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).
Recruiting
Phase 2
| Drug | Synonyms | Arms |
|---|---|---|
| Therapeutic Intervention | Therapeutic Intervention |
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).
| Name | Type | Description | Interventions |
|---|---|---|---|
| Therapeutic Intervention | Experimental | Therapeutic Intervention |
|
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.
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
| Measure: | Progression Free Survival |
| Time Frame: | 2 years |
| Safety Issue: | |
| Description: | Proportion of patients achieving a PFS ratio ≥1.3. |
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Rachel Miller |
June 22, 2021
