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Chemotherapy
Treatment (131I-MIBG, chemotherapy) for Neuroblastoma
Phase 1
Waitlist Available
Led By Brian D Weiss
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 months (> 547 days) with unfavorable pathology, regardless of MYCN status
Patients with newly diagnosed INSS stage 2a/2b with MYCN amplification (> 4-fold increase in MYCN signals as compared to reference signals) and age >= 365 days, regardless of additional biologic features
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks after course 5 of induction
Awards & highlights
Study Summary
This trial is studying MIBG therapy and chemotherapy in treating patients with newly diagnosed high-risk neuroblastoma.
Who is the study for?
This trial is for children with high-risk neuroblastoma, a type of cancer. Eligible patients are those newly diagnosed with specific stages of the disease, have certain genetic features like MYCN amplification, and meet age requirements. They should not have had much prior treatment except possibly one round of chemotherapy or emergency radiation. Kidney function tests and heart function must be within acceptable ranges.Check my eligibility
What is being tested?
The study tests induction therapy including iobenguane I-131 (a radioactive drug) plus various chemotherapies followed by stem cell transplant and maintenance therapy with isotretinoin. The goal is to see if this combination can better kill tumor cells in these young patients.See study design
What are the potential side effects?
Possible side effects include damage to kidney or liver functions due to radioisotope therapy; heart problems; blood disorders from chemotherapy; risk of infection after stem cell transplant; and skin dryness or other issues related to isotretinoin.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 months and my cancer has unfavorable pathology.
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I am over 1 year old with a specific type of stage 2 neuroblastoma.
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My kidney function tests are within normal range for my age and gender.
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My neuroblastoma is newly diagnosed and classified as stage 4.
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My cancer shows a specific genetic change and I am over 1 year old.
Select...
My child's bilirubin level is less than or equal to 1.0 mg/dL.
Select...
My liver enzymes are within normal limits for my age.
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My creatinine level is equal to or less than 1.2 mg/dL, and I am between 10 and 13 years old.
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My kidney function is within the normal range for my age and gender.
Select...
My bilirubin levels are within the normal range for my age.
Select...
My cancer shows a high level of MYCN and I am over 1 year old.
Select...
My kidney function, based on creatinine levels, is within the normal range.
Select...
I am older than 18 months.
Select...
My child's bilirubin level is less than or equal to 0.8 mg/dL.
Select...
I have been diagnosed with neuroblastoma or ganglioneuroblastoma.
Select...
My bilirubin levels are within the required range for my age.
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My condition is newly diagnosed stage 3 neuroblastoma.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 weeks after course 5 of induction
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks after course 5 of induction
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of MIBG Avid Patients Treated With MIBG Labeled With Iodine-131 and Bu/Mel Chemotherapy
Percentage of MIBG Avid Patients Treated With Meta-iodobenxylguanide (MIBG) Labeled With Iodine-131
Secondary outcome measures
Incidence of Unacceptable Toxicity and Sinusoidal Obstruction Syndrome (SOS), Assessed by Common Terminology Criteria (CTV)v.4.0 for Toxicity Assessment and Grading for I-MIBG
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (131I-MIBG, chemotherapy)Experimental Treatment19 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vincristine Sulfate
2005
Completed Phase 3
~10150
Isotretinoin
2019
Completed Phase 4
~3520
Topotecan Hydrochloride
2013
Completed Phase 3
~6120
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Cisplatin
2013
Completed Phase 3
~1940
External Beam Radiation Therapy
2006
Completed Phase 3
~3150
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2160
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~1800
Busulfan
2008
Completed Phase 3
~1120
Cyclophosphamide
1995
Completed Phase 3
~3770
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9870
In Vitro-Treated Peripheral Blood Stem Cell Transplantation
2010
Completed Phase 2
~70
Melphalan
2008
Completed Phase 3
~1500
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7230
Etoposide Phosphate
2011
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,264 Total Patients Enrolled
205 Trials studying Neuroblastoma
53,585 Patients Enrolled for Neuroblastoma
Children's Oncology GroupLead Sponsor
456 Previous Clinical Trials
239,687 Total Patients Enrolled
63 Trials studying Neuroblastoma
31,770 Patients Enrolled for Neuroblastoma
Brian D WeissPrincipal InvestigatorChildren's Oncology Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had high-dose radiation to my kidneys or liver.I am breastfeeding but agree to stop if I join the trial.I am older than 18 months and my cancer has unfavorable pathology.I am over 1 year old with a specific type of stage 2 neuroblastoma.I've had limited treatment for neuroblastoma, following specific protocols.My creatinine level is equal to or less than 1.2 mg/dL, and I am between 10 and 13 years old.My kidney function is within the normal range for my age and gender.My bilirubin levels are within the normal range for my age.My kidney function tests are within normal range for my age and gender.My neuroblastoma is newly diagnosed and classified as stage 4.My cancer shows a specific genetic change and I am over 1 year old.My cancer progressed to stage 4 without chemotherapy after initial diagnosis.My child's bilirubin level is less than or equal to 1.0 mg/dL.My liver enzymes are within normal limits for my age.My child is 1-1.5 years old with specific unfavorable cancer features or unknown cancer features.My cancer shows a high level of MYCN and I am over 1 year old.My kidney function, based on creatinine levels, is within the normal range.I am older than 18 months.My child's bilirubin level is less than or equal to 0.8 mg/dL.I have been diagnosed with neuroblastoma or ganglioneuroblastoma.My child is 12-18 months old with stage 4 neuroblastoma but does not qualify due to favorable factors.My bilirubin levels are within the required range for my age.My condition is newly diagnosed stage 3 neuroblastoma.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (131I-MIBG, chemotherapy)
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.
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