Status:
TERMINATED
Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Non-melanomatous Skin Cancer
Eligibility:
All Genders
18-120 years
Phase:
EARLY_PHASE1
Brief Summary
RATIONALE: Studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients wi...
Detailed Description
OBJECTIVES: * To evaluate the distribution and depth of protoporphyrin IX (PpIX) within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ALA) administration. * To obtain...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Must have at least 1 biopsy-proven nonmelanoma skin cancer with a minimum diameter of 4 mm
- No tumors located on the eyelids, distal nose, cartilaginous portions of the ears, or lips
- PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No known hypersensitivity to aminolevulinic acid or any component of this medication
- PRIOR CONCURRENT THERAPY:
- Concurrent immunosuppressive or chemotherapeutic medications allowed
- Concurrent corticosteroids (taken by mouth or large doses taken with an inhaler) allowed
- Concurrent systemic retinoids (e.g., isotretinoin, acitretin, bexarotene, alitretinoin) or vitamin A allowed
- Other concurrent medications that may affect epidermal growth and differentiation (e.g., anti-EGFR monoclonal antibodies) allowed
- No concurrent participation in another clinical trial
- No concurrent topical treatment for the target tumor or for other nonmelanoma skin cancers
- No concurrent medical therapy or radiotherapy for other cancers
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00663910
Start Date
March 1 2008
End Date
October 1 2009
Last Update
January 2 2017
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