- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00582608
Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9
January 10, 2017 updated by: Memorial Sloan Kettering Cancer Center
The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in finding tumors in your body.
Antibodies are protein found naturally in blood.
They can fasten themselves to bacteria and viruses.
They can stimulate white cells and blood proteins to kill tumors.
The antibody 8H9 was made from mouse white cells.
The white cells that secrete this antibody have been made to live for ever.
They manufacture large amounts of 8H9 for patient use.
Although other monoclonal antibodies have been safely tested in people, the antibody 8H9 has never been given to a human patient.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
To test if intravenous injections of iodine-131 labeled murine monoclonal antibody 8H9 can detect primary and metastatic solid tumors.
A total of 60 patients will be accrued over a period of 2 years.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosis of pediatric/adolescent solid tumor (including neuroblastoma, rhabdomyosarcoma, Ewing's/PNET, osteosarcoma, brain tumors, desmoplastic small round cell tumor (DSRT) and other tumors that are 8H9-positive) confirmed by the MSKCC Department of Pathology.
- Patient must have either recurrent disease or have <20% chance of long term disease-free survival.
- Patient must be at least 1 year old. Age can range from 1-50 years of age.
- Patients should have measurable or evaluable disease. For tumor types that are known to be 8H9-positive, patients can be imaged after the diagnosis is made, prior to definitive surgery or surgery to confirm tumor recurrence.
- Tumor tissue is or will be available for 8H9 immunostaining. For patients with tumor-types known to be 8H9-positive, surgical samples obtained after 131I- 8H9 imaging will be immunostained to confirm 8H9-reactivity. These tumor types include: neuroblastoma, rhabdomyosarcoma, osteosarcoma, DSRT, Ewing's Sarcoma/PNET), brain tumors (glioblastoma multiforme, mixed glioma, astrocytoma, ependymoma, medulloblastoma, schwannoma., meningioma).
- If frozen tumor tissue is unavailable, and if bone marrow involvement is demonstrated by histology, 8H9 immunostaining by immunofluorescence will be carried out on patient's bone marrow. In this case, patients will be eligible for study if bone marrow 8H9 immunostaining is positive.
Exclusion Criteria:
- Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal, and neurologic system toxicity should all be less than grade 2. Patients with stable neurological deficits (because of their brain tumor) are not excluded. Patients with <= 3 hearing loss are not excluded.
- Clinically apparent infections.
- History of allergy to iodine or mouse proteins.
- Patients previously treated with mouse monoclonal antibodies are not eligible unless they have no circulating HAMA.
- Pregnant women are excluded for fear of danger to the fetus. Therefore negative pregnancy test is required for all women of child-bearing age, and appropriate contraception is used during the study period.
- Patient's own tumor is negative by 8H9 immunostaining.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 131I-8H9 and 8H9
This is an open-label single arm study of 131 I-8H9.
injected intravenously at 10mCi/1.73m^2 dose [intended specific activity of '20mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled -8H9.
|
This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73
m^2 dose [intended specific activity of ~20 mCi/mg protein]
administration of 50mg/1.73m^2 of unlabeled 8H9.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and Toxicity is Measured by the Total Number of Participants Affected
Time Frame: 2 years
|
Safety and toxicity is measured by the total number of participants affected.
Please see the adverse event table for the specifics for this protocol.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2001
Primary Completion (Actual)
May 1, 2009
Study Completion (Actual)
May 1, 2009
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
December 28, 2007
Study Record Updates
Last Update Posted (Actual)
March 1, 2017
Last Update Submitted That Met QC Criteria
January 10, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroectodermal Tumors, Primitive
- Neuroectodermal Tumors, Primitive, Peripheral
- Neuroblastoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- N-(2-aminoethyl)-5-isoquinolinesulfonamide
Other Study ID Numbers
- 00-066
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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