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Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
LUZ11, head and neck cancer, photodynamic therapy
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: LUZ11
Type: Drug
Overall Status
Recruiting
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.
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
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Hospital CUF Porto
Porto, Portugal
Status: Recruiting
Contact: Lucio Lara-Santos, MD, PhD - llarasantos@gmail.com
Start Date
February 2014
Completion Date
December 2014
Sponsors
Luzitin SA
Source
Luzitin SA
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page