Official Title
Tumor Genomic Profiling: A Personalized Medicine Approach
Brief Title
Genomic Profiling in Recommending Treatment for Patients With Metastatic Solid Tumors
Protocol ID
NCT02215928
Lead Sponsor
Stanford University
Brief Summary
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.
Detailed Description
PRIMARY OBJECTIVES:
I. Assess the feasibility of integrating tumor genomic profiling in the adult oncology
clinic at the Stanford Cancer Institute.
SECONDARY OBJECTIVES:
I. Determine the percentage of tumors that harbor "actionable" genomic changes. II.
Explore effects of individual molecular profiling including the percent of time that
profiling changes the treatment.
III. Determine the number of cases in which a genomically identified targeted therapy is
available.
IV. Determine the clinical benefit of genomic based therapy, as defined by: response rate
(according to Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 response
criteria); the percent of patients with non-progression at 4 months, and overall
survival, in patients whose therapy is selected based on profiling.
V. Determine if circulating free tumor DNA (ctDNA) in the blood stream (liquid biopsy)
yields similar genomic results as the metastatic tumor analysis.
VI. Determine if ctDNA analysis during treatment correlates with RECIST 1.1 criteria in
predicting response.
OUTLINE:
Tissue samples are collected at baseline and blood for liquid biopsy is collected at
baseline and every 6-8 weeks during active treatment. Tissue samples are analyzed via
sequencing for tumor genomic profiling.
After completion of active treatment, participants are followed up at 4, 8, 12, 18, and
24 months.
Study Period
Enrollment Count
100 participants
Eligibility Criteria
Inclusion Criteria:
- Understand and provide written informed consent and Health Insurance Portability and
Accountability Act (HIPAA) authorization prior to initiation of any study-specific
procedures
- 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
profiling
- 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
Filters
Unspecified Adult Solid Tumor, Protocol Specific
RECRUITING
ADULT
OLDER_ADULT