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

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

NCT ID: NCT02307630

Condition: Melanoma
Neuroblastoma
Sarcoma

Conditions: Official terms:
Neuroblastoma

Conditions: Keywords:
124I-Humanized 3F8
PET Imaging
13-147

Study type: Interventional

Study phase: N/A

Overall status: Active, not recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: 124I-Humanized 3F8
Arm group label: PET Imaging using 124I-Humanized 3F8

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:
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.

Gender: All

Minimum age: 3 Years

Maximum age: 90 Years

Healthy volunteers: No

Locations:

Facility:
Name: Memorial Sloan Kettering Cancer Center

Address:
City: New York
Zip: 10065
Country: United States

Start date: November 2014

Completion date: November 2024

Lead sponsor:
Agency: Memorial Sloan Kettering Cancer Center
Agency class: Other

Collaborator:
Agency: Y-mAbs Therapeutics
Agency class: Industry

Source: Memorial Sloan Kettering Cancer Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT02307630
http://www.mskcc.org/