MedTrace Logo

Molecular-Guided Therapy for Relapsed and Refractory Childhood Cancer

NCT01802567 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-08-06

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to test the feasibility (ability to be done) of experimental technologies to determine a tumor's molecular makeup (gene expression profile) and mutations. This technology called the "Pediatric Gene Analysis Platform" includes a genomic report (gene expression profile) and a DNA Mutation Panel Report that are being used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer in the future.

Conditions

Interventions

DEVICE

Guided Therapy- Pediatric Gene Analysis Platform

A total of 48 neuroblastoma, brain tumor, and rare tumor patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).

Sponsors & Collaborators

  • Dell, Inc.

    collaborator INDUSTRY

  • Giselle Sholler

    lead OTHER

Principal Investigators

  • Giselle Sholler, MD · Beat Childhood Cancer at Atrium Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
13 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-04
Primary Completion
2024-01-17
Completion
2024-01-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01802567 on ClinicalTrials.gov