Clinical Trials Logo

Clinical Trial Summary

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid may be effective in treating patients with skin cancer.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy that includes aminolevulinic acid works in treating patients with skin cancer.


Clinical Trial Description

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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00002975
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date February 1997
Completion date April 2010

See also
  Status Clinical Trial Phase
Completed NCT01946217 - Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials N/A
Completed NCT00653146 - The Effects of MBSR in Improving Immune Response to Human Papillomavirus in Patients With Cervical Dysplasia N/A
Completed NCT00550589 - Cidofovir in Treating HIV-Infected Patients With High-Grade Squamous Intraepithelial Lesions of the Skin Near the Anus Phase 2
Terminated NCT00629577 - Gene Expression Profiling of Cervical Cancer Progression in Biopsies and Tissue Samples Phase 1
Completed NCT00103246 - Photodynamic Therapy Using Silicon Phthalocyanine 4 in Treating Patients With Actinic Keratosis, Bowen's Disease, Skin Cancer, or Stage I or Stage II Mycosis Fungoides Phase 1
Completed NCT00066430 - Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia Phase 1
Completed NCT00522197 - ACAPHA in Preventing Lung Cancer in Former Smokers With Bronchial Intraepithelial Neoplasia Phase 2
Completed NCT00003384 - Protein Expression as a Potential Diagnostic Biomarker of Cervical Dysplasia and/or Cancer N/A
Terminated NCT02574442 - Pilot Study In Vivo Confocal Microscopy Probe for Cervical Precancer
Completed NCT00719563 - American Ginseng in Treating Patients With Fatigue Caused by Cancer Phase 3
Terminated NCT00899951 - Studying Fentanyl in Patients With Cancer N/A
Completed NCT00873288 - Activating Collaborative CIS Support Via Targeted Provider Mailing N/A
Terminated NCT00611650 - Green Tea Extract in Treating Current or Former Smokers With Bronchial Dysplasia Phase 2
Completed NCT00462813 - Diindolylmethane in Treating Patients With Abnormal Cervical Cells Phase 3
Completed NCT00006348 - Ondansetron in Treating Patients With Advanced Cancer and Chronic Nausea and Vomiting Not Caused by Cancer Treatment Phase 3
Completed NCT00666731 - Breast Cancer Registry for Participants With Breast Cancer or Characteristics of Hereditary Breast Cancer
Recruiting NCT04445532 - Hepatobiliary Tumors Tissue Samples Acquisition
Completed NCT00685568 - Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis Phase 1
Terminated NCT00942422 - Green Tea Extract in Treating Patients With Monoclonal Gammopathy of Undetermined Significance and/or Smoldering Multiple Myeloma Phase 2
Completed NCT00788164 - Vaccine Therapy With or Without Imiquimod in Treating Patients With Grade 3 Cervical Intraepithelial Neoplasia Phase 1