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Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

Primary Purpose

Head and Neck Cancer

Status

Unknown status

Phase

Phase 1

Locations

Portugal

Study Type

Interventional

Intervention

LUZ11

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring LUZ11, head and neck cancer, photodynamic therapy, Redaporfin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital CUF PortoRecruiting
Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LUZ11 PDT

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events as a Measure of Safety and Tolerability

Secondary Outcome Measures

Depth of Tumor Necrosis Assessed by Diffusion-Weighted Magnetic Resonance Imaging (MRI) with Gadolinium as a Measure of Anti-Tumor Efficacy

Full Information

NCT ID

NCT02070432

First Posted

February 20, 2014

Last Updated

March 1, 2016

Sponsor

Luzitin SA

1. Study Identification

Unique Protocol Identification Number

NCT02070432

Brief Title

Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

February 2014 (undefined)

Primary Completion Date

July 2016 (Anticipated)

Study Completion Date

July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Luzitin SA

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

Keywords

LUZ11, head and neck cancer, photodynamic therapy, Redaporfin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LUZ11 PDT

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

LUZ11

Intervention Description

LUZ11 i.v. administration followed by laser light irradiation

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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 Pre-specified Outcome Measures:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis Almeida, MD, PhD

Organizational Affiliation

Luzitin SA

Official's Role

Study Director

Facility Information:

Facility Name

Hospital CUF Porto

City

Porto

ZIP/Postal Code

4100-180

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lucio Lara-Santos, MD, PhD

llarasantos@gmail.com

First Name & Middle Initial & Last Name & Degree

Lucio Lara Santos, MD, PhD

Facility Name

Instituto Português de Oncologia do Porto Francisco Gentil, EPE (IPO-Porto)

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lucio Lara-Santos, MD, PhD

Phone

+351225084000

llarasantos@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Photodynamic Therapy With LUZ11 in Advanced Head and Neck Cancer

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