Clinical trial NCT02070432: Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer
Official title: An Open-label Study to Investigate the Tolerability, Pharmacokinetics and Anti-tumour Effect Following Photodynamic Therapy (PDT) With Single-ascending Doses of LUZ11 in Patients With Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Head and Neck Cancer
Keywords: LUZ11
head and neck cancer
photodynamic therapy
Redaporfin
Lead sponsor: Luzitin SA
Sponsor class: INDUSTRY
First posted: 2014-02-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session
Secondary outcomes:
measure: Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy
timeFrame: Up to 21 days after each dose-finding PDT session, and up to 13 weeks after final PDT session
Other outcomes:
measure: LUZ11 Maximum Plasma Concentration (Cmax), Area Under the Concentration-Time Curve (AUC), Elimination Half-Life (T½), Volume of Distribution (Vd) and Clearance (CL)
timeFrame: 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
Locations:
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: Porto
country: Portugal
facility: Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)
Study officials:
affiliation: Luzitin SA
name: Luis Almeida, MD, PhD
role: STUDY_DIRECTOR
References: