Clinical trial NCT02215928: Genomic Profiling in Recommending Treatment for Patients With Metastatic Solid Tumors
Official title: Tumor Genomic Profiling: A Personalized Medicine Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult oncology clinic at the Stanford Cancer Institute

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.

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

Primary outcomes:
measure: Feasibility, measured as the proportion of patients with at least one actionable alteration
timeFrame: Baseline
Secondary outcomes:
measure: Drugs (if any) that target alterations found in a patient's tumor material at baseline, as identified by the Molecular Tumor Board
timeFrame: Baseline
measure: Drugs (if any) that target alterations found in a patient's peripheral blood at baseline, as identified by the Molecular Tumor Board
timeFrame: Baseline
measure: Availability of targeted therapy from tumor material scored as category A, B, or C above or D) No target therapy available, or no genetic alterations found
timeFrame: Baseline
measure: Overall survival
timeFrame: Number of days from enrollment to death, assessed up to 24 months
measure: Clinical response rate, assessed according to RECIST 1.1 criteria
timeFrame: Up to 24 months
measure: Incidence of adverse events
timeFrame: Up to 30 days after last dose of active treatment
measure: Tumor-based genomics
timeFrame: Baseline
measure: Peripheral-blood genomics
timeFrame: Baseline
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: James MD Ford, MD
role: PRINCIPAL_INVESTIGATOR
References: