NCT02307630Active, not recruiting
PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 7 (actual)
- First submitted
- 20 Nov 2014
- Start date
- Nov 2014
- Primary completion date
- Nov 2026
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Neuroblastoma, Melanoma, Childhood cancers, Sarcoma
- NCT number
- NCT02307630
What you commit to
- Study type: Interventional
- Participants enrolled: 7
- From Nov 2014 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 3 years to 90 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.