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Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis

Primary Purpose

Precancerous/Nonmalignant Condition

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
aminolevulinic acid
laser therapy
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Precancerous/Nonmalignant Condition focused on measuring actinic keratosis

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Actinic keratosis lesion located in any of the following body sites:

    • Stratum 1*: face and neck, scalp, or upper torso

      • At least 1 clinically evident thin actinic keratosis on each side of the midline of any of the above areas
    • Stratum 2*: arms or legs

      • At least 1 clinically evident thick actinic keratosis on each arm or leg NOTE: *One patient may be in one or both strata depending on the location of the lesion(s)
  • Lesions to be treated on this protocol must not have been previously treated by other modalities for at least 2 months prior to study entry

PATIENT CHARACTERISTICS:

  • No porphyria or known hypersensitivity to porphyrins
  • No known photosensitivity disease
  • No known sensitivity to any components of aminolevulinic acid topical solution
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

  • Other concurrent topical therapies at lesion sites other than those used in this protocol are allowed
  • No other concurrent photosensitizer drugs

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Arm 1 - ALA

Arm 2

Arm 3

Arm 4

Arm 5

Arm Description

Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.

Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT

Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment

Vbeam laser pulse (photodynamic therapy) is applied to the subunit

Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart

Outcomes

Primary Outcome Measures

Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Extent That the PpIX is Photobleached by the Treatment Light

Secondary Outcome Measures

Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy
Effects of Different Treatment Conditions on Efficacy
Histological Response
PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions

Full Information

First Posted
August 31, 2007
Last Updated
May 17, 2017
Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00524485
Brief Title
Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis
Official Title
A Pilot Study to Investigate the Use of Topical Levulan® With Vbeam® Laser for the Treatment of Actinic Keratoses
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Withdrawn due to low accrual
Study Start Date
May 2005 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using topical aminolevulinic acid may be effective against actinic keratosis. PURPOSE: This randomized clinical trial is studying how well different photodynamic therapy regimens using topical aminolevulinic acid work in treating patients with actinic keratosis.
Detailed Description
OBJECTIVES: Primary To determine, using fluorescence measurements, the protoporphyrin IX (PpIX) accumulation in thin actinic keratoses (AK) and actinically damaged skin on the face, scalp, and upper torso (stratum 1) and the PpIX accumulation in thick AK and actinically damaged skin on the arms and legs (stratum 2) as a function of skin preparation, aminolevulinic acid (ALA) application time, and body site. To determine the extent that the PpIX is photobleached by the treatment light. Secondary To assess the effects of different treatment conditions on acute reactions of AK and sun damaged skin to ALA-photodynamic therapy (PDT) occurring 24-48 hours after PDT. To assess the effects of different treatment conditions on the efficacy of ALA-PDT. To examine the histological response to ALA-PDT. To determine, using fluorescence measurements, the PpIX accumulation in incidental thick AK that may occur in stratum 1, and the PpIX accumulation in incidental thin AK that may occur in stratum 2 as a function of skin preparation, ALA application time and body site. To determine the extent that the PpIX in these incidental lesions is photobleached by treatment light. OUTLINE: The randomization is a two-step restricted block process for application time and skin preparation, followed by randomization for light dose (1 vs 2 pulses) within the anatomic site. Within each stratum (stratum 1 or 2), lesions in each separate anatomic area (face and neck, scalp, upper torso; arms, legs) are randomized to receive 1 of 3 pretreatment skin preparation before receiving topical aminolevulinic acid (ALA): pretreatment with acetone, gentle abrading, or no pretreatment. Patients are randomized to receive ALA at different times before the photodynamic therapy (PDT). Arm I: Patients receive topical ALA 2 hours before PDT. Arm II: Patients receive topical ALA 4 hours before PDT. Arm III: Patients receive topical ALA 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment. Arm IV: 1 Vbeam laser pulse (photodynamic therapy) is applied to the subunit. Arm V: 2 Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart. Patients with progressive lesions or lesions that have not responded after 3 treatments may receive diagnostic biopsy to check for invasive squamous cell carcinoma and referred to treatment off study. Patients undergo biopsies at baseline, before and after ALA application prior to light treatment, and up to 24 hours after light treatment to analyze cytokines and genes specific to actinic keratoses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous/Nonmalignant Condition
Keywords
actinic keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 - ALA
Arm Type
Experimental
Arm Description
Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT
Arm Title
Arm 3
Arm Type
Experimental
Arm Description
Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
Vbeam laser pulse (photodynamic therapy) is applied to the subunit
Arm Title
Arm 5
Arm Type
Experimental
Arm Description
Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart
Intervention Type
Drug
Intervention Name(s)
aminolevulinic acid
Intervention Type
Procedure
Intervention Name(s)
laser therapy
Primary Outcome Measure Information:
Title
Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Title
Extent That the PpIX is Photobleached by the Treatment Light
Secondary Outcome Measure Information:
Title
Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy
Title
Effects of Different Treatment Conditions on Efficacy
Title
Histological Response
Title
PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Title
Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Actinic keratosis lesion located in any of the following body sites: Stratum 1*: face and neck, scalp, or upper torso At least 1 clinically evident thin actinic keratosis on each side of the midline of any of the above areas Stratum 2*: arms or legs At least 1 clinically evident thick actinic keratosis on each arm or leg NOTE: *One patient may be in one or both strata depending on the location of the lesion(s) Lesions to be treated on this protocol must not have been previously treated by other modalities for at least 2 months prior to study entry PATIENT CHARACTERISTICS: No porphyria or known hypersensitivity to porphyrins No known photosensitivity disease No known sensitivity to any components of aminolevulinic acid topical solution Not pregnant or nursing PRIOR CONCURRENT THERAPY: Other concurrent topical therapies at lesion sites other than those used in this protocol are allowed No other concurrent photosensitizer drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Zeitouni, MD,
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis

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