Back to resultsTumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9
Primary Purpose
CNS Cancer, Neuroblastoma, Sarcoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
131I-8H9
8H9
Sponsored by
About this trial
This is an interventional diagnostic trial for CNS Cancer
Eligibility Criteria
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
131I-8H9 and 8H9
Arm Description
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.
Outcomes
Primary Outcome Measures
Safety and Toxicity is Measured by the Total Number of Participants Affected
Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol.
Secondary Outcome Measures
Full Information
NCT ID
NCT00582608
First Posted
December 21, 2007
Last Updated
January 10, 2017
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT00582608
Brief Title
Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9
Official Title
Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Lack of accrual
Study Start Date
October 2001 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CNS Cancer, Neuroblastoma, Sarcoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
131I-8H9 and 8H9
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
131I-8H9
Intervention Description
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]
Intervention Type
Drug
Intervention Name(s)
8H9
Intervention Description
administration of 50mg/1.73m^2 of unlabeled 8H9.
Primary Outcome Measure Information:
Title
Safety and Toxicity is Measured by the Total Number of Participants Affected
Description
Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9
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