Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

Phase 2UnknownNCT02070432

Luzitin SA20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Head and Neck Cancer

Interventions

LUZ11DRUG

LUZ11 i.v. administration followed by laser light irradiation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Hospital CUF Porto

Porto, Portugal

RECRUITING

Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)

Porto, Portugal

RECRUITING

Outcomes

Primary Outcomes

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Time frame: Up to 21 days following each dose-finding PDT session, and up to 13 weeks following final PDT session

Secondary Outcomes

Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy

Time frame: Up to 21 days after each dose-finding PDT session, and up to 13 weeks after final PDT session

Data from ClinicalTrials.gov

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