Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00571558
Recruitment Status : Terminated
First Posted : December 12, 2007
Last Update Posted : October 9, 2014
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE December 11, 2007
First Posted Date  ICMJE December 12, 2007
Last Update Posted Date October 9, 2014
Study Start Date  ICMJE March 2008
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
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
Change History Complete list of historical versions of study NCT00571558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2013)
  • Clinical response [ Time Frame: 1 month ]
  • Clinical response [ Time Frame: 3 months ]
  • Histologic response [ Time Frame: 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
  • Clinical response at 1 and 3 months
  • Histologic response at 3 months
  • Mucosal risk marker modulation from baseline as measured by proliferation using Ki-67, apoptosis using TUNEL, cyclin D1, p53 expression, and DNA ploidy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia
Official Title  ICMJE Phase I Study of Photodynamic Therapy Using Pulsed Dye Laser and Oral Aminolevulinic Acid in Patients With Oral Leukoplakia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Oral Leukoplakia
Intervention  ICMJE
  • Drug: aminolevulinic acid hydrochloride
    Given PO
    Other Names:
    • 5-ALA HCl
    • ALA HCl
    • aminolevulinic acid HCl
  • Drug: photodynamic therapy
    Undergo photodynamic therapy
    Other Names:
    • Light Infusion Therapy™
    • PDT
    • therapy, photodynamic
  • Other: laboratory biomarker analysis
    Correlative studies
Study Arms  ICMJE 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.
Interventions:
  • Drug: aminolevulinic acid hydrochloride
  • Drug: photodynamic therapy
  • Other: laboratory biomarker analysis
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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 12, 2014)
15
Original Enrollment  ICMJE
 (submitted: December 11, 2007)
35
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00571558
Other Study ID Numbers  ICMJE NCI-2009-00842
NCI-2009-00842 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000579270
NU-NWU05-5-01 ( Other Identifier: Robert H. Lurie Comprehensive Cancer Center )
NWU05-5-01 ( Other Identifier: DCP )
P30CA060553 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute (NCI)
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wong Stuart Robert H. Lurie Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date February 2013

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