Ex Vivo Drug Sensitivity Testing and Multi-Omics Profiling

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.

Conditions

• 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

Interventions

DEVICE

Functional Precision Medicine

Ex Vivo Drug Sensitivity Testing + Genomic Tumor Profiling

Sponsors & Collaborators

• Nicklaus Children's Hospital f/k/a Miami Children's Hospital

  collaborator OTHER

• First Ascent Biomedical Inc.

  collaborator INDUSTRY

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• Florida International University

  lead OTHER

Principal Investigators

• Diana Azzam · Florida International University

• Maggie Fader · Nicklaus Children's Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Day

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-02-22

Primary Completion

2028-02-22

Completion

2028-12-31

Countries

• United States

Study Locations