Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

aminolevulinic acid

Drug
Who is being recruted

Carcinoma+8

+ Keratosis

+ Neoplasms

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 1997
See protocol details

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: October 10, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 1997

Actual date on which the first participant was enrolled.

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.

NCT00002975
Principal SponsorRoswell Park Cancer Institute
Last updated: October 10, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CarcinomaKeratosisNeoplasmsNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Basal CellCarcinoma, Basal CellPrecancerous ConditionsKeratosis, Actinic

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Roswell Park Cancer Institute

Buffalo, United StatesOpen Roswell Park Cancer Institute in Google Maps
CompletedOne Study Center