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

Sarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00582608
• Other study ID #: 00-066
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: June 4, 2009
• Start date: October 2001
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• CNS Cancer
• Neuroblastoma
• Sarcoma

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		2 years	No
Secondary	Estimate the radiation dose per mCi of 131-I-8H9 delivered to blood, and the relative uptake of tumors versus normal organs in patients.		2 years	No

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