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Trial Title:
N10: a Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children with Neuroblastoma
NCT ID:
NCT06528496
Condition:
High-risk Neuroblastoma
Neuroblastoma
Childhood Neuroblastoma
Conditions: Official terms:
Neuroblastoma
Cyclophosphamide
Temozolomide
Ifosfamide
Carboplatin
Doxorubicin
Irinotecan
Etoposide
Vincristine
Topotecan
Molgramostim
Sargramostim
Conditions: Keywords:
High-risk neuroblastoma
neuroblastoma
childhood neuroblastoma
N10
Memorial Sloan Kettering Cancer Center
24-144
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
DANYELZA
Description:
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
Arm group label:
Participants with Neuroblastoma
Other name:
Naxitamab
Intervention type:
Biological
Intervention name:
Sargramostim
Description:
Yeast derived recombinant human Sargramostim (GM-CSF)
Arm group label:
Participants with Neuroblastoma
Other name:
granulocyte-macrophage colony-stimulating factor
Other name:
GM-CSF
Intervention type:
Drug
Intervention name:
Cytoxan
Description:
Cyclophosphamide is an alkylating agent related to nitrogen mustard
Arm group label:
Participants with Neuroblastoma
Other name:
Cyclophosphamide
Intervention type:
Drug
Intervention name:
Topotecan
Description:
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of
camptothecin.
Arm group label:
Participants with Neuroblastoma
Intervention type:
Drug
Intervention name:
Vincristine
Description:
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
Arm group label:
Participants with Neuroblastoma
Other name:
Oncovin
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Doxorubicin is an anthracycline antibiotic
Arm group label:
Participants with Neuroblastoma
Other name:
Adriamycin
Intervention type:
Drug
Intervention name:
Ifosfamide
Description:
Ifosfamide is a structural analogue of cyclophosphamide
Arm group label:
Participants with Neuroblastoma
Other name:
Isophosphamide
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose
vials (5 mL, 25 mL, or 50 mL each).
Arm group label:
Participants with Neuroblastoma
Other name:
VePesid
Other name:
Etopophos
Other name:
VP-16
Intervention type:
Drug
Intervention name:
Carboplatin
Description:
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
Arm group label:
Participants with Neuroblastoma
Other name:
Paraplatin
Intervention type:
Drug
Intervention name:
Irinotecan
Description:
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
Arm group label:
Participants with Neuroblastoma
Other name:
Camptosar
Intervention type:
Drug
Intervention name:
Temozolomide
Description:
Temozolomide is administered intravenously
Arm group label:
Participants with Neuroblastoma
Other name:
Temodar
Summary:
The purpose of this study is to find out whether N10 chemotherapy is a safe and effective
treatment for children with high-risk neuroblastoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosis of NB as defined by histopathology, BM metastases plus high urine
catecholamine levels, or positivity in MIBG scan.
- HR-NB, defined as MYCN-amplified stage L2/M/MS at any age and stage M in patients
>18 months old.
- No more than one prior cycle of HR-NB chemotherapy
- Age <19 years.
- Signed informed consent indicating awareness of the investigational nature of this
treatment.
Exclusion Criteria:
- Severe dysfunction of major organs, i.e., renal, cardiac, hepatic, neurologic,
pulmonary, hematologic, or gastrointestinal toxicity > grade 2
- Inability to comply with protocol requirements
- Pregnancy
Gender:
All
Minimum age:
18 Months
Maximum age:
19 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Kushner, MD
Phone:
212-639-6793
Start date:
July 22, 2024
Completion date:
July 22, 2029
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06528496
http://www.mskcc.org
