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Monoclonal Antibodies

Reduced Chemotherapy and Monoclonal Antibody Therapy for Neuroblastoma

Phase 2
Recruiting
Led By Brian Kushner, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of NB as defined by histopathology, BM metastases plus high urine catecholamine levels, or positivity in MIBG scan
No more than one prior cycle of HR-NB chemotherapy
Must not have
Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic, pulmonary, hematologic, or gastrointestinal toxicity greater than grade 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 2 cycles of mab-based therapy (each cycle is 21 days)
Awards & highlights

Summary

"This trial aims to determine if N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma."

Who is the study for?
This trial is for children with high-risk neuroblastoma. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may need parental consent.
What is being tested?
The study tests N10 chemotherapy's safety and effectiveness in treating high-risk neuroblastoma in children. It involves a combination of drugs: DANYELZA, Sargramostim, Carboplatin, Irinotecan, Temozolomide, Topotecan, Doxorubicin, Cytoxan (Cyclophosphamide), Ifosfamide, Vincristine and Etoposide.
What are the potential side effects?
Potential side effects could include nausea/vomiting; hair loss; fatigue; increased risk of infections due to low blood cell counts; organ damage; allergic reactions to monoclonal antibodies like DANYELZA.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with neuroblastoma based on tests.
Select...
I have had only one round of HR-NB chemotherapy.
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My cancer is a specific type of neuroblastoma with certain genetic features.
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I am under 19 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have severe problems with my kidneys, heart, liver, brain, lungs, blood, or stomach.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 2 cycles of mab-based therapy (each cycle is 21 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 2 cycles of mab-based therapy (each cycle is 21 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluate participant response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Participants with NeuroblastomaExperimental Treatment11 Interventions
Participants will receive 4 cycles of induction chemotherapy followed by a response-based intervention.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
2006
Completed Phase 4
~880
Etoposide
2010
Completed Phase 3
~2960
Cytoxan
2007
Completed Phase 3
~1460
Vincristine
2003
Completed Phase 4
~2970
Carboplatin
2014
Completed Phase 3
~6120
Topotecan
2017
Completed Phase 3
~2460
Ifosfamide
2010
Completed Phase 4
~3140
Doxorubicin
2012
Completed Phase 3
~8030
Temozolomide
2010
Completed Phase 3
~1880
Irinotecan
2017
Completed Phase 3
~2580

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,511 Total Patients Enrolled
50 Trials studying Neuroblastoma
5,791 Patients Enrolled for Neuroblastoma
Brian Kushner, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
11 Previous Clinical Trials
1,137 Total Patients Enrolled
11 Trials studying Neuroblastoma
1,137 Patients Enrolled for Neuroblastoma
~30 spots leftby Jul 2029
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