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A Phase II Trial of 4-5 Hour and 18-24 Hour Applications of 20% Topical ALA for Photodynamic Therapy of Cutaneous Carcinomas and Actinic Keratoses


Phase 2
N/A
N/A
Not Enrolling
Both
Non-melanomatous Skin Cancer, Precancerous Condition

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Trial Information

A Phase II Trial of 4-5 Hour and 18-24 Hour Applications of 20% Topical ALA for Photodynamic Therapy of Cutaneous Carcinomas and Actinic Keratoses


OBJECTIVES:

- Determine the efficacy of aminolevulinic acid and laser irradiation in patients with
superficial and nodular epidermally derived lesions.

OUTLINE: This is a randomized study. Patients are stratified according to lesion type
(superficial basal cell carcinoma [BCC] vs nodular BCC vs superficial squamous cell
carcinoma vs actinic keratoses). Individual lesions on patients within each stratum are
randomized to receive either a 4-5 or 18-24 hour application of aminolevulinic acid (ALA).

ALA is topically applied in a cream mixture and an occlusive dressing is placed over the
lesion. After the randomized duration of ALA application has expired, the dressing is
removed and a dye laser is used to treat the lesion.

Patients are followed for 2-5 years after treatment.

PROJECTED ACCRUAL: Up to 200 patients could be accrued, assuming 1 lesion per patient. 50
lesions are required for each stratified group.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Actinic keratoses

- Histologically proven superficial or nodular basal cell carcinoma (BCC),
squamous cell carcinoma in situ (Bowen's disease), or microinvasive squamous
cell carcinoma

- No nodular BCC greater than 4 mm thick that will not be surgically removed

- No carcinoma with uncertain margins requiring Moh's surgery

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- No known photosensitivity disease

- No porphyria or hypersensitivity to porphyrins

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Not specified

Endocrine therapy:

- Not specified

Radiotherapy:

- Not specified

Surgery:

- Not specified

Other:

- No prior treatment with systemic photosensitizer that would cause residual cutaneous
photosensitivity during study participation

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Efficacy

Safety Issue:

No

Principal Investigator

Nathalie Zeitouni, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065494

NCT ID:

NCT00002975

Start Date:

February 1997

Completion Date:

April 2010

Related Keywords:

  • Non-melanomatous Skin Cancer
  • Precancerous Condition
  • basal cell carcinoma of the skin
  • squamous cell carcinoma of the skin
  • actinic keratosis
  • Skin Neoplasms
  • Keratosis
  • Keratosis, Actinic
  • Precancerous Conditions

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263