Precancerous/Nonmalignant Condition
Conditions
Keywords
actinic keratosis
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.
Interventions
DRUGaminolevulinic acid
PROCEDURElaser therapy
Sponsors
National Cancer Institute (NCI)
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Histological Response | — |
| Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy | — |
| Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions | — |
| PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site | — |
| Effects of Different Treatment Conditions on Efficacy | — |
Countries
United States
Participant flow
Recruitment details
Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Participants by arm
| Arm | Count |
|---|---|
| Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy Arm1: Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
Arm2: Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT Arm 3: 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 4: Vbeam laser pulse (photodynamic therapy) is applied to the subunit Arm 5: 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 | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Unknown Trt Arm: Aminolevulinic Acid and Laser Therapy |
|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 15.8 |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Extent That the PpIX is Photobleached by the Treatment Light
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Primary
Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Secondary
Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Secondary
Effects of Different Treatment Conditions on Efficacy
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Secondary
Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Secondary
Histological Response
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.
Secondary
PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
Population: Study was activated prior to RPCI putting a centralize data entry and data management. Data entry of the treatment arm assignments and outcomes was done by PI's staff and has since been lost. The PI died and all attempts to retrieve the data have failed.