Combination Therapy With 5-FU and PDT for the Treatment of Post-transplant Premalignant Skin Disease

This study is currently recruiting participants.

Verified February 2013 by The Cleveland Clinic

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Edward Maytin, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT01525329

First received: January 31, 2012

Last updated: February 14, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	January 31, 2012
Last Updated Date	February 14, 2013
Start Date ^ICMJE	September 2011
Estimated Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 31, 2012)	Accumulation of PpIX [ Time Frame: Day 7 of the study ] [ Designated as safety issue: No ] The primary endpoint of this study will be the accumulation of PpIX at 3 h after MAL application (measured noninvasively, in each treated region). (Region refers to the half-face or half-scalp area treated with PDT monotherapy, or the contralateral area treated with the 5-FU/PDT combination regimen).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01525329 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 31, 2012)	AK clearance [ Time Frame: At Day 14 and at 3 months post-treatment ] [ Designated as safety issue: No ] 1) Rate of AK clearance at Day 14 (at the time of suture removal) and at 3 months Development of new AKs [ Time Frame: At 3, 6, 9, and 12 months post-treatment ] [ Designated as safety issue: No ] Rate of development of new AK at months 3, 6 9, and 12
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Combination Therapy With 5-FU and PDT for the Treatment of Post-transplant Premalignant Skin Disease
Official Title ^ICMJE	Combination Therapy With 5-Fluorouracil and Photodynamic Therapy for the Treatment of Post-transplant Premalignant Skin Disease
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Actinic Keratosis Organ or Tissue Transplant; Complications
Intervention ^ICMJE	Drug: 5-Fluorouracil All patients will receive one cream, 5-Fluorouracil, and will be instructed to apply the cream according to the randomization schema to AKs on either the right or left side of the face/scalp once a day for 6 days prior to PDT. A baseline measurement of the tumor's ability to produce PpIX will be done by applying methyl-aminolevulinic acid (Metvixia® topical cream) to the selected AKs and using the Aurora© dosimeter. Prior to Metvixia, and again 3 hours after application, surface measurements of the PpIX fluorescence will be taken. Then, the two largest precancer lesions (one on the left side, one on the right side) will be biopsied under local anesthesia, followed by red light PDT (lasting ~8 minutes). The biopsy sites will be shielded from the light with a circular spot bandage. Other Names: Fluorouracil Cream, USP 5% 5-FU
Study Arm (s)	Experimental: Solid Organ Transplant with AKs Patients who have undergone kidney or liver transplant within 2 years and have at least 4 premalignant skin lesions on the face, ears, scalp, forearms and/or dorsal hands. Intervention: Drug: 5-Fluorouracil Active Comparator: Actinic Keratoses Patients with at least 4 actinic keratoses on the face, ears, scalp, forearms and/or dorsal hands. Intervention: Drug: 5-Fluorouracil
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	40
Estimated Completion Date	December 2014
Estimated Primary Completion Date	July 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01525329
Other Study ID Numbers ^ICMJE	09-1050, 1R21CA156227-01A1
Has Data Monitoring Committee	Yes
Responsible Party	Edward Maytin, The Cleveland Clinic
Study Sponsor ^ICMJE	The Cleveland Clinic
Collaborators ^ICMJE	National Cancer Institute (NCI)
Investigators ^ICMJE	Not Provided
Information Provided By	The Cleveland Clinic
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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