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

NCT02307630 | Active Not Recruiting

• 1 other identifier: 13-147
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sarcoma; Melanoma; Neuroblastoma

Keywords

124I-Humanized 3F8; PET Imaging; 13-147

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• PET/CT scan images will be analyzed to determine bio distribution of 124I-hu3F8

  2 years

Study Arms (1)

PET Imaging using 124I-Humanized 3F8

EXPERIMENTAL

124I-hu3F8 at a dose of 3mCi/m2 (with a maximum dose of 5mCi) will be injected IV. 124I-hu3F8 PET/CT scans will be performed at approximately 2-4 hours, 18-26hours, 48-72 hours and 96-144 hours after injection of 124I-hu3F8. A low dose CT scan will be obtained with each PET scans. PET/CT scan images will be analyzed to determine biodistribution of 124I-hu3F8 and to determine dosimetry to organs and sites of disease. Comparison of tumor targeting and tumor dosimetry will be made between the two cohorts of patients: (a) NB and (b) other solid tumors. Blood will be drawn where feasible at multiple time points: approximately 0h, 0.5h, 1h, 2h, 4-8h, 24h, 48h, 96h and 120h-144h after injection of 124I-hu3F8 and radioactivity measured to determine pharmacokinetics of 124I-hu3F8.

Biological: 124I-Humanized 3F8

Interventions

124I-Humanized 3F8 BIOLOGICAL

PET Imaging using 124I-Humanized 3F8

Eligibility Criteria

• Age: 3 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Y-mAbs Therapeutics: collaborator
• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Melanoma; Neuroblastoma; Sarcoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neoplasms, Glandular and Epithelial; Neoplasms, Connective and Soft Tissue

Study Officials

• Shakeel Modak, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-12

Locations

US (1)