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RM-1929 and Photoimmunotherapy in Recurrent Head and Neck Cancer

Clinical Trial Title: 
A phase I multicenter, open-label, dose-escalation, combination study of RM-1929 And photoimmunotherapy in patients with recurrent HNC who in the opinion of their physician cannot be satisfactorily treated with surgery, radiation or platinum chemotherapy.
Clinical Trial Protocol ID: 
15030601
Clinical Trial Investigator Name: 
Mary Jo Fidler, MD
Clinical Trial Protocol Description: 

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.

Clinical Trial Eligibility Criteria: 

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.

Clinical Trial Area: 
Head and Neck Cancer
Contact Phone: 
(312) 942-5526
Contact Name: 
Pam Sroka BS, BSN, RN, CCRC