A Trial Using Molecular-Guided Therapy in Patients With Refractory or Recurrent Neuroblastoma
The investigators are studying new ways to make treatment decisions for these types of cancer. Technologies at the Van Andel Research Institute (VARI) are available to determine a tumor's molecular makeup (gene expression profile). This technology (called "Xenobase") is being used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer. The researchers at VARI have filed a patent on the Xenobase and the specific network analysis method that the investigators will be using as part of this study.
A specimen obtained from the tumor during a recent surgical, biopsy, or bone marrow procedure will be sent to the Van Andel Research Institute. Researchers will attempt to identify the molecular makeup within the specimen, as well as in blood and urine samples in patients with aggressive and/or refractory cancer. This additional testing is different than the routine tests currently performed at the hospital for the evaluation of cancer.
The goals of this part of the study are: To determine if the investigators tumor board committee (at minimum a panel of 3 oncologists and 1 pharmacist) can use patient specific cancer cells to make real-time treatment decision using patient specific genetic information, and predicted therapies generated in the Xenobase report.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Trial Testing the Feasibility of Using Molecular-Guided Therapy in Patients With Refractory or Recurrent Neuroblastoma|
- Feasibility of using protocol process to make real time treatment decisions [ Time Frame: 4 months ] [ Designated as safety issue: No ]To pilot 5 patients to evaluate the feasibility of using predictive modeling based on genome-wide mRNA expression profiles of bone marrow derived neuroblastoma cells or tumor biopsies to make real-time treatment decisions.
|Study Start Date:||April 2010|
|Study Completion Date:||July 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109238
|United States, Vermont|
|Burlington, Vermont, United States, 05401|
|Study Chair:||Giselle Sholler, MD||University of Vermont|