← Back to Search

Genomic Profiling

Molecular-Guided Therapy for Childhood Cancer

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
Adequate liver function must be demonstrated, defined as: Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND ALT (SGPT) < 10 x upper limit of normal (ULN) for age
Subjects must have proven pediatric cancer with confirmation at diagnosis or at the time of recurrence/progression and clinical determination of disease for which there is no known effective curative therapy or disease that is refractory to established proven therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing if new technology that decodes a tumor's DNA can help docs better understand cancer & predict treatment.

Who is the study for?
This trial is for children and young adults up to 21 years old with various types of cancer, including brain tumors and sarcomas, who have no known effective curative therapy available or whose disease is resistant to current treatments. Participants must be in a certain health condition (Lansky/Karnofsky Score ≥ 50) and agree to use effective birth control if applicable.Check my eligibility
What is being tested?
The study aims to test new experimental technologies that analyze the molecular characteristics of tumors using DNA exomes and RNA sequencing. The goal is to better understand pediatric cancers and find personalized treatment options based on each tumor's unique profile.See study design
What are the potential side effects?
Since this trial focuses on feasibility testing of diagnostic technologies rather than direct therapeutic interventions, specific side effects are not detailed here. However, any procedures involved in obtaining tissue samples may carry risks like infection or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My liver functions within normal limits.
Select...
My child's cancer cannot be cured with known treatments or has not responded to standard therapies.
Select...
My cancer can be seen and measured on scans, and it's possible to take a biopsy.
Select...
My white blood cell count is high enough to start treatment.
Select...
My brain condition is stable, and I haven't needed more medicine for it in the last 2 weeks.
Select...
I can do most activities but need help with some.
Select...
I am older than 12 months.
Select...
I was 21 years old or younger when first diagnosed.
Select...
I am a woman capable of becoming pregnant and have a negative pregnancy test.
Select...
I agree to use effective birth control during and 6 months after treatment.
Select...
My condition has no known effective treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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 sequencing using predictive modeling to make real-time treatment decisions for children with relapsed/refractory cancers.
Secondary outcome measures
Biology studies to include: genomic analysis of cells pre- and post- treatment, correlation of in vitro response to in vivo response, sub analysis examination of disease types, and biomarker development.
Duration of response will be objectively documented
Number of Participants with Adverse Events as a Measure of Safety
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Guided TherapyExperimental Treatment1 Intervention
A total of 200 neuroblastoma, brain tumor, and rare tumor patients 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
~20

Find a Location

Who is running the clinical trial?

Giselle ShollerLead Sponsor
21 Previous Clinical Trials
2,019 Total Patients Enrolled
Giselle SaulnierShollerLead Sponsor
21 Previous Clinical Trials
2,032 Total Patients Enrolled
Translational Genomics Research InstituteOTHER
35 Previous Clinical Trials
106,851 Total Patients Enrolled

Media Library

Guided Therapy (Genomic Profiling) Clinical Trial Eligibility Overview. Trial Name: NCT02162732 — N/A
Neuroectodermal Tumors Research Study Groups: Guided Therapy
Neuroectodermal Tumors Clinical Trial 2023: Guided Therapy Highlights & Side Effects. Trial Name: NCT02162732 — N/A

Frequently Asked Questions

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

Is it currently possible to join this research endeavor?

"Based on the information provided by clinicaltrials.gov, this experiment is not currently enrolling candidates. Despite first being posted June 1st 2014 and last edited April 20th 2022, no patient are presently being recruited for this trial but there are 1253 other studies that require volunteers at present."

Answered by AI

Who is able to sign up for the experiment?

"This clinical trial is recruiting 184 participants with clear cell sarcoma of soft tissue in the age range of 13 Months - 21. To be eligible, individuals must have been diagnosed with Medulloblastomas (At relapse after accepted curative therapy), Ependymomas (At relapse following standard care or non-responsive/progressive to treatment), Brain Tumors and Neuroblastoma (Post high risk therapy relapsed patients or MYCN amplified patient over 15 months old). Candidates shall also need to fulfill other criteria including post-standard chemotherapy progression or lack of efficacy for accepted treatments."

Answered by AI

Is the upper age limit for recruitment into this trial lower than 85 years?

"Subjects aged between 13 Months and 21 years are currently being sought for this trial."

Answered by AI

Where are the venues wherein this clinical experiment is taking place?

"As part of this medical trial, patients can be enrolled at Penn State Milton S. Hershey Medical Center and Children's Hospital in Hershey, Pennsylvania, Helen DeVos Children's Hospital in Grand Rapids, Michigan and Connecticut Children's Hospital in Hartford as well as 18 other sites nationwide."

Answered by AI
~20 spots leftby Jun 2025