Trial | NCT02070432  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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 Started
Feb 28
2014
Primary Completion
Jul 31
2016
Anticipated
Study Completion
Jul 31
2016
Anticipated
Last Update
Mar 03
2016
Estimate

Drug LUZ11

LUZ11 i.v. administration followed by laser light irradiation

LUZ11 PDT Experimental

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.

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
No Results Posted