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Guided therapy for Neuroblastoma

N/A
Waitlist Available
Research Sponsored by Giselle Sholler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Neuroblastoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants That Are Able to Meet Feasibility Parameters.
Secondary study objectives
Activity of Treatments Chosen Based on Progression Free Survival (PFS)
Number of Participants With Adverse Events as a Measure of Safety
Overall Response Rate (ORR) of Participants Using RECIST Criteria

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Guided therapyExperimental Treatment1 Intervention
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 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Guided Therapy
2011
N/A
~210

Find a Location

Who is running the clinical trial?

Giselle ShollerLead Sponsor
22 Previous Clinical Trials
2,474 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,847 Patients Enrolled for Neuroblastoma
Wake Forest University Health SciencesLead Sponsor
1,395 Previous Clinical Trials
2,460,189 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,819 Patients Enrolled for Neuroblastoma
Giselle SaulnierShollerLead Sponsor
21 Previous Clinical Trials
2,389 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,762 Patients Enrolled for Neuroblastoma
~1 spots leftby Nov 2025
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