Melanoma Clinical Trial

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

Summary

The purpose of this study is to find out how an antibody called Hu3F8 travels through the body and to tumors. Antibodies, like Hu3F8, are proteins that help attack tumors or fight infections. Antibodies can be made by your own body or in a laboratory. The target of an antibody is called an antigen; antibodies fit their antigen like a lock fits a key.

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Eligibility Criteria

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.

Study is for people with:

Melanoma

Estimated Enrollment:

7

Study ID:

NCT02307630

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States

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Study is for people with:

Melanoma

Estimated Enrollment:

7

Study ID:

NCT02307630

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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