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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00571558 |
RATIONALE: 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.
PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using aminolevulinic acid in treating patients with oral leukoplakia.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer Precancerous/Nonmalignant Condition |
Drug: aminolevulinic acid Procedure: DNA ploidy analysis Procedure: laboratory biomarker analysis Procedure: molecular diagnostic method |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Trial of ALA PDT for Treatment of Oral Leukoplakia |
Estimated Enrollment: | 35 |
Study Start Date: | March 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of long pulsed dye laser light.
Patients receive oral aminolevulinic acid* 3-4 hours before 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed oral leukoplakia with dysplasia OR oral leukoplakia with hyperplasia in a high-risk area (e.g., floor of mouth, tongue, or oropharynx)
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
United States, Illinois | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Wisconsin | |
Medical College of Wisconsin Cancer Center | Recruiting |
Milwaukee, Wisconsin, United States, 53226 | |
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C 414-805-4380 |
Study Chair: | Stuart J. Wong, MD | Medical College of Wisconsin |
Principal Investigator: | Raymond C. Bergan, MD | Robert H. Lurie Cancer Center |
Study ID Numbers: | CDR0000579270, NU-NWU05-5-01 |
Study First Received: | December 11, 2007 |
Last Updated: | December 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00571558 |
Health Authority: | Unspecified |
lip and oral cavity cancer oropharyngeal cancer oral leukoplakia |
Mouth Diseases Pathological Conditions, Anatomical Oral leukoplakia Leukoplakia, Oral Precancerous Conditions Oral cancer |
Head and Neck Neoplasms Leukoplakia Stomatognathic Diseases Lip and oral cavity cancer Mouth Neoplasms Aminolevulinic Acid |
Photosensitizing Agents Neoplasms Neoplasms by Site Radiation-Sensitizing Agents |
Therapeutic Uses Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |