Evaluating genomic testing for cancer treatment outcomes

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 clinical trial assesses the effectiveness of targeted therapies based on genomic analysis in patients with refractory metastatic cancer. It is a single-arm, prospective trial where patients receive treatment selected by the Markey Cancer Center Molecular Tumor Board. The study compares the progression-free survival of patients on this new regimen to their previous treatment regimen where they experienced disease progression, effectively using patients as their own control. The goal is to determine if genomic-guided therapy can improve outcomes for these patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with clinically suspected or histologically confirmed solid or hematological malignancy who have undergone or will undergo genetic testing of their tumor
* Patients must have failed first-line therapy for their disease (refractory) or have no options for curative therapies.
* Patients must have either measurable or non-measurable disease.
* Age ≥18 years.
* Eastern Cooperative Oncology Group performance status ≤3.
* Patients with brain metastasis must have had treatment of their brain metastasis completed at least 1 day prior to enrollment and be on stable dose of steroids or off steroids at the time of enrollment.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician.
* Pregnant women are excluded from this study.
* HIV positive patients with CD4 counts below 500 OR who are not on a stable dose of antiretroviral therapy (for at least 1 month prior to registration) are ineligible.

Where it's running

• Markey Cancer Center, University of Kentucky
  Lexington, Kentucky, United States Recruiting

Study contacts

• Principal investigator: Rachel Miller, Md — University of Kentucky
• Study coordinator: Rachel Miller, Md
• Email: raware00@uky.edu
• Phone: 859-323-2196

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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.