- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00571558
Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia
Phase I Study of Photodynamic Therapy Using Pulsed Dye Laser and Oral Aminolevulinic Acid in Patients With Oral Leukoplakia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To determine the toxicity and feasibility of photodynamic therapy using pulsed laser therapy and oral aminolevulinic acid in treating patients with oral leukoplakia.
II. To define the dose-limiting toxicity and maximum tolerated dose of photodynamic therapy using pulsed laser therapy and oral aminolevulinic acid in these patients.
SECONDARY OBJECTIVES:
I. To assess the efficacy of photodynamic therapy using pulsed dye laser and oral aminolevulinic acid by examining clinical response at 1 and 3 months.
II. To determine quantitative histologic response at 3 months. III. To explore the association of response with specific molecular and biologic markers (i.e., DNA ploidy, proliferation using Ki-67, apoptosis using TUNEL, cyclin D1, and p53).
OUTLINE: This is a dose-escalation study of long pulsed dye laser light.
Patients receive aminolevulinic acid* orally (PO) 3-4 hours before undergoing photodynamic therapy using pulsed dye laser on day 1.
(Note: *Patients in cohort 1 and a latter cohort [to be determined during the course of the study] do not receive aminolevulinic acid before photodynamic therapy.)
Patients undergo biopsies of target lesions and clinically uninvolved mucosa 4-8 weeks before beginning therapy and then at 3 months for biomarker studies (DNA ploidy, p53, Ki-67, cyclin D1, and TUNEL assay). Blood is collected on days 1, 2, 14, 28, and 84 for toxicity assessment.
After completion of study treatment, patients are followed for up to 84 days.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University
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Chicago, Illinois, United States, 60637
- University of Chicago
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Chicago, Illinois, United States, 60611
- Robert H. Lurie Comprehensive Cancer Center
-
-
Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert and The Medical College of Wisconsin
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Criteria:
- Histologically confirmed oral leukoplakia with dysplasia OR oral leukoplakia with hyperplasia in a high-risk area (e.g., floor of mouth, tongue, or oropharynx)
- Multiple oral leukoplakia lesions are allowed however no more than 5 distinct lesions are biopsied and treated
- All lesions to be treated must be technically accessible by laser
- Patients with oral leukoplakia with hyperplasia in a non-high-risk location (e.g., buccal mucosa from ill-fitting dentures) are not allowed
- Must be willing to undergo baseline biopsies of leukoplakia lesion(s) and surrounding normal tissue 4-8 weeks before therapy and repeat biopsies at 3 months
- No evidence of ongoing radiation damage to the target site
- Karnofsky performance status (PS) 70-100% or Zubrod PS 0-1
- Life expectancy > 2 years
- Hemoglobin > 12 g/dL
- Platelet count > 100,000/mm^3
- ANC > 1,500/mm^3
- Creatinine =< 1.5 mg/dL
- SGPT and SGOT =< 1.5 x upper limit of normal (ULN)
- Total bilirubin =< 1.5 x ULN (a higher level of bilirubin due to a familial metabolism will be considered on an individual basis)
- Willing to adhere to avoidance of sunlight and indoor light exposure for 24 hours after treatment
- Not pregnant or nursing
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to aminolevulinic acid
- No porphyria
No uncontrolled intercurrent illness including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that, in the opinion of the investigators, would limit compliance or jeopardize the patient or integrity of the data
- Prior treatment for leukoplakia allowed
- No prior photodynamic therapy
- More than 3 months since prior participation in a clinical trial for leukoplakia
- More than 4 weeks since prior ablative therapy to the target lesion
- More than 4 weeks since prior and no concurrent psoralen or PUVA therapy
- No concurrent oral retinoids (e.g., isotretinoin)
- No concurrent use of tanning beds
- No other concurrent investigational agents
- Fertile patients must use effective contraception
- Patients with a previous diagnosis of stage I or II head and neck cancer are eligible provided definitive therapy, including radiation therapy, is completed and the patient has been rendered disease free for >= 2 years
- No chronic liver disease including those with normal liver function tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment (aminolevulinin acid and photodynamic therapy)
Patients receive aminolevulinic acid PO 3-4 hours before undergoing photodynamic therapy using pulsed dye laser on day 1.
|
Correlative studies
Given PO
Other Names:
Undergo photodynamic therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability with determination of optimal light dosing regimen, determination of dose limiting-toxicities, and maximum tolerated dose of photodynamic therapy using pulsed laser therapy and oral aminolevulinic acid
Time Frame: Up to 84 days
|
Up to 84 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical response
Time Frame: 1 month
|
1 month
|
Clinical response
Time Frame: 3 months
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3 months
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Histologic response
Time Frame: 3 months
|
3 months
|
Mucosal risk marker modulation as measured by proliferation using Ki-67, apoptosis using TUNEL, cyclin D1, p53 expression, and DNA ploidy
Time Frame: Up to 84 days
|
Up to 84 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wong Stuart, Robert H. Lurie Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2009-00842 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- P30CA060553 (U.S. NIH Grant/Contract)
- CDR0000579270
- NU-NWU05-5-01 (Other Identifier: Robert H. Lurie Comprehensive Cancer Center)
- NWU05-5-01 (Other Identifier: DCP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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