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

NCT ID: NCT00582608

Last Updated: 2017-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2009-05-31

Brief 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.

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.

Conditions

CNS Cancer; Neuroblastoma; Sarcoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

131I-8H9 and 8H9

This is an open-label single arm study of 131 I-8H9. injected intravenously at 10mCi/1.73m\^2 dose \[intended specific activity of '20mCi/mg protein\] preceded by administration of 50mg/1.73m2 of unlabeled -8H9.

Group Type: EXPERIMENTAL

131I-8H9

Intervention Type: DRUG

This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m\^2 dose \[intended specific activity of \~20 mCi/mg protein\]

8H9

Intervention Type: DRUG

administration of 50mg/1.73m\^2 of unlabeled 8H9.

Interventions

131I-8H9

This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m\^2 dose \[intended specific activity of \~20 mCi/mg protein\]

Intervention Type: DRUG

8H9

administration of 50mg/1.73m\^2 of unlabeled 8H9.

Intervention Type: DRUG

Eligibility 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. 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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shakeel Modak, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Countries

United States

Related Links

http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

00-066

Identifier Type: -

Identifier Source: org_study_id