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PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study
Conditions
Melanoma - Neuroblastoma - Sarcoma
Conditions: official terms
Neuroblastoma
Conditions: Keywords
124I-Humanized 3F8, PET Imaging, 13-147
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: 124I-Humanized 3F8
Type: Biological
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 3 Years
Gender: Both
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.
- 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.
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Shakeel Modak, MD - 212-639-7623
Start Date
November 2014
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page