Using genomic profiling to recommend cancer treatment for patients with metastatic tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research focuses on the use of genomic profiling to guide treatment recommendations for patients with metastatic solid tumors. By analyzing the DNA of tumors, the study aims to identify genetic changes that could inform more effective treatment options. The primary objective is to assess the feasibility of integrating genomic profiling into clinical practice at the Stanford Cancer Institute, while secondary objectives include evaluating the prevalence of actionable genomic changes and the clinical benefits of therapies based on genomic data. Participants will undergo tissue and blood sample collection for analysis, with follow-up assessments conducted over two years.

Why it matters

Who can join: the full rules

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

Where it's running

• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Principal investigator: James M Ford, MD — Stanford University
• Study coordinator: Rozelle Laquindanum
• Email: rlaquind@stanford.edu
• Phone: (650) 724-9948

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.