Photodynamic Therapy Using Aminolevulinic Acid in Treating Patients With Oral Leukoplakia

NCT00571558 | Terminated Phase 1

• 5 other identifiers: NCI-2009-00842CDR0000579270NU-NWU05-5-01NWU05-5-01P30CA060553
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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.

Conditions

Oral Leukoplakia

Outcome Measures

Primary Outcomes (1)

• 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

  Up to 84 days

Secondary Outcomes (4)

• Clinical response

  1 month

• Clinical response

  3 months

• Histologic response

  3 months

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

  Up to 84 days

Study Arms (1)

Treatment (aminolevulinin acid and photodynamic therapy)

EXPERIMENTAL

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

Drug: aminolevulinic acid hydrochloride; Drug: photodynamic therapy; Other: laboratory biomarker analysis

Interventions

aminolevulinic acid hydrochloride DRUG

Given PO

Also known as: 5-ALA HCl, ALA HCl, aminolevulinic acid HCl

Treatment (aminolevulinin acid and photodynamic therapy)

photodynamic therapy DRUG

Undergo photodynamic therapy

Also known as: Light Infusion Therapy™, PDT, therapy, photodynamic

Treatment (aminolevulinin acid and photodynamic therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (aminolevulinin acid and photodynamic therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (4)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Leukoplakia, Oral

Interventions

Aminolevulinic Acid; Photochemotherapy; 1-phenyl-3,3-dimethyltriazene

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Leukoplakia; Precancerous Conditions; Mouth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Wong Stuart

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: March 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: November 1, 2010
• Last Updated: October 9, 2014

Record last verified: 2013-02

Locations

US (4)