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.
| Condition(s) | Head and Neck Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 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. 3. Planned standard of care surgery with curative intent for squamous cell carcinoma 4. Male or female patients age ≥ 18 years 5. Have life expectancy of more than 12 weeks 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of Alabama at Birmingham |
| Locations | Birmingham, Alabama, United States |
| Start date | 2021-04-02 |
| NCT ID | NCT04511078 |
| Official listing | https://clinicaltrials.gov/study/NCT04511078 |