Combination Therapy With 5-Fluorouracil and Photodynamic Therapy in Post-transplant Premalignant Skin Disease
| Status: | Terminated |
|---|---|
| Conditions: | Skin and Soft Tissue Infections, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/16/2018 |
| Start Date: | September 2011 |
| End Date: | December 2016 |
Combination Therapy With 5-Fluorouracil and Photodynamic Therapy for the Treatment of Post-transplant Premalignant Skin Disease
This randomized, intra-patient comparative study is designed to investigate the combination
regimen of 5-fluorouracil cream (5FU) and Photodynamic Therapy (PDT), versus PDT alone, for
its ability to generate significantly elevated levels of the target photosensitizer,
protoporphyrin IX (PpIX), in lesions of actinic keratoses (AKs) and to more effectively treat
and prevent recurrence of AKs. The target population comprises patients with solid organ
transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for
possible influences of immunosuppression.
regimen of 5-fluorouracil cream (5FU) and Photodynamic Therapy (PDT), versus PDT alone, for
its ability to generate significantly elevated levels of the target photosensitizer,
protoporphyrin IX (PpIX), in lesions of actinic keratoses (AKs) and to more effectively treat
and prevent recurrence of AKs. The target population comprises patients with solid organ
transplants (renal, hepatic), as well as normal (immunocompetent) subjects to control for
possible influences of immunosuppression.
This clinical trial will test a new combination of 5-fluorouracil cream (5FU) and
methylaminolevulinate photodynamic therapy (MAL-PDT), versus MAL-PDT alone, as treatment for
actinic keratoses (AKs) in immunosuppressed organ transplant recipients (OTRs) and an
immunocompetent control group. Objectives: 1) Determine whether topical pretreatment with
5-FU selectively increases the amount of photosensitizer (PpIX) produced within AK lesions,
relative to non-pretreated lesions. 2) Determine whether the combination treatment improves
lesion resolution and reduces the incidence of new AKs. 3) Determine whether biomarkers in
tissue and blood are predictive of patient responsiveness to 5FU (PpIX induction, new lesion
incidence, and clinical toxicity).
We plan to enroll 20 organ transplant recipients and 20 normal patients, with AKs on face,
scalp, ears, forearms or back of the hand through Dermatology and Transplant Clinic at
Cleveland Clinic. Women of childbearing age must use contraception and have a negative
pregnancy test.
Study participants will apply 5FU daily for 6 days; MAL/PDT is administered on 7th day. PpIX
will be measured in lesions using a noninvasive dosimeter. Biopsies will be taken from
selected lesions, and AKs will be photographed. Participants will be asked to complete a
questionnaire to document adverse events. Patients are evaluated at day 14, and months 3, 6,
9, 12, to document AK clearance and new lesion appearance.
methylaminolevulinate photodynamic therapy (MAL-PDT), versus MAL-PDT alone, as treatment for
actinic keratoses (AKs) in immunosuppressed organ transplant recipients (OTRs) and an
immunocompetent control group. Objectives: 1) Determine whether topical pretreatment with
5-FU selectively increases the amount of photosensitizer (PpIX) produced within AK lesions,
relative to non-pretreated lesions. 2) Determine whether the combination treatment improves
lesion resolution and reduces the incidence of new AKs. 3) Determine whether biomarkers in
tissue and blood are predictive of patient responsiveness to 5FU (PpIX induction, new lesion
incidence, and clinical toxicity).
We plan to enroll 20 organ transplant recipients and 20 normal patients, with AKs on face,
scalp, ears, forearms or back of the hand through Dermatology and Transplant Clinic at
Cleveland Clinic. Women of childbearing age must use contraception and have a negative
pregnancy test.
Study participants will apply 5FU daily for 6 days; MAL/PDT is administered on 7th day. PpIX
will be measured in lesions using a noninvasive dosimeter. Biopsies will be taken from
selected lesions, and AKs will be photographed. Participants will be asked to complete a
questionnaire to document adverse events. Patients are evaluated at day 14, and months 3, 6,
9, 12, to document AK clearance and new lesion appearance.
Inclusion Criteria:
- At least 18 years of age
- At least four (4) actinic keratoses, located on face, ears, scalp, forearms and/or
dorsal hands. - Patients in the solid organ transplant arm of the study must have had
either a kidney or liver transplant, and the transplantation surgery must have
occurred at least 2 years prior to enrollment.
Exclusion Criteria:
- Pregnant or nursing
- Currently participating in another clinical trial
- Using any topical treatment for their actinic keratoses
- Currently being treated for other cancers with medical or radiation therapy
- Patients with a known hypersensitivity to 5-aminolevulinic acid, 5-fluorouracil or any
component of the study material
- Patients with a history of a photosensitivity disease, including porphyria cutanea
tarda
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