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

Melanoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02307630
• Other study ID #: 13-147
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2014
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma
• Neuroblastoma
• Sarcoma

Intervention

Biological:
• 124I-Humanized 3F8

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Y-mAbs Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	radioactivity measured to determine pharmacokinetics of 124I-hu3F8	Following 124I-hu3F8 administration, upon completion of normal saline flush, blood will be drawn for pharmacokinetic studies at the following time points: 0h, 0.5h, 1h, 2h, 4-8h, 24h, 48h, 96h and 120-144 h.after injection of 124I-hu3F8 and radioactivity measured to determine pharmacokinetics of 124I-hu3F8.	2 years
Secondary	PET/CT scan images will be analyzed to determine bio distribution of 124I-hu3F8	124I-hu3F8 will be injected IV followed by PET/CT scans at serial timepoints PET/CT scan images will be analyzed to determine biodistribution of 124I-hu3F8	2 years

External Links

•   Memorial Sloan Kettering Cancer Center