penile cancer
Conditions
Interventions
After written informed consent is obtained, patients will receive an
intravenous administration of 75mg *cold* cetuximab followed by 15mg of
cetuximab-800CW 1 hour after the administration of the pr
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Biopsy confirmed diagnosis of primary or recurrent PSCC and scheduled to undergo surgical resection of primary or recurrent tumor with or without (sentinel) lymph node procedure as decided by the Urology Department of the UMCG. 2. Age >= 18 years 3. Written informed consent 4. Adequate potential for follow-up
Exclusion criteria
Exclusion criteria: 1. Medical or psychiatric conditions that compromise the patient*s ability to give informed consent 2. Concurrent uncontrolled medical conditions 3. Received an investigational drug within 30 days prior to the dose of cetuximab-800CW 4. Tumors at sites of which the surgeon would assess that in vivo imaging would not be feasible 5. Had within 6 months prior to enrollment: myocardial infarction, cerebrovascular accident, uncontrolled cardiac heart failure, significant liver disease, unstable angina 6. Inadequately controlled hypertension with or without current antihypertensive medications 7. History of infusion reactions to cetuximab or other monoclonal antibody therapies 8. Evidence of QT prolongation on pretreatment ECG (greater than 440 ms in males or greater than 450 ms in females) 9. Lab values that in the opinion of the primary surgeon would prevent surgical resection 10. Patients receiving Class Ia (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents 11. Magnesium, potassium and calcium deviations that might lead to cardiac rhythm (grade II or higher deviations by CTCAE) 12. Life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of this feasibility study is to investigate whether cetuximab-800CW could be used for margin assessment during surgery in patients with PSCC. | — |
Countries
Netherlands
Outcome results
None listed