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Chemotherapy

MIBG + Chemotherapy for Neuroblastoma

Phase 1
Waitlist Available
Led By Brian Weiss, MD
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
Must not have
Female patients who are lactating must agree to stop breast-feeding
Patients that are 12-18 months of age with INSS stage 4 and all 3 favorable biologic features (i.e., non-amplified MYCN, favorable pathology, and DNA index > 1) are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 weeks after course 5 of induction
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.
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My child's bilirubin level is less than or equal to 1.0 mg/dL.
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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.
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My bilirubin levels are within the normal range for my age.
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My cancer shows a high level of MYCN and I am over 1 year old.
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My kidney function, based on creatinine levels, is within the normal range.
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I am older than 18 months.
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My child's bilirubin level is less than or equal to 0.8 mg/dL.
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I have been diagnosed with neuroblastoma or ganglioneuroblastoma.
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My bilirubin levels are within the required range for my age.
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My condition is newly diagnosed stage 3 neuroblastoma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am breastfeeding but agree to stop if I join the trial.
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My child is 12-18 months old with stage 4 neuroblastoma but does not qualify due to favorable factors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 weeks after course 5 of induction
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 weeks after course 5 of induction 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 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 study objectives
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

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: Treatment (131I-MIBG, chemotherapy)Experimental Treatment19 Interventions
See Detailed Description.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intensity-Modulated Radiation Therapy
2010
Completed Phase 3
~2140
External Beam Radiation Therapy
2006
Completed Phase 3
~3300
Topotecan Hydrochloride
2013
Completed Phase 3
~6270
Vincristine Sulfate
2005
Completed Phase 3
~10270
Busulfan
2008
Completed Phase 4
~1710
Cisplatin
2013
Completed Phase 3
~3120
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
In Vitro-Treated Peripheral Blood Stem Cell Transplantation
2010
Completed Phase 2
~70
Isotretinoin
2019
Completed Phase 4
~3520
Melphalan
2008
Completed Phase 3
~1500
Etoposide Phosphate
2011
Completed Phase 2
~160
Therapeutic Conventional Surgery
2005
Completed Phase 3
~9890
3-Dimensional Conformal Radiation Therapy
2010
Completed Phase 3
~7490
Autologous Hematopoietic Stem Cell Transplantation
2017
Completed Phase 3
~2090
Cyclophosphamide
2010
Completed Phase 4
~2310

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,934 Previous Clinical Trials
41,022,234 Total Patients Enrolled
11 Trials studying Ganglioneuroblastoma
12,255 Patients Enrolled for Ganglioneuroblastoma
Children's Oncology GroupLead Sponsor
460 Previous Clinical Trials
239,899 Total Patients Enrolled
5 Trials studying Ganglioneuroblastoma
11,536 Patients Enrolled for Ganglioneuroblastoma
Brian Weiss, MDPrincipal InvestigatorChildren's Oncology Group
2 Previous Clinical Trials
58 Total Patients Enrolled

Media Library

Busulfan (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT01175356 — Phase 1
Ganglioneuroblastoma Research Study Groups: Treatment (131I-MIBG, chemotherapy)
Ganglioneuroblastoma Clinical Trial 2023: Busulfan Highlights & Side Effects. Trial Name: NCT01175356 — Phase 1
Busulfan (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01175356 — Phase 1
~7 spots leftby Dec 2025
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