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Trial record 17 of 537 for:    "Skin cancer"

Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients (PDT)

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ClinicalTrials.gov Identifier: NCT02751151
Recruitment Status : Recruiting
First Posted : April 26, 2016
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
DUSA Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:
The study will draw patients from the Transplant Dermatology specialty clinic, where the investigators see organ transplant recipients (OTR) for regular screening and serve as a regional referral center for this population. Enrollment will be limited to 20 patients. Inclusion criteria are organ transplant recipients status, active immunosuppression for at least 5 years, and history of at least one NMSC.

Condition or disease Intervention/treatment Phase
Nonmelanoma Skin Cancers Other: have Levulan Kerastick (aminolevulinic acid) solution Phase 2

Detailed Description:

Patients will receive Levulan Kerastick (aminolevulinic acid) to the face and/or scalp (if both are needed, treated separately on back to back days); incubation: 2.5 hours and blue light photodynamic therapy utilizing the DUSA BLU-U device; illumination: 1000 seconds (16 min, 40 secs); administered quarterly for 3 years. Patients who change systemic immunosuppression regimens or add or increase systemic chemoprevention while in the study will be excluded from the overall analysis. The patients will be evaluated by the principal investigator every 3 months, prior to photodynamic therapy (PDT) administration.

Primary endpoints include:

  1. development of non melanoma skin cancers (NMSC) lesions and
  2. assessment of actinic damage score.

The primary endpoint will be development of new skin cancers at 3 years, based on comparison to rate at baseline from previous (x) year(s) using absolute slope value for number prior to treatment vs. number after treatment. The patients will serve as their own controls and the investigators will analyze the delta in development of non melanoma skin cancers and actinic damage score pre- and post- treatment.

Additionally, an actinic damage score will be assigned based on the number of actinic keratosis on initial evaluation. At each 3 month follow up visit, the actinic damage score will be reassessed. The investigators will be able to secondarily analyze the delta in the actinic damage score on treatment.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients
Study Start Date : February 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Experimental: 1
Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered
Other: have Levulan Kerastick (aminolevulinic acid) solution
Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered




Primary Outcome Measures :
  1. Number of non melanoma skin cancers in organ transplant recipients [ Time Frame: through study completion, an average of 2 years ]

Secondary Outcome Measures :
  1. Reduction of actinic keratosis damage/epidermal dysplasia in organ transplant recipients as assessed by physician and graded per actinic damage scale [ Time Frame: through study completion, an average of 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. The patient has been the recipient of any solid organ transplant.
  2. Active immunosuppression for at least 5 years
  3. History of at least one NMSC
  4. Subject is willing to sign an informed consent to participate in this study.

Exclusion Criteria:

  1. Patient is not appropriate candidate for treatment or research trial per treating physician
  2. Patient has a mental health condition that makes them unable to participate in this research trial, per PI judgment.
  3. Patient is on additional immunosuppression for diagnosis unrelated to organ transplant -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751151


Contacts
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Contact: Kelly Jeffords 703-208-6606 kelly.jeffords@inova.org

Locations
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United States, Virginia
Inova Melanoma Na Skin Oncology Center Recruiting
Fairfax, Virginia, United States, 22031
Contact: Kelly Jeffords    703-208-6606    kelly.jeffords@inova.org   
Principal Investigator: Jennifer DeSimone, MD         
Sponsors and Collaborators
Inova Health Care Services
DUSA Pharmaceuticals, Inc.
Investigators
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Principal Investigator: Jennifer DeSimone, MD Physician

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Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT02751151     History of Changes
Other Study ID Numbers: 15-1845
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018

Additional relevant MeSH terms:
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Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents