Trial Outcomes & Findings for Tumor Detection Using Iodine-131-Labeled Monoclonal Antibody 8H9 (NCT NCT00582608)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

2 years

Results posted on

2017-03-01

Participant milestones
Measure	MAB 131-I LABELED 8H9 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 Study STARTED	12
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	12

Reasons for withdrawal
Measure	MAB 131-I LABELED 8H9 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 Study Not Treated	7
Overall Study Patient Ineligible	1
Overall Study Lack of accrual	4

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

Baseline characteristics by cohort
Measure	MAB 131-I LABELED 8H9 n=12 Participants 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.
Age, Categorical <=18 years	5 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Gender Female	5 Participants n=5 Participants
Gender Male	7 Participants n=5 Participants

Timeframe: 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.

Outcome measures
Measure	MAB 131-I LABELED 8H9 n=5 Participants 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.
Safety and Toxicity is Measured by the Total Number of Participants Affected	5 Participants

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events
Measure	MAB 131-I LABELED 8H9 n=5 participants at risk 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.
Metabolism and nutrition disorders Hypokalemia	40.0% 2/5 • Number of events 2
Blood and lymphatic system disorders Lymphopenia	60.0% 3/5 • Number of events 4
Blood and lymphatic system disorders Platelets	20.0% 1/5 • Number of events 1
Blood and lymphatic system disorders Hypophosphatemia	20.0% 1/5 • Number of events 1
Blood and lymphatic system disorders Hemoglobin (Hgb)	20.0% 1/5 • Number of events 1

Other adverse events
Measure	MAB 131-I LABELED 8H9 n=5 participants at risk 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.
Blood and lymphatic system disorders Hemoglobin decreased	80.0% 4/5 • Number of events 4
Blood and lymphatic system disorders Leukocyte count decreased	40.0% 2/5 • Number of events 2
Blood and lymphatic system disorders Neutrophil count decreased	60.0% 3/5 • Number of events 3
Blood and lymphatic system disorders Platelet count decreased	40.0% 2/5 • Number of events 2
Skin and subcutaneous tissue disorders Pruritus	20.0% 1/5 • Number of events 1
Blood and lymphatic system disorders Serum calcium decreased	40.0% 2/5 • Number of events 2

Memorial Sloan Kettering Cancer Center

Phone: 212-639-7623