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Trial Title:
Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer
NCT ID:
NCT02070432
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
LUZ11
head and neck cancer
photodynamic therapy
Redaporfin
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
LUZ11
Description:
LUZ11 i.v. administration followed by laser light irradiation
Arm group label:
LUZ11 PDT
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.
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital CUF Porto
Address:
City:
Porto
Zip:
4100-180
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Lucio Lara-Santos, MD, PhD
Email:
llarasantos@gmail.com
Investigator:
Last name:
Lucio Lara Santos, MD, PhD
Email:
Principal Investigator
Facility:
Name:
Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)
Address:
City:
Porto
Zip:
4200-072
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Lucio Lara-Santos, MD, PhD
Phone:
+351225084000
Email:
llarasantos@gmail.com
Start date:
February 2014
Completion date:
July 2016
Lead sponsor:
Agency:
Luzitin SA
Agency class:
Industry
Source:
Luzitin SA
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02070432
