Photodynamic Therapy in Treating Patients With Skin Cancer

This study has been completed.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Roswell Park Cancer Institute

ClinicalTrials.gov Identifier:

NCT00002975

First received: November 1, 1999

Last updated: September 23, 2011

Last verified: September 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

September 23, 2011

Start Date ^ICMJE

February 1997

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00002975 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Range of biological variations in PpIX levels and distributions within lesions and skin [ Designated as safety issue: No ]
Range of biological variations in the rate and extent of treatment-induced photobleaching of the PpIX and recovery from photobleaching [ Designated as safety issue: No ]
Range of biological variations in photodynamic therapy (PDT)-induced clinical epidermal toxicity [ Designated as safety issue: No ]
Range of biological variations in PDT-induced tissue damage and host responses on a microscopic level [ Designated as safety issue: No ]
Range of biological variations in the rate and extent of treatment-induced photobleaching within lesions and skin [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Photodynamic Therapy in Treating Patients With Skin Cancer

Official Title ^ICMJE

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

Brief 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.

Detailed 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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Non-melanomatous Skin Cancer
Precancerous Condition

Intervention ^ICMJE

Drug: aminolevulinic acid

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

175

Completion Date

April 2010

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00002975

Other Study ID Numbers ^ICMJE

CDR0000065494, RPCI-DS-96-55, NCI-G97-1224

Has Data Monitoring Committee

Yes

Responsible Party

Roswell Park Cancer Institute

Study Sponsor ^ICMJE

Roswell Park Cancer Institute

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Study Chair:

Nathalie Zeitouni, MD

Roswell Park Cancer Institute

Information Provided By

Roswell Park Cancer Institute

Verification Date

September 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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