Clinical trial NCT06024603: Individualized Treatments in Adults With Relapsed/Refractory Cancers
Official title: Individualized Treatments in Adults With Relapsed/Refractory Cancers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Refractory Cancer
Relapsed Cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Florida International University
name: Community Foundation of Broward
First posted: 2023-09-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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 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.

Primary outcomes:
measure: Treatment recommendation feasibility
timeFrame: Up to 4 weeks post-treatment
measure: Treatment recommendation feasibility
timeFrame: Up to 4 weeks post-treatment
Secondary outcomes:
measure: Treatment responsiveness
timeFrame: Up tp 1 year post-treatment
measure: Progression-free survival
timeFrame: Up tp 1 year post-treatment
measure: Progression-free survival ratio
timeFrame: Up to 1 year post-treatment
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
city: Weston
country: United States
facility: Lerner College of Medicine, Cleveland Clinic Florida
state: Florida
Study officials:
affiliation: Lerner College of Medicine, Cleveland Clinic Florida
name: Jorge Manrique-Succar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Stempel College of Public Health and Social Work, Florida International University
name: Diana Azzam, PhD
role: PRINCIPAL_INVESTIGATOR
References: