Individualized Treatments in Adults With Relapsed/Refractory Cancers

NCT ID: NCT06024603

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-20

Study Completion Date

2025-11-30

Brief Summary

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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

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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.

Conditions

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Refractory Cancer Relapsed Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Drug Sensitivity Test (DST)

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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 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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Florida International University

OTHER

Sponsor Role collaborator

Community Foundation of Broward

UNKNOWN

Sponsor Role collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jorge Manrique-Succar, MD

Role: PRINCIPAL_INVESTIGATOR

Lerner College of Medicine, Cleveland Clinic Florida

Diana Azzam, PhD

Role: PRINCIPAL_INVESTIGATOR

Robert Stempel College of Public Health and Social Work, Florida International University

Locations

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Florida International University

Miami, Florida, United States

Site Status RECRUITING

Lerner College of Medicine, Cleveland Clinic Florida

Weston, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jorge Manrique-Succar, MD

Role: CONTACT

(954) 659-5000

Diana Azzam, PhD

Role: CONTACT

305-348-9043

Facility Contacts

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Diana Azzam, PhD

Role: primary

305-348-9043

Jillian King

Role: primary

954-299-5798

Kaitlin Bernabe

Role: backup

954-659-5000 ext. 56449

Other Identifiers

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CASE5Y22

Identifier Type: -

Identifier Source: org_study_id

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