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Trial Title:
Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling
NCT ID:
NCT05857969
Condition:
Recurrent Childhood Acute Myeloid Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Large Cell Lymphoma
Refractory Childhood Acute Lymphoblastic Leukemia
Refractory Childhood Hodgkin Lymphoma
Refractory Childhood Malignant Germ Cell Neoplasm
Recurrent Childhood Brain Tumor
Recurrent Childhood Brainstem Glioma
Recurrent Childhood Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Recurrent Childhood Ependymoma
Recurrent Childhood Lymphoblastic Lymphoma
Recurrent Childhood Gliosarcoma
Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Refractory Childhood Malignant Solid Neoplasm
Recurrent Childhood Malignant Solid Neoplasm
Recurrent Childhood Malignant Neoplasm
Refractory Childhood Malignant Neoplasm
Conditions: Official terms:
Lymphoma
Leukemia
Neoplasms
Sarcoma
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Rhabdomyosarcoma
Ependymoma
Gliosarcoma
Neoplasms, Germ Cell and Embryonal
Recurrence
Conditions: Keywords:
ex vivo drug sensitivity assay
genomic profiling
Functional precision medicine
Biomarker development
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Summary:
Functional precision medicine (FPM) is a relatively new approach to cancer therapy based
on direct exposure of patient- isolated tumor cells to clinically approved drugs and
integrates ex vivo drug sensitivity testing (DST) and genomic profiling to determine the
optimal individualized therapy for cancer patients. In this study, we will enroll
relapsed or refractory pediatric cancer patients with tissue available for DST and
genomic profiling from the South Florida area, which is 69% Hispanic and 18% Black. Tumor
cells collected from tissue taken during routine biopsy or surgery will be tested.
Detailed description:
PRIMARY OBJECTIVE: The primary objective of the study is to determine feasibility of
providing pediatric cancer patients with access to personalized treatment options and
clinical management recommendations based on Functional Precision Medicine (FPM), the
combination of ex vivo drug sensitivity testing (DST) and genomic profiling.
SECONDARY OBJECTIVE: The secondary objective of the study is to compare individual
outcomes (response and disease-free survival) in patients with pediatric cancers treated
with FPM-guided therapy as compared to non-FPM guided (conventional) therapy.
EXPLORATORY OBJECTIVE: To explore associations between tumor molecular characteristics
(genomic and transcriptomic variation) and ex vivo drug response with respect to patient
ethnicity.
Criteria for eligibility:
Study pop:
Chemorefractory and/or relapsed pediatric cancer patients with no alternative treatment
options.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients aged 21 years or younger at the time of enrollment on this study of any
gender, race or ethnicity.
Subjects with suspected or confirmed diagnosis of recurrent or refractory cancer Subjects
who are scheduled for or have recently had biopsy or tumor excised (solid tumors) or bone
marrow aspirate (blood cancers) Subjects willing to have a blood draw or buccal swab done
for the purposes of genetic testing Subjects or their parents or legal guardians willing
to sign informed consent Subjects aged 7 to 17 willing to sign assent
Exclusion Criteria:
- Subjects who do not have malignant tissue available and accessible The amount of
excised malignant tissue is not sufficient for the ex vivo drug testing and/or
genetic profiling.
Patients with newly diagnosed tumors and tumors that have high (>90%) cure rate with safe
standard therapy.
Gender:
All
Minimum age:
1 Day
Maximum age:
21 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nicklaus Children's Hospital
Address:
City:
Miami
Zip:
33155
Country:
United States
Status:
Recruiting
Contact:
Last name:
Darika Sartmatova
Phone:
800-533-1792
Email:
exvivotrial@nicklaushealth.org
Contact backup:
Last name:
Lillian Garvin
Phone:
800-533-1792
Email:
exvivotrial@nicklaushealth.org
Start date:
February 22, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Florida International University
Agency class:
Other
Collaborator:
Agency:
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Agency class:
Other
Collaborator:
Agency:
First Ascent Biomedical, Inc.
Agency class:
Other
Collaborator:
Agency:
National Institute on Minority Health and Health Disparities (NIMHD)
Agency class:
NIH
Source:
Florida International University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05857969
