Childhood Neuroblastoma, High-risk Neuroblastoma, Neuroblastoma
Conditions
Keywords
High-risk neuroblastoma, neuroblastoma, childhood neuroblastoma, N10, Memorial Sloan Kettering Cancer Center, 24-144
Brief 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.
Interventions
BIOLOGICALDANYELZA
DANYELZA is a humanized monoclonal antibody of the IgG1 subclass
BIOLOGICALSargramostim
Yeast derived recombinant human Sargramostim (GM-CSF)
DRUGCytoxan
Cyclophosphamide is an alkylating agent related to nitrogen mustard
DRUGTopotecan
Topotecan is a topoisomerase I-inhibitor that is a semisynthetic derivative of camptothecin.
DRUGVincristine
Vincristine is an alkaloid isolated from Vinca rosea Linn (periwinkle).
DRUGDoxorubicin
Doxorubicin is an anthracycline antibiotic
DRUGIfosfamide
Ifosfamide is a structural analogue of cyclophosphamide
DRUGEtoposide
Etoposide for Injection is available as a 20 mg/mL solution in sterile multiple dose vials (5 mL, 25 mL, or 50 mL each).
DRUGCarboplatin
Carboplatin is available in 50 mg, 150 mg, 450 mg, and 600 mg vials.
DRUGIrinotecan
Irinotecan hydrochloride trihydrate (CPT-11) is a topoisomerase I inhibitor
DRUGTemozolomide
Temozolomide is administered intravenously
RADIATIONRadiation Therapy
Between first and second cycle of antibody
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Months to 19 Years
Healthy volunteers
No
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 \>/= to grade 3 °Organ dysfunction due to direct effects of primary tumor or metastatic disease, or due to paraneoplastic syndromes associated with neuroblastoma, will not be considered in
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate participant response | After 2 cycles of mAb-based therapy (each cycle is 21 days) | To assess the early Complete Response/CR rate in newly-diagnosed HR-NB patients. |
Countries
United States
Contacts
CONTACTBrian Kushner, MD
CONTACTFiorella Iglasias Cardenas, MD, MS
PRINCIPAL_INVESTIGATORBrian Kushner, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed