Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

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

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

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: LUZ11

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4100-180
    • Recruiting
    • Hospital CUF Porto
    • Contact: Lucio Lara-Santos, MD, PhD; Email: llarasantos@gmail.com
    • Principal Investigator: Lucio Lara Santos, MD, PhD
  • Porto, Portugal, 4200-072
    • Recruiting
    • Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)
    • Contact: Lucio Lara-Santos, MD, PhD; Phone Number: +351225084000; Email: llarasantos@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LUZ11 PDT; Study consists of two phases, in each participant: Dose-finding phase with sequential periods in which single-ascending doses of LUZ11 will be titrated up to a dose that shows to be effective following photoirradiation of small spots of tumor surface.; Final PDT session with the previously identified individual effective dose.	Drug: LUZ11; LUZ11 i.v. administration followed by laser light irradiation

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Luzitin SA
• Investigators: Study Director: Luis Almeida, MD, PhD, Luzitin SA

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: February 20, 2014
• First Submitted That Met QC Criteria: February 21, 2014
• First Posted (Estimate): February 25, 2014

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: March 1, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: head and neck cancer; photodynamic therapy; LUZ11; Redaporfin
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: LUZ11-CDU-001; 2013-003133-14 (EudraCT Number)