least one year or are surgically sterile

   - Male patients must use a form of barrier contraception approved by the
   investigator/treating physician during the study and for at least one month after
   treatment discontinuation

Exclusion Criteria:

   - Have lesions that are not accessible to biopsy or not planned for biopsy as part of
   routine care OR if archival tissue will be used for profiling, an insufficient amount
   is available

   - Have diagnosis of a hematologic malignancy

   - Have symptomatic central nervous system (CNS) metastasis; patients with a history of
   CNS metastases who have been treated with whole brain irradiation must be stable
   without symptoms for 4 weeks after completion of treatment, with image documentation
   required, and must be either off steroids or on a stable dose of steroids for >= 2
   weeks prior to enrollment

   - Have uncontrolled concurrent illness including, but not limited to, ongoing or active
   serious infection, symptomatic congestive heart failure, unstable angina pectoris,
   unstable cardiac arrhythmias, psychiatric illness, or situations that would limit
   compliance with the study requirements or the ability to willingly give written
   informed consent

   - Have known human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C
   virus (HCV) infection

   - Are pregnant or breast-feeding patients or any patient with childbearing potential not
   using adequate contraception


genetic: mutation analysis

other: cytology specimen collection procedure

other: laboratory biomarker analysis


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Meredith Mills

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