A Phase 1/2 interventional study of PDL-585, ScleroPLUS laser and 5-Aminolevulinic Acid (Levulan KerastickTM) in Leukoplakia and Erythroplakia, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by University of Arkansas · Phase 1/2, Interventional, and Treatment
Oral leukoplakia within the mouth is a visible white patch which can develop into cancer if not treated. There is no good treatment for these lesions, apart from surgery which is associated with significant side effects and physical deformation of the treated area.
The investigators hypothesized that photodynamic therapy can be used safely and effectively to induce significant regression of oral leukoplakia.
This is a combined Phase I/II non-randomized prospective study designed to determine the safety and assess the clinical efficacy of PDT in the treatment of oral leukeplekia with 5-ALA and 585-nm PDL with 1.5 ms pulse time. In the first part of the study we determined the maximum tolerated dose (MTD) of the PDL radiant exposure in combination with 5-ALA. In the second phase of the study, this dose is used to treat subjects at the MTD in order to determine the efficacy of the treatment by documenting the regression of the treated lesions.
21 studies on the registry are indexed under Leukoplakia; 7 are open to participants now.
This study's enrollment of 29 is below the median of 35 across 12 interventional studies indexed under Leukoplakia.
Browse Leukoplakia studies →University of Arkansas is the lead sponsor of 399 studies on the registry; 38 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
During Phase I, to determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion. The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD). Procedure: Fluorescence Diagnosis Imaging Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 6, 7 and 8 J/cm2.
Device: PDL-585, ScleroPLUS laser · Drug: 5-Aminolevulinic Acid (Levulan KerastickTM) · Procedure: Fluorescence Diagnosis Imaging
Procedure: Fluorescence Diagnosis Imaging Interventions: Application of 5-ALA to lesion followed by activation with high power 585 nm pulsed dye laser (PDL-585, ScleroPLUS laser) at 8 J/cm2.
Device: PDL-585, ScleroPLUS laser · Drug: 5-Aminolevulinic Acid (Levulan KerastickTM) · Procedure: Fluorescence Diagnosis Imaging
PDT Treatment; emits light with 585 nm wavelength in pulses of 1.5 milliseconds in sections of 5 mm diameter to target the lesion and surrounding tissue
Topically administered; incubation time 60-180 minutes; single dose (345 mg of active 5-ALA in 1.5 ml solution); soaked onto white gauze and applied to lesion, covered with sterile Xeroform gauze
Also known as: 5-ALA
FD Image taken prior to PDL-585 usage
Maximum Tolerated Dose
The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989.
Time frame: Day 2
The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR).
The response rate was quantified by examination by an experienced head and neck surgeon and classified as follows: significant response (SR) was one where the lesion had greater than 75% resolution, partial response (PR) was one in which the lesion was reduced in size by at least 25%, and no response (NR) was one where the lesion was reduced by less than 25% in size.
Time frame: Day 90
Subjects were identified in the head and neck oncology clinic and enrolled into the study within the time period of January 1, 2007 to November 18, 2009.
| Milestone | Phase I | Phase II |
|---|---|---|
| Started | 9 | 0 |
| Completed | 9 | 0 |
| Not completed | 0 | 0 |
| Milestone | Phase I | Phase II |
|---|---|---|
| Started | 0 | 21 |
| Completed | 0 | 17 |
| Not completed | 0 | 4 |
The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989.
| J/cm2 | Phase I |
|---|---|
| Maximum Tolerated Dose | 8 |
The response rate was quantified by examination by an experienced head and neck surgeon and classified as follows: significant response (SR) was one where the lesion had greater than 75% resolution, partial response (PR) was one in which the lesion was reduced in size by at least 25%, and no response (NR) was one where the lesion was reduced by less than 25% in size.
| participants | Phase II |
|---|---|
| Participants with Significant Response (SR) | 7 |
| Participants with Partial Response (PR) | 9 |
| Participants with no Response (NR) | 1 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase I | — | 0/9 (0%) | 9/9 (100%) |
| Phase II | — | 0/21 (0%) | 2/21 (9.5%) |
| Event | Phase I | Phase II |
|---|---|---|
| PainNervous system disorders | 2/9 | 2/21 |
| Dry mouthGeneral disorders | 1/9 | 0/21 |
| Bad breathGeneral disorders | 1/9 | 0/21 |
| InsomniaGeneral disorders | 1/9 | 0/21 |
| DepressionPsychiatric disorders | 1/9 | 0/21 |
| Swollen lipGeneral disorders | 1/9 | 0/21 |
| Redness on chinGeneral disorders | 1/9 | 0/21 |
| Taste alteredGeneral disorders | 1/9 | 0/21 |
| Burning sensationGeneral disorders | 1/9 | 0/21 |
| Sensitive to coldGeneral disorders | 1/9 | 0/21 |
| Age, Customized(participants) | Phase I | Phase II | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 80 years | 11 | 18 | 29 |
| >=80 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Phase I | Phase II | Total |
|---|---|---|---|
| Female | 7 | 7 | 14 |
| Male | 4 | 11 | 15 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Aminolevulinic Acid