Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02070432
• Other study ID #: LUZ11-CDU-001
• Secondary ID: 2013-003133-14
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: February 20, 2014
• Last updated: March 1, 2016
• Start date: February 2014
• Est. completion date: July 2016

Study information

• Verified date: March 2016
• Source: Luzitin SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: INFARMED, National Authority of Medicines and Health Products, IP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• LUZ11
LUZ11 i.v. administration followed by laser light irradiation

Locations

Country	Name	City	State
Portugal	Hospital CUF Porto	Porto
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Luzitin SA

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	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	No