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

NCT00582608 | Terminated Results

• 1 other identifier: 00-066
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

CNS Cancer; Neuroblastoma; Sarcoma

Outcome Measures

Primary Outcomes (1)

• Safety and Toxicity is Measured by the Total Number of Participants Affected

  Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol.

  2 years

Study Arms (1)

131I-8H9 and 8H9

EXPERIMENTAL

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.

Drug: 131I-8H9; Drug: 8H9

Interventions

131I-8H9 DRUG

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

131I-8H9 and 8H9

8H9 DRUG

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

131I-8H9 and 8H9

Eligibility Criteria

• Age: 1 Year - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Central Nervous System Neoplasms; Neuroblastoma; Sarcoma

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms, Connective and Soft Tissue

Limitations and Caveats

Technical problems led to unreliable and uninterpretable data. Therefore, there is no data to report under Outcome Measures. Due to lack of patients accrual.

Results Point of Contact

• Title: Dr. Shakeel Modak
• Organization: Memorial Sloan Kettering Cancer Center

modaks@mskcc.org

212-639-7623

Study Officials

• Shakeel Modak, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: December 28, 2007
• Study Start: October 1, 2001
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: March 1, 2017
• Results First Posted: March 1, 2017

Record last verified: 2017-01

Locations

US (1)