Evaluating genomic testing for cancer treatment outcomes

Integration of Precision Medicine Into Cancer Therapeutics, Part 2: A Therapeutic Phase 2 Sub-study Evaluating Genomic Testing in Human Cancer and Outcomes of Targeted Therapies Recommended by an Institutional Multidisciplinary Molecular Tumor Board in Patients With Poor Prognosis Cancer

This study tests if using genetic information to choose cancer treatments can help patients with hard-to-treat metastatic cancer live longer without their disease getting worse.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT03089554 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with refractory metastatic cancer who have undergone genetic testing of their tumors.

Not a fit: Patients who have recently received chemotherapy or radiotherapy may not benefit from this study due to the exclusion criteria.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes for patients with advanced cancer by personalizing therapy based on genetic information.

How similar studies have performed: Other studies have shown promising results with genomic-guided therapies, indicating potential success for this approach.

Eligibility criteria

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 this trial is running

Lexington, Kentucky

• 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

Conditions Cancer