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Purpose

This is a substudy (Part 2) of a larger two-part clinical trial including both observational and therapeutic (interventional) cohorts to assess the progression free survival ratio of patients treated with a targeted therapy based on genomic analysis results and recommendation by the Markey Cancer Center Molecular Tumor Board (MCC MTB).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Therapeutic Intervention
Therapeutic Intervention
  • Drug: Therapeutic Intervention
    Therapeutic Intervention

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

Markey Cancer Center, University of Kentucky
Lexington, Kentucky 40536
Contact:
Rachel Miller, MD
859-323-2196
raware00@uky.edu

More Details

NCT ID
NCT03089554
Status
Recruiting
Sponsor
Rachel Miller

Study Contact

RACHEL MILLER, MD
859-323-2196
raware00@uky.edu

Detailed Description

This prospective, single-arm trial in patients with refractory metastatic cancer will compare the Progression Free Survival (PFS) using a treatment regimen selected by the MCC MTB with the PFS (time to tumor progression) for the most recent regimen on which the patient had experienced progression (i.e., using patients as their own control).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.