We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

This study is currently recruiting participants.
Verified March 2016 by Luzitin SA
Sponsor:
ClinicalTrials.gov Identifier:
NCT02070432
First Posted: February 25, 2014
Last Update Posted: March 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Luzitin SA
  Purpose
This study will investigate the tolerability, recommended dose and pharmacokinetics of LUZ11 following photodynamic therapy (PDT) of patients with advanced head and neck cancer.

Condition Intervention Phase
Head and Neck Cancer Drug: LUZ11 Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Luzitin SA:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • LUZ11 Maximum Plasma Concentration (Cmax), Area Under the Concentration-Time Curve (AUC), Elimination Half-Life (T½), Volume of Distribution (Vd) and Clearance (CL) [ Time Frame: 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 ]

Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LUZ11 PDT

Study consists of two phases, in each participant:

  1. 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.
  2. Final PDT session with the previously identified individual effective dose.
Drug: LUZ11
LUZ11 i.v. administration followed by laser light irradiation

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070432


Locations
Portugal
Hospital CUF Porto Recruiting
Porto, Portugal, 4100-180
Contact: Lucio Lara-Santos, MD, PhD       llarasantos@gmail.com   
Principal Investigator: Lucio Lara Santos, MD, PhD         
Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto) Recruiting
Porto, Portugal, 4200-072
Contact: Lucio Lara-Santos, MD, PhD    +351225084000    llarasantos@gmail.com   
Sponsors and Collaborators
Luzitin SA
Investigators
Study Director: Luis Almeida, MD, PhD Luzitin SA
  More Information

Responsible Party: Luzitin SA
ClinicalTrials.gov Identifier: NCT02070432     History of Changes
Other Study ID Numbers: LUZ11-CDU-001
2013-003133-14 ( EudraCT Number )
First Submitted: February 20, 2014
First Posted: February 25, 2014
Last Update Posted: March 3, 2016
Last Verified: March 2016

Keywords provided by Luzitin SA:
LUZ11
head and neck cancer
photodynamic therapy
Redaporfin

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms