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Genomic Profiling in Recommending Treatment for Patients With Metastatic Solid Tumors

ConditionUnspecified Adult Solid Tumor, Protocol Specific
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Adult oncology clinic at the Stanford Cancer Institute

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • mutation analysis

    Genetic

    Correlative studies

  • cytology specimen collection procedure

    Other intervention

    Correlative studies

  • laboratory biomarker analysis

    Other intervention

    Correlative studies

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Ancillary-correlative (tumor genomic profiling)3 interventions

Trial outcomes

Primary outcomes

1

Feasibility, measured as the proportion of patients with at least one actionable alteration

An actionable alteration is defined as availability of targeted therapy, scored as: A) an FDA-approved drug, B) an FDA-approved drug in another tumor type, or C) a drug that is not yet approved but has a clinical trial open. The percentage of patients in the "profile" arm with successful profiling will be calculated and further characterized by availability category.

Time frame
Baseline

Secondary outcomes

1

Drugs (if any) that target alterations found in a patient's tumor material at baseline, as identified by the Molecular Tumor Board

Time frame
Baseline
2

Drugs (if any) that target alterations found in a patient's peripheral blood at baseline, as identified by the Molecular Tumor Board

Time frame
Baseline
3

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

Time frame
Baseline
4

Overall survival

Overall survival of patients in each cohort will be characterized using Kaplan-Meier plots and the two cohorts will be compared using a Cox model to control for age and sex.

Time frame
Number of days from enrollment to death, assessed up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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