Individualized Treatments in Adults With Relapsed/Refractory Cancers

• ClinicalTrials.gov Identifier: NCT06024603
• Recruitment Status: Recruiting
• First Posted: September 6, 2023
• Last Update Posted: April 23, 2024
• Sponsor: Case Comprehensive Cancer Center
• Collaborators: Florida International University; Community Foundation of Broward
• Information provided by (Responsible Party): Case Comprehensive Cancer Center

Tracking Information

• First Submitted Date: July 28, 2023
• First Posted Date: September 6, 2023
• Last Update Posted Date: April 23, 2024
• Actual Study Start Date: November 20, 2023
• Estimated Primary Completion Date: November 1, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 1, 2023)

• 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%).
• 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%).

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: October 19, 2023)

• 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.
• 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.
• 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).

Original Secondary Outcome Measures (submitted: September 1, 2023)

• 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 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 [ Time Frame: 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Individualized Treatments in Adults With Relapsed/Refractory Cancers
• Official Title: Individualized Treatments in Adults With Relapsed/Refractory Cancers
• 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.
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Refractory Cancer
• Relapsed Cancer

Intervention

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.

Study Arms

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.

Intervention: Diagnostic Test: Drug Sensitivity Test (DST)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 1, 2023): 36
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 1, 2025
• Estimated Primary Completion Date: November 1, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Jorge Manrique-Succar, MD; (954) 659-5000; manriqj@ccf.org

Contact: Diana Azzam, PhD; 305-348-9043; dazzam@fiu.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06024603
• Other Study ID Numbers: CASE5Y22
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Case Comprehensive Cancer Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Case Comprehensive Cancer Center
• Original Study Sponsor: Same as current

Collaborators

• Florida International University
• Community Foundation of Broward

Investigators

• 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

• PRS Account: Case Comprehensive Cancer Center
• Verification Date: April 2024