Individualized Treatments in Adults With Relapsed/Refractory Cancers
Study Details
Study Description
Brief Summary
Resistance to most chemotherapeutic regimens continues to be a major problem, leading to refractory cancer and relapse. In addition, there are major gaps in understanding of the molecular hallmarks and drivers of advanced and metastatic cancers, with limited whole genome sequencing data or longitudinal profiling available to understand genomic drivers of metastasis and therapy resistance. A personalized cancer medicine approach would address therapy resistance and cancer metastasis in advanced cancer participants, eliminating the need to limit treatment improvements to a particular cancer type or patient demographic.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Treatment itself will not be given as part of this trial. The results of the drug sensitivity test (DST) and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. Standard therapy will be implemented, when possible, with an option to add the personalized (most effective response in vitro) drug from the investigational platform for enhanced treatment in participants. The physician will decide which treatment will be most appropriate for each case. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Drug Sensitivity Testing The results of the DST and genomic screening will be used to inform treating physician about participant-specific drug sensitivity or resistance guiding best therapy choices. Standard therapy will be implemented, when possible, with an option to add the personalized (most effective response in vitro) drug from the investigational platform for enhanced treatment in participants. The physician will decide which treatment will be most appropriate for each case. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available. |
Diagnostic Test: Drug Sensitivity Test (DST)
Refractory cancer cells will be collected from participants and subjected to single-drug testing while DNA is simultaneously sent for targeted gene sequencing. Drug sensitivity scores from the tests will become available for a final list of therapeutic options ranked best in order of preference together with suggested doses and schedules.
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Outcome Measures
Primary Outcome Measures
- Treatment recommendation feasibility [Up to 4 weeks post-treatment]
Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on ex vivo drug sensitivity testing (DST). Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).
- Treatment recommendation feasibility [Up to 4 weeks post-treatment]
Primary objective is to determine feasibility of providing treatment recommendations to relapsed and refractory adult cancer patients based on genomic profiling. Feasibility will be demonstrated if it is possible to recommend treatment within 4 weeks in at least 22 of 36 participants (62.5%).
Secondary Outcome Measures
- Treatment responsiveness [Up tp 1 year post-treatment]
Treatment responsiveness will be measured by comparing individual outcomes of adult participants with relapsed and refractory cancers treated with DST-guided therapy to non-DST guided (conventional) therapy. To address this goal, the overall response rate will be calculated. A responder to the treatment will be defined as any patient who achieves a best response of "partial response" or complete response" during the study period.Evaluable patients who demonstrate a complete or partial response confirmed by physician's review before receiving non-protocol anti- cancer therapy will be considered a responder. All other evaluable patients will be considered non- responder. Outcomes will be observed during treatment and follow-up for one year post-treatment or until disease progression, death, or withdrawal, whichever occurs first.
- Disease-free survival [Up tp 1 year post-treatment]
Disease-free survival will be measured by comparing individual outcomes of adult participants with relapsed and refractory cancers treated with DST-guided therapy to non-DST guided (conventional) therapy. DFS will be defined as time from start of treatment to even (treatment failure, relapse, second malignancy, death) or last follow-up for those who are event-free. Outcomes will be observed during treatment and follow-up for one year post-treatment or until disease progression, death, or withdrawal, whichever occurs first.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants aged 18 years or older at the time of enrollment on this study of any gender, race, or ethnicity.
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Patients with suspected or confirmed diagnosis of recurrent or refractory cancer.
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Participants who have undergone at least two lines of previous therapy.
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Participants who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers).
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Participants willing to have a blood draw or buccal swab done for the purposes of genetic testing.
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Participants willing to sign informed consent.
Exclusion Criteria:
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Participants who do not have malignant tissue available and accessible.
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Participants for whom the amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
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Participants with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lerner College of Medicine: Cleveland Clinic Florida | Weston | Florida | United States | 33331 |
Sponsors and Collaborators
- Case Comprehensive Cancer Center
Investigators
- Principal Investigator: Jorge Manrique-Succar, MD, Lerner College of Medicine, Cleveland Clinic Florida
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CASE5Y22