Back to resultsPET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study
Primary Purpose
Melanoma, Neuroblastoma, Sarcoma
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
124I-Humanized 3F8
Sponsored by
About this trial
This is an interventional diagnostic trial for Melanoma focused on measuring 124I-Humanized 3F8, PET Imaging, 13-147
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET Imaging using 124I-Humanized 3F8
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT02307630
First Posted
November 20, 2014
Last Updated
December 1, 2022
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Y-mAbs Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT02307630
Brief Title
PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study
Official Title
PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 2014 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Y-mAbs Therapeutics
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma, Neuroblastoma, Sarcoma
Keywords
124I-Humanized 3F8, PET Imaging, 13-147
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET Imaging using 124I-Humanized 3F8
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
124I-Humanized 3F8
Primary Outcome Measure Information:
Title
radioactivity measured to determine pharmacokinetics of 124I-hu3F8
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
PET/CT scan images will be analyzed to determine bio distribution of 124I-hu3F8
Description
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
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shakeel Modak, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
PET Imaging of Solid Tumors Using 124I-Humanized 3F8: A Pilot Study
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