Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

Part of paid clinical trials in Miami, Florida.

Sponsor
Florida International University
Study ID
NCT05857969
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Childhood Brain Tumor
  • Recurrent Childhood Brainstem Glioma
  • Recurrent Childhood Ependymoma
  • Recurrent Childhood Gliosarcoma
  • Recurrent Childhood Large Cell Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent Childhood Malignant Neoplasm
  • Recurrent Childhood Malignant Solid Neoplasm
  • Recurrent Childhood Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Refractory Childhood Acute Lymphoblastic Leukemia
  • Refractory Childhood Hodgkin Lymphoma
  • Refractory Childhood Malignant Germ Cell Neoplasm
  • Refractory Childhood Malignant Neoplasm
  • Refractory Childhood Malignant Solid Neoplasm
  • Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Eligibility Criteria

Sex
ALL
Age
1 Day - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Functional Precision Medicine — DEVICE
    Ex Vivo Drug Sensitivity Testing + Genomic Tumor Profiling

Study Details

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.

Key Dates

Start date
Feb 22, 2023
Status verified
Jul 2025
Primary completion
Feb 22, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Functional Precision Medicine for Chemorefractory or relapsed patients
    We intend to enroll chemorefractory or relapsed pediatric patients with all types of cancers where tumor tissue would be available for functional precision medicine that integrates ex vivo drug screening and genomic profiling. The results of the drug sensitivity assay and genetic screening will be used to inform treating physician about patient-specific drug sensitivity or resistance guiding best therapy choices.

Primary Outcome Measure

Percentage of Patients that receive Functional Precision Medicine (FPM)-guided treatment options [ Time Frame: Up to 6 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nicklaus Children's HospitalMiamiFlorida33155
Darika Sartmatova
[email protected]
800-533-1792
Lillian Garvin
[email protected]
800-533-1792

Find similar trials in Miami, FL

By research site
Nicklaus Children's Hospital· Miami, FL

Related Studies