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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00582608
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Duration (Months): 91
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CNS Cancer; Neuroblastoma; Sarcoma	Drug: 131I-8H9; Drug: 8H9	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9
• Study Start Date: Oct 1, 2001
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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]; Drug: 8H9; administration of 50mg/1.73m^2 of unlabeled 8H9.

Outcome Measures

Primary Outcome Measures

1. Safety and Toxicity is Measured by the Total Number of Participants Affected [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Shakeel Modak, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Memorial Sloan Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT00582608
• Other Study ID Numbers: 00-066
• First Posted: Dec 28, 2007
• Last Update Posted: Mar 1, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Neuroblastoma; N-(2-aminoethyl)-5-isoquinolinesulfonamide

Study Results

Participant Flow

Arm/Group Title	MAB 131-I LABELED 8H9
Arm/Group Description	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.
Period Title: Overall Study
STARTED	12
COMPLETED	0
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	MAB 131-I LABELED 8H9
Arm/Group Description	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.
Overall Participants	12
Age (Count of Participants)
<=18 years	5 41.7%
Between 18 and 65 years	7 58.3%
>=65 years	0 0%
Gender (Count of Participants)
Female	5 41.7%
Male	7 58.3%

Outcome Measures

1. Primary Outcome

Title	Safety and Toxicity is Measured by the Total Number of Participants Affected
Description	Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	MAB 131-I LABELED 8H9
Arm/Group Description	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.
Measure Participants	5
Count of Participants [Participants]	5 41.7%

Adverse Events

Arm/Group Title	MAB 131-I LABELED 8H9
Arm/Group Description	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.
All Cause Mortality
	MAB 131-I LABELED 8H9
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	MAB 131-I LABELED 8H9
	Affected / at Risk (%)	# Events
Total	4/5 (80%)
Blood and lymphatic system disorders
Lymphopenia	3/5 (60%)	4
Platelets	1/5 (20%)	1
Hypophosphatemia	1/5 (20%)	1
Hemoglobin (Hgb)	1/5 (20%)	1
Metabolism and nutrition disorders
Hypokalemia	2/5 (40%)	2
Other (Not Including Serious) Adverse Events
	MAB 131-I LABELED 8H9
	Affected / at Risk (%)	# Events
Total	5/5 (100%)
Blood and lymphatic system disorders
Hemoglobin decreased	4/5 (80%)	4
Leukocyte count decreased	2/5 (40%)	2
Neutrophil count decreased	3/5 (60%)	3
Platelet count decreased	2/5 (40%)	2
Serum calcium decreased	2/5 (40%)	2
Skin and subcutaneous tissue disorders
Pruritus	1/5 (20%)	1

Limitations/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.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.