CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 16 enrolled
Drug / intervention
Guided Therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01355679
NCT01355679N/ACompleted

A Feasibility Trial Using Molecular-Guided Therapy for the Treatment of Patients With Refractory or Recurrent Neuroblastoma

Giselle Sholler·interventional·Posted May 18, 2011·Updated Aug 6, 2024

In Brief

A clinical study evaluating Guided Therapy for Neuroblastoma. Completed, enrolled 16 participants across 7 sites.

Detailed Summary

The purpose of this study is to test the feasibility (ability to be done) of an experimental test to help plan your cancer treatment. This study plan is not studying the effectiveness of the proposed combinations of therapy for your cancer that you may receive after the experimental testing. This study will look at an experimental technology to determine a tumor's molecular makeup (gene expression profile). This technology (called "OncInsights") is being used to discover new ways to understand cancers and potentially predict the best treatments for patients with cancer in the future. The experimental technology has not been approved by the U.S. Food and Drug Administration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeuroblastoma
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2011
Enrollment StartMay 1, 2011
Primary CompletionSep 1, 2013
Study CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 15.1 years ago

Interventions

Guided Therapydevice

A total of 14 eligible neuroblastoma 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 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).