Genomic Profiling in Recommending Treatment for Patients With Metastatic Solid Tumors

NCT02215928 | Recruiting DMC

• 2 other identifiers: IRB-29525NCI-2014-01662
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

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.

  Baseline

Secondary Outcomes (8)

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

  Baseline

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

  Baseline

• 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

  Baseline

• Overall survival

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

• Clinical response rate, assessed according to RECIST 1.1 criteria

  Up to 24 months

Study Arms (1)

Ancillary-correlative (tumor genomic profiling)

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.

Genetic: mutation analysis; Other: cytology specimen collection procedure; Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Ancillary-correlative (tumor genomic profiling)

mutation analysis GENETIC

Correlative studies

Ancillary-correlative (tumor genomic profiling)

cytology specimen collection procedure OTHER

Correlative studies

Also known as: cytologic sampling

Ancillary-correlative (tumor genomic profiling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult oncology clinic at the Stanford Cancer Institute

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

liquid biopsy

Study Officials

• James M Ford, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rozelle Laquindanum

CONTACT

(650) 724-9948; rlaquind@stanford.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2014
• First Posted: August 13, 2014
• Study Start: July 28, 2014
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (1)