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Genomic Analysis

Molecular-Guided Therapy for Childhood Cancer

N/A
Waitlist Available
Research Sponsored by Giselle SaulnierSholler
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current disease state must have no known curative therapy
Subjects must have histologically proven neuroblastoma, brain tumor, or rare tumor with confirmation of refractory or recurrent disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing new technology that could help doctors better understand a patient's individual cancer and predict the best treatments.

Who is the study for?
This trial is for children and young adults (aged >12 months and ≤21 years at diagnosis) with certain types of cancer, such as neuroblastoma or brain tumors, that have come back or haven't responded to treatment. They should not have a known cure available and must be able to perform daily activities more than half the time. Their liver function needs to be fairly normal, girls who can have babies need a negative pregnancy test, and their disease must be measurable on scans.Check my eligibility
What is being tested?
The study is testing an experimental 'Pediatric Gene Analysis Platform' which looks at the genetic makeup of tumors in kids with cancer. The goal is to see if this technology can help understand these cancers better and guide future treatments by predicting what might work best for each patient.See study design
What are the potential side effects?
Since this trial focuses on analyzing genetic information rather than testing new drugs directly, there are no direct side effects from interventions like you'd expect with medication. However, procedures involved in collecting tissue samples may carry risks typical of surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is considered incurable with current treatments.
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My cancer is a confirmed case of neuroblastoma, brain tumor, or a rare tumor that has come back or didn't respond to treatment.
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My liver tests are within the required range.
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I was diagnosed with my condition before turning 22 and am older than 1 year now.
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I can do most activities but need help with some.
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I have a cancerous area larger than 1 cm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Days to treatment will be used in order to determine feasibility of using tumor samples to assess genomic mRNA expression arrays and DNA Mutation Panels using predictive modeling
Secondary outcome measures
Number of Participants with Adverse Events as a Measure of Safety
Overall Response Rate (ORR) of Participants by the presence of radiologically assessable disease by cross-sectional CT or MRI imaging and/or by MIBG or PET scans.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Guided Therapy- Pediatric Gene Analysis PlatformExperimental Treatment1 Intervention
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).

Find a Location

Who is running the clinical trial?

Giselle SaulnierShollerLead Sponsor
21 Previous Clinical Trials
2,170 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,543 Patients Enrolled for Neuroblastoma
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,135 Total Patients Enrolled
19 Trials studying Neuroblastoma
1,600 Patients Enrolled for Neuroblastoma
Giselle ShollerLead Sponsor
21 Previous Clinical Trials
2,157 Total Patients Enrolled
18 Trials studying Neuroblastoma
1,530 Patients Enrolled for Neuroblastoma

Media Library

Pediatric Gene Analysis Platform (Genomic Analysis) Clinical Trial Eligibility Overview. Trial Name: NCT01802567 — N/A
Neuroblastoma Research Study Groups: Guided Therapy- Pediatric Gene Analysis Platform
Neuroblastoma Clinical Trial 2023: Pediatric Gene Analysis Platform Highlights & Side Effects. Trial Name: NCT01802567 — N/A
Pediatric Gene Analysis Platform (Genomic Analysis) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01802567 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical experiment being conducted in a multitude of locations within the city?

"At present, this research is being conduced at 13 locations across the United States. These facilities are located in Grand Rapids, Phoenix and Kansas City among other cities; it may be beneficial to choose the closest one so as to decrease travel time if you decide to take part."

Answered by AI

Is this trial still recruiting participants?

"Contrary to what is posted on clinicaltrials.gov, this particular trial has ceased recruitment for participants since April 20th 2022. Although the study no longer requires volunteers, there are still 302 other studies in need of subjects as of now."

Answered by AI

Who else is applying?

What site did they apply to?
Rady Children's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Recent research and studies
clinicaltrials.govStudy
Molecular-Guided Therapy for Relapsed and Refractory Childhood Cancer
Giselle Sholler 2013. "Molecular-Guided Therapy for Relapsed and Refractory Childhood Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01802567.
All > Neuroblastoma > Medulloblastoma
~4 spots leftby Apr 2025
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