Status:
COMPLETED
Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Cancer
Precancerous Condition
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
Brief Summary
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, tumor cells are killed. PURPOSE: This randomized phase I trial ...
Detailed Description
OBJECTIVES: Primary * To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic therapy when administered continuously or in fractionated doses in patients with premaligna...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00978081
Start Date
January 1 2009
End Date
November 1 2016
Last Update
April 23 2019
Active Locations (1)
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1
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283