TheranosticTrials.org

Clinical Trial · NCT00582608

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

Overview

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.

Sponsor

Memorial Sloan Kettering Cancer Center

Phase

N/A

Contacts

Shakeel Modak, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00582608

Eligibility

Inclusion

  • 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.
  • 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.
  • 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

  • Patient's own tumor is negative by 8H9 immunostaining.
  • History of allergy to iodine or mouse proteins.
  • Patients previously treated with mouse monoclonal antibodies are not eligible unless they have no circulating HAMA.
  • Clinically apparent infections.