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.
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.
- 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
- 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.
- 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.