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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01165 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| BRNCNS0008 | Other Identifier | Stanford Cancer Institute | |
| P30CA124435 | U.S. NIH Grant/Contract | View source | |
| IRB-37595 | Other Identifier | Stanford IRB |
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logistics
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study is a phase 1-2 trial that evaluates the best dose of cetuximab-IRDye 800CW and how well it works in detecting tumors in patients with malignant glioma who are undergoing surgery. Cetuximab-IRDye 800CW is an optical imaging agent that may help detect tumor cells when a special camera is used.
This is a dose-escalation study of cetuximab-IRDye 800CW. Patients are assigned to 1 of 2 cohorts.
COHORT I: Patients receive cetuximab intravenously (IV) over 30 minutes and a lower dose of cetuximab IRDye800 IV over 30 minutes to 1 hour on day 0.
COHORT II: 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 2-5.
After completion of study, patients are followed up at days 10 and 30.
PRIMARY OBJECTIVE:
Determine the efficacy of cetuximab-IRDye 800CW (cetuximab IRDye800) in intraoperatively identifying malignant glioma compared to surrounding normal central nervous system tissue, as measured by tumor-to-background ratio.
SECONDARY OBJECTIVE:
Determine the tolerability of the cetuximab IRDye800 as an imaging agent in subjects undergoing resection of malignant glioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 50 mg cetuximab-IRDye 800 | Experimental | 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. |
|
| 100 mg cetuximab-IRDye 800 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetuximab | Biological | Administered intravenously (IV) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tumor to Background Ratio (TBR) | 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | The 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. | Up to 30 days |
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INCLUSION CRITERIA
EXCLUSION CRITERIA
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| Name | Affiliation | Role |
|---|---|---|
| Gordon Li, MD | Stanford University | Principal Investigator |
| Eben Rosenthal, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Tumor to Background Ratio (TBR) | 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. | Posted | Mean | Full Range | Fluorescence Tumor to background ratio | 1 day |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE 4 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gordon Li, MD, Associate Professor of Neurosurgery | Stanford University Medical Center | 650-721-1020 | gordonli@stanford.edu |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D005910 | Glioma |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000911 | Antibodies, Monoclonal |
| D000094463 | Transurethral Resection of Bladder |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
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| Cetuximab-IRDye 800CW | Drug | Administered intravenously (IV) |
|
|
| Tumor resection | Procedure | Standard of care treatment |
|
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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 |
|
|
| Secondary | Incidence of Adverse Events | The 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. | Posted | Number | Adverse events | Up to 30 days |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| EG001 | 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 | 0 | 1 | 0 | 1 | 1 | 1 |
| Alanine aminotransferase increased | Investigations | CTCAE 4 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | CTCAE 4 | Systematic Assessment |
|
| Alkalosis | Metabolism and nutrition disorders | CTCAE 4 | Systematic Assessment |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE 4 | Systematic Assessment |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE 4 | Systematic Assessment |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE 4 | Systematic Assessment |
|
| Nervous system disorders - Other, Imbalance | Nervous system disorders | CTCAE 4 | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE 4 | Systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |