Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors
18 Years
N/A
Both
Head and Neck Cancer, Precancerous Condition
Trial Information
Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors
OBJECTIVES:
Primary
- To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic
therapy when administered continuously or in fractionated doses in patients with
premalignant or early stage head and neck lesions.
Secondary
- To assess the efficacy of this regimen in these patients.
OUTLINE: This is a dose-escalation study of photodynamic therapy. Patients are randomized to
1 of 2 treatment arms.
- Arm I: Patients receive oral aminolevulinic acid and then undergo continuous
photodynamic therapy 4-6 hours later.
- Arm II: Patients receive aminolevulinic acid as in arm I and then undergo fractionated
photodynamic therapy 4-6 hours later.
After completion of study therapy, patients are followed up at 1 month, every 3 months for 2
years, and then annually thereafter.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diagnosis of 1 of the following within the past 3 months:
- Erythroplakia with dysplasia
- Severe dysplasia
- Carcinoma in situ of the head and neck for which standard therapy is not
indicated, according to any of the following:
- Medical condition that precludes surgery
- Lesions that cannot be completely resected based on size or location
- Significant functional morbidity would be anticipated with further surgery
- Refused standard therapy after the treatment has been discussed and offered
- No invasive squamous cell carcinoma of the head and neck
PATIENT CHARACTERISTICS:
- ECOG performance status of 0-2
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 2 times upper limit of normal (ULN)
- AST or ALT ≤ 2 times ULN
- Alkaline phosphatase ≤ 2 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior chronic liver disease or cirrhosis of the liver
- No porphyria or hypersensitivity to porphyrins
- No significant cardiovascular history that, in the opinion of a cardiologist, would
deem the patient at risk for hypotension that may occur with oral administration of
aminolevulinic acid (Levulan®)
- No prior adverse reaction to ondansetron or lorazepam
PRIOR CONCURRENT THERAPY:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Dose-limiting toxicity
Safety Issue:
Yes
Principal Investigator
Harry Quon, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Abramson Cancer Center of the University of Pennsylvania
Authority:
Unspecified
Study ID:
CDR0000650536
NCT ID:
NCT00978081
Start Date:
January 2009
Completion Date:
Related Keywords:
- Head and Neck Cancer
- Precancerous Condition
- precancerous condition
- stage 0 hypopharyngeal cancer
- stage 0 laryngeal cancer
- stage 0 lip and oral cavity cancer
- stage 0 nasopharyngeal cancer
- stage 0 oropharyngeal cancer
- stage 0 paranasal sinus and nasal cavity cancer
- Head and Neck Neoplasms
- Precancerous Conditions
Name | Location |
|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
