Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Leukoplakia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aminolevulinic acid hydrochloride | Drug | Aminolevulinic Acid | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| photodynamic therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (aminolevulinin acid and photodynamic therapy)
- description
- Patients receive aminolevulinic acid PO 3-4 hours before undergoing photodynamic therapy using pulsed dye laser on day 1.
- interventionNames
- Drug: aminolevulinic acid hydrochloride
- Drug: photodynamic therapy
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- 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
- timeFrame
- Up to 84 days
Secondary outcomes (4)
- measure
- Clinical response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available