Spots Global Cancer Trial Database for Ex Vivo Drug Sensitivity Testing and Mutation Profiling

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Trial Identification

Brief Title: Ex Vivo Drug Sensitivity Testing and Mutation Profiling

Official Title: Personalized Ex Vivo Drug Screening and Genomics Profiling to Guide Individualized Treatments for Children With Relapsed or Refractory Solid Tumors and Leukemias

Study ID: NCT03860376

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

Interventions

Study Description

Brief 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.

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 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.