PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study

Inclusion criteria

• 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
• Patients with solid tumors with diagnoses OTHER than neuroblastoma or those listed above will be eligible if they meet both of the following criteria:
• 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.

Exclusion criteria

• 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.