RM-1929 and Photoimmunotherapy in Recurrent Head and Neck Cancer
This is a two part study of patients with recurrent head and neck cancer (HNC) who, in the opinion of their physician, cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy. Part I determines the drug dose that can be safely given to saturate the epidermal growth factor receptor (EGFR) at the tumor using the study drug RM-1929. Part II determines the optimal light application, in combination with the Part I drug dose, needed to achieve response with an acceptable safety profile.
In order to participate you must meet the following criteria:
- Have recurrent squamous carcinoma of the head and neck that, in the opinion of the treating physician, cannot be satisfactorily treated with surgery, radiation, or platinum chemotherapy.
- Have a diagnosis confirmed by biopsy and histopathology.
- Have received prior systemic platinum-based chemotherapy for treatment of head and neck cancer unless, in the opinion of the medical oncologist, the use of platinum-based chemotherapy is contraindicated or not recommended (e.g., renal impairment, allergy to platinum compounds, age, liver disease, myelosuppression, neuropathy, hearing loss, etc).
- Have an ECOG score of 0 – 2.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of, or display significant infusion reactions to Erbitux®.
- Are on chemotherapy or Erbitux® therapy or radiation therapy within 4 weeks of enrollment, except for treatment as part of this protocol.
- Have a tumor that is not clearly shown on a CT scan or is clinically measurable.
- Have a tumor invading a major blood vessel (such as the carotid artery).
This is a partial list of inclusion and exclusion criteria.