Trial Outcomes & Findings for Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery (NCT NCT02855086)
NCT ID: NCT02855086
Last Updated: 2020-03-31
Results Overview
Tumor to background ratios (TBR) will be generated from still images by comparing the relative fluorescence of normal and tumor tissue. The average fluorescence will be compared to the average fluorescence of the surrounding tissue using the paired student's T test for each specimen.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
3 participants
Primary outcome timeframe
1 day
Results posted on
2020-03-31
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)
Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)
Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cetuximab-IRDye 800CW in Detecting Tumors in Patients With Malignant Glioma Undergoing Surgery
Baseline characteristics by cohort
| Measure |
Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)
n=2 Participants
Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)
n=1 Participants
Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayTumor to background ratios (TBR) will be generated from still images by comparing the relative fluorescence of normal and tumor tissue. The average fluorescence will be compared to the average fluorescence of the surrounding tissue using the paired student's T test for each specimen.
Outcome measures
| Measure |
Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)
n=2 Participants
Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)
n=1 Participants
Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Tumor to Background Ratio (TBR)
|
1.39 Fluorescence Tumor to background ratio
Interval 1.2 to 1.58
|
2.65 Fluorescence Tumor to background ratio
Interval 2.65 to 2.65
|
SECONDARY outcome
Timeframe: Up to 30 daysThe incidence of serious and non-serious adverse events is reported as the number of adverse events (Grade 2 or higher), as graded by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Data are reported by number of events by treatment level.
Outcome measures
| Measure |
Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)
n=2 Participants
Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)
n=1 Participants
Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Incidence of Adverse Events
|
0 Adverse events
|
0 Adverse events
|
Adverse Events
Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1 (Cetuximab, Lower Dose Cetuximab-IRDye 800, Surgery)
n=2 participants at risk
Patients receive cetuximab IV over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
Cohort 2 (Cetuximab, Higher Dose Cetuximab-IRDye 800, Surgery)
n=1 participants at risk
Patients receive cetuximab IV over 30 minutes and a higher dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
All patients undergo standard of care surgical resection of tumor on days 2 to 5.
Cetuximab: Given IV
Cetuximab-IRDye 800CW: Given IV
Conventional Surgery: Undergo tumor resection
Laboratory Biomarker Analysis: Correlative studies
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
1/2 • Number of events 1 • 30 days
|
100.0%
1/1 • Number of events 1 • 30 days
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
1/2 • Number of events 1 • 30 days
|
0.00%
0/1 • 30 days
|
|
Investigations
Lymphocyte count decreased
|
50.0%
1/2 • Number of events 1 • 30 days
|
100.0%
1/1 • Number of events 1 • 30 days
|
|
Metabolism and nutrition disorders
Alkalosis
|
50.0%
1/2 • Number of events 1 • 30 days
|
0.00%
0/1 • 30 days
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
50.0%
1/2 • Number of events 1 • 30 days
|
100.0%
1/1 • Number of events 1 • 30 days
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
100.0%
2/2 • Number of events 3 • 30 days
|
100.0%
1/1 • Number of events 1 • 30 days
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
2/2 • Number of events 2 • 30 days
|
0.00%
0/1 • 30 days
|
|
Nervous system disorders
Nervous system disorders - Other, Imbalance
|
50.0%
1/2 • Number of events 1 • 30 days
|
0.00%
0/1 • 30 days
|
|
Vascular disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • 30 days
|
0.00%
0/1 • 30 days
|
Additional Information
Gordon Li, MD, Associate Professor of Neurosurgery
Stanford University Medical Center
Phone: 650-721-1020
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place