Trial Outcomes & Findings for Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer (NCT NCT00006099)
NCT ID: NCT00006099
Last Updated: 2023-10-04
Results Overview
All toxicities were to be graded according to the Common Toxicity Criteria (CTC) Scale, version 2.0, March 1998.The study was to be terminated upon the occurrence of an adverse event of Grade 3 or greater severity that is considered definitely related to hu3S193.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
1 participants
Primary outcome timeframe
up to 30 days
Results posted on
2023-10-04
Participant Flow
Participant milestones
| Measure |
Intraperitoneal (IP) Infusion of 111In-hu3S193
Hu3S193 was administered intraperitoneally (IP) at a dose of 5 mg radiolabeled with 5 millicurie (mCi) of 111In.
Patients received 10 mCi 99mTc-sulphur colloid IP administered in 500 ml of normal saline to assure the absence of any loculation or heterogeneous distribution of radioactivity in the peritoneal cavity. A paracentesis catheter was inserted and the hu3S193 was diluted in 100 mL of 5% human serum albumin and administered as a continuous intraperitoneal infusion over 30 minutes. This was followed immediately by 900 mL of normal saline.
|
Intravenous Infusion of 111In-hu3S193
Hu3S193 was to be administered intravenously at a dose of 5 mg radiolabeled with 5 millicurie (mCi) of 111In, diluted in 100 mL of 5% human serum albumin and administered over a 30 minute period.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Monoclonal Antibody Therapy in Treating Patients Scheduled for Surgery to Remove Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Intraperitoneal (IP) Infusion of 111In-hu3S193
n=1 Participants
Hu3S193 was administered intraperitoneally at a dose of 5 mg radiolabeled with 5 mCi of 111In.
Patients received 10 mCi 99mTc-sulphur colloid IP administered in 500 ml of normal saline to assure the absence of any loculation or heterogeneous distribution of radioactivity in the peritoneal cavity. A paracentesis catheter was inserted and the hu3S193 was diluted in 100 mL of 5% human serum albumin and administered as a continuous intraperitoneal infusion over 30 minutes. This was followed immediately by 900 mL of normal saline.
|
Intravenous Infusion of 111In-hu3S193
Hu3S193 was to be administered intravenously at a dose of 5 mg radiolabeled with 5 mCi of 111In, diluted in 100 mL of 5% human serum albumin and administered over a 30 minute period.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 30 daysPopulation: The 1 patient who entered the study.
All toxicities were to be graded according to the Common Toxicity Criteria (CTC) Scale, version 2.0, March 1998.The study was to be terminated upon the occurrence of an adverse event of Grade 3 or greater severity that is considered definitely related to hu3S193.
Outcome measures
| Measure |
Intraperitoneal (IP) Infusion of 111In-hu3S193
n=1 Participants
Hu3S193 was administered intraperitoneally at a dose of 5 mg radiolabeled with 5 mCi of 111In.
Patients received 10 mCi 99mTc-sulphur colloid IP administered in 500 ml of normal saline to assure the absence of any loculation or heterogeneous distribution of radioactivity in the peritoneal cavity. A paracentesis catheter was inserted and the hu3S193 was diluted in 100 mL of 5% human serum albumin and administered as a continuous intraperitoneal infusion over 30 minutes. This was followed immediately by 900 mL of normal saline.
|
Intravenous Infusion of 111In-hu3S193
Hu3S193 was to be administered intravenously at a dose of 5 mg radiolabeled with 5 mCi of 111In, diluted in 100 mL of 5% human serum albumin and administered over a 30 minute period.
|
|---|---|---|
|
Number of Subjects With Grade 3 Adverse Events
|
0 Participants
|
—
|
Adverse Events
Intraperitoneal (IP) Infusion of 111In-hu3S193
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intravenous Infusion of 111In-hu3S193
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jonathan Skipper PhD
Ludwig Institute for Cancer Research
Phone: 12124501539
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place