Individualized Treatments in Adults With Relapsed/Refractory Cancers

NCT06024603 | Active Not Recruiting

• 1 other identifier: CASE5Y22
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Refractory Cancer; Relapsed Cancer

Outcome Measures

Primary Outcomes (2)

• Treatment recommendation feasibility

  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%).

  Up to 4 weeks post-treatment

• Treatment recommendation feasibility

  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%).

  Up to 4 weeks post-treatment

Secondary Outcomes (3)

• Treatment responsiveness

  Up tp 1 year post-treatment

• Progression-free survival

  Up tp 1 year post-treatment

• Progression-free survival ratio

  Up to 1 year post-treatment

Study Arms (1)

Drug Sensitivity Testing

EXPERIMENTAL

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)

Interventions

Drug Sensitivity Test (DST) DIAGNOSTIC_TEST

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.

Drug Sensitivity Testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 with no curative treatment options.
• 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) or who have scheduled or recently had paracentesis or thoracentesis performed.
• Participants willing to have a blood draw or buccal swab done for the purposes of genetic testing.
• Participants willing to sign informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Florida International University: collaborator
• Community Foundation of Broward: collaborator

Study Sites (2)

Florida International University

Miami, Florida, 33199, United States

Location

Lerner College of Medicine, Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

MeSH Terms

Conditions

Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: September 6, 2023
• Study Start: November 20, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

US (2)