Combination Therapy With 5-FU and PDT for the Treatment of Post-transplant Premalignant Skin Disease
This trial is active, not recruiting.
|Conditions||actinic keratosis, organ or tissue transplant; complications|
|Sponsor||The Cleveland Clinic|
|Collaborator||National Cancer Institute (NCI)|
|Start date||September 2011|
|End date||November 2016|
|Trial size||40 participants|
|Trial identifier||NCT01525329, 09-1050, 1R21CA156227-01A1|
This randomized, intra-patient comparative study is designed to investigate the combination regimen of 5-FU and PDT, versus PDT alone, for its ability to generate significantly elevated levels of the target photosensitizer, 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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
Accumulation of PpIX
time frame: Day 7 of the study
time frame: At Day 14 and at 3 months post-treatment
Development of new AKs
time frame: At 3, 6, 9, and 12 months post-treatment
Male or female participants at least 18 years old.
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
|Official title||Combination Therapy With 5-Fluorouracil and Photodynamic Therapy for the Treatment of Post-transplant Premalignant Skin Disease|
|Principal investigator||Edward Maytin, MD, PhD|
|Description||This clinical trial will test a new combination of 5-fluorouracil cream (5FU) and methylaminolevate 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). 20 organ transplant recipients and 20 normal patients, with AKs on face, scalp, ears, forearms or back of the hand are enrolled 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.|
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