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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase II Study of Aminolevulinic Acid and Photodynamic Therapy in Patients With Cutaneous Carcinomas or Actinic Keratosis

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Active Not specified NCI RPCI-DS-96-55 NCI-G97-1224, NCT00002975

Trial Description

Purpose:

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.

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

Eligibility:

Eligibility criteria include the following:

• No known sensitivity to light
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomized to one of two groups. Patients in group one will have aminolevulinic acid cream applied to the skin for 4-5 hours. Patients in group two will have aminolevulinic acid cream applied to the skin for 18-24 hours. Patients will then undergo laser therapy. Patients will receive follow-up evaluations for up to 2 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Allan Oseroff, MD, PhD, Protocol chair		Ph: 716-845-5813; 800-685-6825 Email: allan.oseroff@roswellpark.org

U.S.A.
New York
	Buffalo
	Roswell Park Cancer Institute
		Clinical Trials Office - Roswell Park Cancer Institute	Ph:  877-275-7724

Registry Information
Official Title		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
Trial Start Date		1997-02-10
Trial Completion Date		2010-11-07 (estimated)
Registered in ClinicalTrials.gov		NCT00002975
Date Submitted to PDQ		1997-04-08
Information Last Verified		2008-08-28
NCI Grant/Contract Number		P30-CA16056