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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