NCT01802567

Molecular-Guided Therapy for Relapsed and Refractory Childhood Cancer

A Feasibility Trial Using Molecular-Guided Therapy for the Treatment of Patients With Relapsed and Refractory Childhood Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Giselle Sholler · Academic / Other
• Sex: All
• Age: 13 Months
• Healthy volunteers: Not accepted

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

• Neuroblastoma
• Medulloblastoma
• Brain Tumors
• Rare Tumors

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2013-03-04
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2013-03-01
• Last updated: 2024-08-06
• Results posted: 2024-04-26

Locations

13 sites across 1 country: United States