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.