Head and Neck Cancer
Conditions
Keywords
LUZ11, head and neck cancer, photodynamic therapy, Redaporfin
Brief 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.
Detailed description
LUZ11 is a new photosensitizer for use in photodynamic therapy (PDT) of solid tumors, such as head and neck cancer. PDT with LUZ11 involves the intravenous administration of LUZ11 followed by irradiation of the target tumor with laser light of an appropriate wavelength. The light causes the drug to react with oxygen, which forms reactive oxygen species (ROS) locally and induces tumor cells death and damages the blood vessels of the tumor thus preventing it from receiving nutrients. The primary objective of this study is to assess the tolerability of LUZ11 following single ascending doses of LUZ11. The secondary objectives of this study are to explore the LUZ11 dose that has anti-tumor effect following photoactivation and to determine LUZ11 pharmacokinetics.
Interventions
DRUGLUZ11
LUZ11 i.v. administration followed by laser light irradiation
Sponsors
Luzitin SA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events as a Measure of Safety and Tolerability | Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session |
Secondary
| Measure | Time frame |
|---|---|
| Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy | Up to 21 days after each dose-finding PDT session, and up to 13 weeks after final PDT session |
Other
| Measure | Time frame |
|---|---|
| LUZ11 Maximum Plasma Concentration (Cmax), Area Under the Concentration-Time Curve (AUC), Elimination Half-Life (T½), Volume of Distribution (Vd) and Clearance (CL) | Prior to dose, immediately after dose, and at 0.08, 0.5, 0.75, 1, 3, 6, 12, 24, 48 and 72 hours post-dose |
Countries
Portugal
Outcome results
None listed