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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Ependymoma
  • Gliosarcoma
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Lymphoma
  • Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Recurrence
  • 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 Rhabdomyosarcoma
  • Recurrent Childhood Soft Tissue Sarcoma
  • Refractory Childhood Acute Lymphoblastic Leukemia
  • Refractory Childhood Hodgkin Lymphoma
  • Refractory Childhood Malignant Germ Cell Neoplasm
  • Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Rhabdomyosarcoma
  • Sarcoma

NCT number NCT05857969
Study type Observational
Source Florida International University
Contact Diana Azzam, PhD
Phone 305-348-9043
Email fpmlab@fiu.edu
Status Recruiting
Phase
Start date February 22, 2023
Completion date December 31, 2028

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