Not provided
Not provided
Not provided
Not provided
Not provided
Study terminated due to business priorities
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-arm, uncontrolled, international, multi-center, clinical,phase 2 trial, in patients ≥ 12 months of age with high-risk neuroblastoma in first remission. 120 patients will be enrolled to receive naxitamab + GM-CSF in combination with isotretinoin.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| naxitamab + GM-CSF + isotretinoin | Experimental | 8 cycles. Cycles 1+2 naxitamab + GM-CSF, cycles 3-5 naxitamab + GM-CSF + isotretinoin, cycles 6-8 isotretinoin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naxitamab | Drug | 3.0 mg/kg/day = 9.0 mg/kg/cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year progression free survival (PFS) | 2-year PFS defined as the proportion of patients alive and without progressive disease (PD) or relapse 2 years after enrollment | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival (defined as time from enrollment until progressive disease/relapse or death, whichever comes first) | 128 weeks |
| 1-year progression free survival |
Not provided
Inclusion Criteria:
Documentet neuroblastoma at time of diagnosis defined as
Documented high-risk disease at time of initial diagnosis defined as
Patient must have completed frontline therapy, and achieved one of the following:
Age ≥ 12 months at trial enrollment
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hong Kong Children's Hospital | Kowloon | Hong Kong | ||||
| National Medical Research Center Pediatric Hematology, Oncology and Immunology n.a Dmitry Rogachev |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| GM-CSF |
| Drug |
250 - 500 microgram/m2/day |
|
| Isotretinoin | Drug | 160 mg/m2/day |
|
1-year progression free survival defined as the proportion of patients alive and without progressive disease or relapse 1 year after enrollment
| 1 year |
| 1-year and 2-year overall survival | 1-year and 2-year overall survival defined as the proportion of patients alive 1 year and 2 years after enrollment, respectively | 2 years |
| 2-year event-free survival | 2-year event-free survival, defined as the proportion of patients alive and without progressive disease, relapse, secondary malignancy or until last contact if no event occurred, 2 years after enrollment | 2 years |
| Proportion of positive to negative minimal residual disease (MRD) after 2 cycles | Proportion of patients changing from minimal residual disease positive in bone marrow at enrollment (defined as patients assessed as minimal residual disease positive by RTqPCR of bone marrow at enrollment) to minimal residual disease negative at completion of Cycle 2 | 6 weeks |
| Proportion of patients with MD positive convert to MRD negative | Proportion of patients with disease in bone marrow at enrollment (i.e., minimal disease according to INRC) and convert to minimal residual disease negative (assessed by RTqPCR) at completion of Cycle 2 | 6 weeks |
| Moscow |
| Russia |
| Research Institute of Pediatric Oncology ad Hematology of N.N. Blokhin National Medical Research Center of Oncology | Moscow | Russia |
| Raisa Gorbacheva Memorial Institute of Children Hematology and Transplantation Bone marrow Transplant Clinic | Saint Petersburg | Russia |
| ICON Cancer Centre Novena | Singapore | Singapore |
| KK Women's and Children's Hospital | Singapore | Singapore |
| Asan Medical Center Childrens Hospital | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Soeul | South Korea |
| ID | Term |
|---|---|
| D009447 | Neuroblastoma |
| ID | Term |
|---|---|
| D018241 | Neuroectodermal Tumors, Primitive, Peripheral |
| D018242 | Neuroectodermal Tumors, Primitive |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C000718263 | naxitamab |
| D016178 | Granulocyte-Macrophage Colony-Stimulating Factor |
| D015474 | Isotretinoin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D012176 | Retinoids |
| D002338 | Carotenoids |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D013729 | Terpenes |
| D010860 | Pigments, Biological |
Not provided
Not provided