Evaluating Genomic Testing in Human Cancer & Outcomes of Targeted Therapies

Official title

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

Overview

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).

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).

Interventions

• Drug Therapeutic Intervention
  Therapeutic Intervention

Primary outcome measures

• Progression Free Survival [Time frame: 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Markey Cancer Center, University of Kentucky — Lexington

Publications

• Miller RW, Hutchcraft ML, Weiss HL, Wu J, Wang C, Liu J, Jayswal R, Buchanan M, Anderson A, Allison DB, El Khouli RH, Patel RA, Villano JL, Arnold SM, Kolesar JM. Molecular Tumor Board-Assisted Care in an Advanced Cancer Population: Results of a Phase II Clinical Trial. JCO Precis Oncol. 2022 Aug;6:e2100524. doi: 10.1200/PO.21.00524. PMID 36103643

Identifiers

NCT: NCT03089554 · MCC-16-MULTI-19

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗