Topical Aminolevulinic Acid in Patients With Nonmelanoma Skin Cancer

NeuroTherapia, Inc.

Status and phase

Terminated

Early Phase 1

Conditions

Non-melanomatous Skin Cancer

Treatments

Procedure: biopsy

Procedure: diagnostic imaging technique

Drug: Aminolevulinic Acid

Procedure: therapeutic conventional surgery

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00663910

P30CA043703 (U.S. NIH Grant/Contract)

CASE-9Z07-CC417

P01CA084203 (U.S. NIH Grant/Contract)

CC417 (Other Identifier)

Details and patient eligibility

About

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 will respond to photodynamic therapy.

PURPOSE: This clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.

Full 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 in vivo measurements of ALA-induced PpIX formation within different zones of the tumors as measured by fluorescence detection methods.
To correlate the level of PpIX fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors.
To establish a skin cancer tissue bank.

OUTLINE: Topical aminolevulinic acid (ALA) is applied to the center of the tumor surface. Patients then undergo punch tumor biopsy of the area where the ALA is applied followed by surgery to remove the tumor. Tissue samples are assessed for protoporphyrin (PpIX) levels by fluorescence confocal microscopy and hyperspectral imaging. Excess tumor tissue may be stored in a skin cancer tissue bank. Surface measurements (from a total of 5 surface sites) of PpIX fluorescence are taken at baseline and at 2 hours after ALA application using an optical fiber-based hand-held dosimeter.

Enrollment

18 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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