Phase II Panitumumab-IRDye800 in Head & Neck Cancer
Phase II Panitumumab-IRDye800 in Head & Neck Cancer
The purpose of this study is to determine if panitumumab-IRDye800 is effective in identifying cancer, compared to surrounding normal tissue, and the further characterize the safety profile of this drug.
Head/Neck
Phase II
Adults
Mol. targeted/Immunotherapy/Biologics
Panitumumab-IRDye800
Rosenthal, Eben
National
Vanderbilt University
03-27-2023
Eligibility
18 Years and older
ALL
false
Inclusion Criteria:
1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
2. Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
2. Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
3. Planned standard of care surgery with curative intent for squamous cell carcinoma
3. Planned standard of care surgery with curative intent for squamous cell carcinoma
4. Male or female patients age 18 years
4. Male or female patients age 18 years
5. Have life expectancy of more than 12 weeks
5. Have life expectancy of more than 12 weeks
6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: 1. Hemoglobin 9 gm/dL 2. Absolute Neutrophil Count 1500 3. White Blood Cell count > 3000/mm3 4. Platelet count 100,000/mm3 5. Serum creatinine 1.5 times upper reference range
7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: 1. Hemoglobin 9 gm/dL 2. Absolute Neutrophil Count 1500 3. White Blood Cell count > 3000/mm3 4. Platelet count 100,000/mm3 5. Serum creatinine 1.5 times upper reference range
Exclusion Criteria:
1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
3. History of infusion reactions to any monoclonal antibody therapies
3. History of infusion reactions to any monoclonal antibody therapies
4. Women who are pregnant or breast-feeding
4. Women who are pregnant or breast-feeding
5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
6. Magnesium or potassium lower than the normal institutional values
6. Magnesium or potassium lower than the normal institutional values
7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
9. TSH > 13 micro International Units/mL
9. TSH > 13 micro International Units/mL
1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
1. Biopsy confirmed diagnosis of squamous cell carcinoma of the head and neck
2. Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
2. Diagnosis of any T stage, any subsite within the head and neck that are scheduled to undergo surgical resection. Patients with recurrent disease or a new primary will be allowed.
3. Planned standard of care surgery with curative intent for squamous cell carcinoma
3. Planned standard of care surgery with curative intent for squamous cell carcinoma
4. Male or female patients age 18 years
4. Male or female patients age 18 years
5. Have life expectancy of more than 12 weeks
5. Have life expectancy of more than 12 weeks
6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
6. Karnofsky performance status of at least 70% or ECOG/Zubrod level 1
7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: 1. Hemoglobin 9 gm/dL 2. Absolute Neutrophil Count 1500 3. White Blood Cell count > 3000/mm3 4. Platelet count 100,000/mm3 5. Serum creatinine 1.5 times upper reference range
7. Have acceptable hematologic status, coagulation status, kidney function, and liver function including the following clinical results: 1. Hemoglobin 9 gm/dL 2. Absolute Neutrophil Count 1500 3. White Blood Cell count > 3000/mm3 4. Platelet count 100,000/mm3 5. Serum creatinine 1.5 times upper reference range
Exclusion Criteria:
1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
1. Received an investigational drug within 30 days prior to first dose of panitumumab-IRDye800
2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
2. Had within 6 months prior to enrollment: MI, CVA, or uncontrolled CHF
3. History of infusion reactions to any monoclonal antibody therapies
3. History of infusion reactions to any monoclonal antibody therapies
4. Women who are pregnant or breast-feeding
4. Women who are pregnant or breast-feeding
5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
5. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females)
6. Magnesium or potassium lower than the normal institutional values
6. Magnesium or potassium lower than the normal institutional values
7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
7. Patients receiving Class IA (quinidine, procanamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
8. Patients with a history or evidence of interstitial pneumonitis or pulmonary fibrosis
9. TSH > 13 micro International Units/mL
9. TSH > 13 micro International Units/mL
