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Individualized Treatments in Adults With Relapsed/Refractory Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06024603
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : April 23, 2024
Sponsor:
Collaborators:
Florida International University
Community Foundation of Broward
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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Brief Summary:
A personalized cancer medicine approach would address therapy resistance, cancer metastasis, and limited options after standard of care is exhausted in advanced cancer participants. This approach may reduce the barriers to approved therapeutic assignment currently limited to a particular cancer type or patient demographic.

Condition or disease Intervention/treatment Phase
Refractory Cancer Relapsed Cancer Diagnostic Test: Drug Sensitivity Test (DST) Not Applicable

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. The physician will decide the most appropriate treatment for each case, with the option to add one or more personalized (assay-guided) drug(s) from the investigational platform. All participants will need to be consented separately for any subsequent investigational treatment if no standard treatment options are available.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Individualized Treatments in Adults With Relapsed/Refractory Cancers
Actual Study Start Date : November 20, 2023
Estimated Primary Completion Date : November 1, 2025
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Medicines

Arms and Interventions
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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. 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 tissue 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.


Outcome Measures
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Primary Outcome Measures :
  1. Treatment recommendation feasibility [ Time Frame: 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%).

  2. Treatment recommendation feasibility [ Time Frame: 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 :
  1. Treatment responsiveness [ Time Frame: 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 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.

  2. Progression-free survival [ Time Frame: Up tp 1 year post-treatment ]
    Progression-free survival will be measured by comparing individual outcomes of 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.

  3. Progression-free survival ratio [ Time Frame: Up to 1 year post-treatment ]
    We will assess changes in progression-free survival from each patient's previous treatment versus their progression-free survival from the treatment assigned during the trial. Assessments will be made both in the DST-guided cohort and the non-DST-guided (conventional) cohort. Analysis will include both the raw ratio as well as the number of incidences of 30% improved PFS on trial versus previous regimen (PFS2/PFS1 > 1.3x).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants aged 18 years or older at the time of enrollment on this study of any gender, race, or ethnicity.
  • Patients with suspected or confirmed diagnosis of recurrent or refractory cancer.
  • Participants who have undergone at least two lines of previous therapy.
  • Participants who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone marrow aspirate (blood cancers).
  • Participants willing to have a blood draw or buccal swab done for the purposes of genetic testing.
  • Participants willing to sign informed consent.

Exclusion Criteria:

  • Participants who do not have malignant tissue available and accessible.
  • Participants for whom the amount of excised malignant tissue is not sufficient for the ex vivo drug testing and/or genetic profiling.
  • Participants with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe standard therapy.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06024603


Contacts
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Contact: Jorge Manrique-Succar, MD (954) 659-5000 manriqj@ccf.org
Contact: Diana Azzam, PhD 305-348-9043 dazzam@fiu.edu

Locations
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United States, Florida
Florida International University Recruiting
Miami, Florida, United States, 33199
Contact: Diana Azzam, PhD    305-348-9043    dazzam@fiu.edu   
Principal Investigator: Diana Azzam, PhD         
Lerner College of Medicine, Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
Contact: Jillian King    954-299-5798    kingj19@ccf.org   
Contact: Kaitlin Bernabe    954-659-5000 ext 56449    BERNABK@ccf.org   
Principal Investigator: Jorge Manrique-Succar, MD         
Sub-Investigator: Elizabeth Stone, MD         
Sub-Investigator: Chebli Mrad, MD         
Sub-Investigator: Badih Adada, MD         
Sub-Investigator: Rafael Arleta-Bulos, MD         
Sub-Investigator: Diana Saravia, MD         
Sub-Investigator: Arun Nagarajan, MD         
Sub-Investigator: Thomas Samuel, MD         
Sub-Investigator: Chakra Chaulagain, MD         
Sub-Investigator: Chieh-Lin Fu, MD         
Sub-Investigator: Amer Hanano, MD         
Sub-Investigator: Candice Schwartz, MD         
Sub-Investigator: Mariana Berho, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Florida International University
Community Foundation of Broward
Investigators
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Principal Investigator: Jorge Manrique-Succar, MD Lerner College of Medicine, Cleveland Clinic Florida
Principal Investigator: Diana Azzam, PhD Robert Stempel College of Public Health and Social Work, Florida International University
More Information
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT06024603    
Other Study ID Numbers: CASE5Y22
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: April 23, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No