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Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9

This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, June 2008

Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00582608
  Purpose

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.


Condition Intervention
CNS Cancer
Neuroblastoma
Sarcoma
Drug: MAB 131-I LABELED 8H9

MedlinePlus related topics:   Cancer    Neuroblastoma    Soft Tissue Sarcoma   

Drug Information available for:   Iodine    Cadexomer iodine    Sodium iodide I 131   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Diagnostic, Non-Randomized, Open Label, Single Group Assignment
Official Title:   Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Define the level of agreement between 131-I-8H9 and conventional imaging modalities in the detection of primary and metastatic 8H9-positive solid tumors in pediatrics. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimate the radiation dose per mCi of 131-I-8H9 delivered to blood, and the relative uptake of tumors versus normal organs in patients. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:   60
Study Start Date:   October 2001
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental Drug: MAB 131-I LABELED 8H9
This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose [intended specific activity of ~20 mCi/mg protein] preceded by administration of 50mg/1.73m2 of unlabeled 8H9.

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.

  Eligibility
Ages Eligible for Study:   1 Year to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 (Appendix B). 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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00582608

Contacts
Contact: Shakeel Modak, MD     modaks@mskcc.org    

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center     Recruiting
      New York, New York, United States, 10065

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Investigators
Principal Investigator:     Shakeel Modak, MD     Memorial Sloan-Kettering Cancer Center    
  More Information


Related Info  This link exits the ClinicalTrials.gov site
 

Responsible Party:   Memorial Sloan-Kettering Cancer Center ( Shakeel Modak, MD )
Study ID Numbers:   00-066
First Received:   December 21, 2007
Last Updated:   June 2, 2008
ClinicalTrials.gov Identifier:   NCT00582608
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Malignant mesenchymal tumor
Central Nervous System Neoplasms
Neuroblastoma
Soft tissue sarcomas
Antibodies, Monoclonal
Neuroectodermal Tumors
Antibodies
Neoplasms, Germ Cell and Embryonal
Sarcoma
Neuroepithelioma
Iodine
Neuroectodermal Tumors, Primitive, Peripheral
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008




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