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Clinical Trial Summary

This study is a prospective, non-randomized feasibility study. Freshly isolated tumor cells from patients will be screened using state-of-the-art viability assay designed for ex vivo high-throughput drug sensitivity testing (DST). In addition, genetic information will be obtained from cancer and normal (germline) tissue and correlated with drug response. This study will provide the platform for informing treating physician about individualized treatment options. The main outcome of this study will be the proportions of the patients whose treatment was guided by the personalized medicine approach.


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 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 DST-guided therapy as compared to non-DST guided (conventional) therapy. EXPLORATORY OBJECTIVE: To explore associations between genetic abnormalities in malignancies and ex vivo drug response. ;


Study Design


Related Conditions & MeSH terms

  • Ependymoma
  • Gliosarcoma
  • Leukemia
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Lymphoma
  • 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 NCT03860376
Study type Observational
Source Florida International University
Contact
Status Completed
Phase
Start date February 21, 2019
Completion date December 31, 2022

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