Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Luzitin SA

Criteria

Inclusion Criteria:

• Written informed consent

• Men or non-pregnant, non-breast feeding women

• Karnofsky performance status of 60% or greater

• Histologically confirmed recurrent/refractory squamous cell carcinoma of the head and neck

• Clearly visible tumor on the oral cavity or cutaneous surface

Exclusion Criteria:

• Known hypersensitivity to any of the formulation ingredients

• Known hypersensitivity to porphyrins

• Porphyria or other diseases exacerbated by light

• Tumors known to be eroding into a major blood vessel in or adjacent to the irradiation site

• Planned skin phototherapy session(s) within the study timeframe

• Planned surgical procedure within the study timeframe

• Coexisting ophthalmic disease likely to require slit-lamp examination within the study timeframe

• Existing therapy with a photosensitizing agent

• Unstable angina and/or congestive heart failure requiring hospitalization within 6 months prior to screening

• Myocardial infarction within 6 months prior to screening

• Contraindication to MRI with gadolinium

• Unacceptable laboratory abnormalities

• Clinically relevant 12-lead ECG abnormalities