Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
With
Y-mAbs Therapeutics
Age
3–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients with the diagnosis of neuroblastoma must meet both of the following criteria:
* Diagnosis confirmed by histological assessment by MSKCC Department of pathology or by the presence of BM metastases PLUS elevated urinary catecholamines
* Relapsed or refractory stage 4 disease or relapsed or refractory stage MYCN-amplified 2B or 3 disease.
* Patients with tumors other than neuroblastoma must meet both the following criteria:
* Have one of the following diagnoses (these tumors are known to express GD2 on cell surface):
* Melanoma
* Osteogenic sarcoma
* Leiomyosarcoma
* Ewing sarcoma
* Liposarcoma
* Fibrosarcoma
* Malignant fibrous histiocytoma
* Spindle cell sarcoma
* Small cell lung cancer
* Medulloblastoma metastatic to extracranial sites
* Paraganglioma
* Have refractory or relapsed or metastatic disease
* Immunohistochemical demonstration of GD2 expression on cell surface (Tumor assessment by immunohistochemistry is required for this group of patients)
* Have refractory or relapsed disease or metastatic disease. All patients must have measurable or evaluable disease
* Age 3-90 years
* Prior treatment with anti-GD2 monoclonal antibody is permitted only if human anti-human antibody titer is ≤1300 assay developed by Dr. Nai-Kong Cheung.
* Negative serum pregnancy test in women of childbearing potential
* Women of child-bearing potential must be willing to practice an effective method of birth control while on study
* Signed informed consent indicating awareness of the investigational nature of this study.
You may not be if
Existing major organ dysfunction \> grade 2, with the exception of myelosuppression (neutrophil count \> or = 500/μl and platelet count \> or = 25,000/μl are acceptable) and hearing loss.
* Acute life threatening infection
* Requirement for sedation for PET/CT scans
* Pregnant women or women who are breast-feeding.
* Inability to comply with protocol requirements.
* Hypersensitivity to potassium iodide or Lugols products
* Prior development of positive human antimouse antibody response (HAMA) or human antihuman antibody response (HAHA)
* Positive human anti-hu3F8 antibody titer.
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