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Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

Primary Purpose

Oral Leukoplakia

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

aminolevulinic acid hydrochloride

photodynamic therapy

laboratory biomarker analysis

About this trial

This is an interventional treatment trial for Oral Leukoplakia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern University
Robert H. Lurie Comprehensive Cancer Center
University of Chicago
Froedtert and the Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (aminolevulinin acid and photodynamic therapy)

Arm Description

Patients receive aminolevulinic acid PO 3-4 hours before undergoing photodynamic therapy using pulsed dye laser on day 1.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Clinical response

Histologic response

Mucosal risk marker modulation as measured by proliferation using Ki-67, apoptosis using TUNEL, cyclin D1, p53 expression, and DNA ploidy

Full Information

NCT ID

NCT00571558

First Posted

December 11, 2007

Last Updated

October 8, 2014

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00571558

Brief Title

Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

Official Title

Phase I Study of Photodynamic Therapy Using Pulsed Dye Laser and Oral Aminolevulinic Acid in Patients With Oral Leukoplakia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Terminated

Study Start Date

March 2008 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

This phase I trial studies the side effects and best dose of photodynamic therapy using aminolevulinic acid in treating patients with oral leukoplakia. Photodynamic therapy uses a drug, such as aminolevulinic acid, that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using aminolevulinic acid may be effective against oral leukoplakia.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Oral Leukoplakia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (aminolevulinin acid and photodynamic therapy)

Arm Type

Experimental

Arm Description

Patients receive aminolevulinic acid PO 3-4 hours before undergoing photodynamic therapy using pulsed dye laser on day 1.

Intervention Type

Drug

Intervention Name(s)

aminolevulinic acid hydrochloride

Other Intervention Name(s)

5-ALA HCl, ALA HCl, aminolevulinic acid HCl

Intervention Description

Given PO

Intervention Type

Drug

Intervention Name(s)

photodynamic therapy

Other Intervention Name(s)

Light Infusion Therapy™, PDT, therapy, photodynamic

Intervention Description

Undergo photodynamic therapy

Intervention Type

Other

Intervention Name(s)

laboratory biomarker analysis

Intervention Description

Correlative studies

Primary Outcome Measure Information:

Title

Time Frame

Up to 84 days

Secondary Outcome Measure Information:

Title

Clinical response

Time Frame

1 month

Title

Clinical response

Time Frame

3 months

Title

Histologic response

Time Frame

3 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wong Stuart

Organizational Affiliation

Robert H. Lurie Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Robert H. Lurie Comprehensive Cancer Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Facility Name

Froedtert and the Medical College of Wisconsin

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

12. IPD Sharing Statement

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Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

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