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

1 Year
50 Years
Not Enrolling
CNS Cancer, Neuroblastoma, Sarcoma

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Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Shakeel Modak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2001

Completion Date:

May 2009

Related Keywords:

  • CNS Cancer
  • Neuroblastoma
  • Sarcoma
  • Neuroblastoma
  • Central Nervous System Neoplasms
  • Sarcoma



Memorial Sloan-Kettering Cancer CenterNew York, New York  10021