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Platinum-based Chemotherapy
High-Dose Chemotherapy + Stem Cell Transplant for Neuroblastoma
N/A
Waitlist Available
Led By Ashish Gupta, MBBS, MPH
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is for children with high-risk neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.
Who is the study for?
This trial is for children with high-risk neuroblastoma who haven't shown disease progression and have recovered from previous chemotherapy. They must have enough harvested stem cells for transplant, no uncontrolled infections, normal liver and heart function, adequate kidney function, and be under 30 years old at diagnosis.Check my eligibility
What is being tested?
The treatment involves high-dose chemotherapy drugs (Etoposide, Melphalan, Carboplatin), followed by an autologous stem cell infusion to restore bone marrow. Isotretinoin is used post-chemotherapy to kill any remaining cancer cells along with radiation therapy if needed.See study design
What are the potential side effects?
Possible side effects include low blood counts leading to infection risk or bleeding problems; nausea; vomiting; hair loss; organ damage due to high drug doses; mouth sores from isotretinoin; fatigue and skin reactions from radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Patients with Successful Engraftment
Secondary outcome measures
Number of Patients with Disease Free Survival
Number of Patients with Treatment Related Death
Overall Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients Treated for NeuroblastomaExperimental Treatment7 Interventions
According to patient weight and renal function, consolidation chemotherapy using various doses of Melphalan, Etoposide, and Carboplatin followed by autologous stem cell infusion and serial post-transplant Granulocyte Colony Stimulating Factor, radiation therapy and Isotretinoin maintenance therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isotretinoin (13-cis-retinoic acid)
2012
N/A
~20
Etoposide
2010
Completed Phase 3
~2440
Radiation therapy
2013
Completed Phase 3
~2850
Autologous stem cell infusion
2009
Completed Phase 1
~90
Granulocyte colony stimulating factor
2012
N/A
~20
Melphalan
2008
Completed Phase 3
~1500
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
271 Previous Clinical Trials
14,612 Total Patients Enrolled
4 Trials studying Neuroblastoma
129 Patients Enrolled for Neuroblastoma
Ashish Gupta, MBBS, MPHPrincipal InvestigatorMasonic Cancer Center, University of Minnesota
3 Previous Clinical Trials
81 Total Patients Enrolled
1 Trials studying Neuroblastoma
12 Patients Enrolled for Neuroblastoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- If your disease is getting worse, you may want to consider participating in earlier stage studies as the treatment in this trial has not been proven to stop the disease from progressing.You were diagnosed with neuroblastoma before you turned 30 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Patients Treated for Neuroblastoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the participant capacity of this investigation?
"Correct. According to clinicaltrials.gov, this medical investigation is actively accepting new participants since its initial posting on March 28th 2012 and most recent update on April 11th 2022. The study requires 20 enrollees from a single site."
Answered by AI
Is there prior research indicating the effectiveness of this treatment?
"At the time of writing, there are 1067 medical studies in progress focusing on this treatment; 299 trials have progressed to Phase 3. Most of these research initiatives are located in Shanghai, but a total of 56023 clinical trial sites around the world offer access to it."
Answered by AI
Is this research currently enrolling participants?
"Affirmative. The clinicaltrials.gov website reveals that this experiment is currently recruiting participants, having been initially posted on March 28th 2012 and last updated on April 11th 2022. With 1 site in operation, 20 volunteers are required for the trial to proceed."
Answered by AI
What medical conditions does this therapy typically address?
"This therapy has been proven to effectively tackle the initial stages of prostate and small cell lung cancer."
Answered by AI
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