Status:
COMPLETED
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract
Lead Sponsor:
University of Miami
Conditions:
Head and Neck Cancer
Precancerous/Nonmalignant Condition
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
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, precancerous cells and cancer cells are killed. PURPOSE: This p...
Detailed Description
OBJECTIVES: * Determine the efficacy of photodynamic therapy with porfimer sodium in patients with pre-malignant lesions, carcinoma in situ, select superficial squamous cell carcinoma of the oral cav...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Diagnosis of 1 of the following:
- Any of the following benign lesions:
- Localized severe dysplasia, leukoplakia, erythroplakia, or other superficial lesions considered to be pre-malignant
- Carcinoma in situ
- Superficial (\< 1 cm depth of invasion) squamous cell carcinoma (SCC) of the oral cavity, oropharynx, or larynx
- T1-T3 disease
- Meets one of the following criteria:
- Failed radiation therapy and refused standard salvage surgery
- Refused radiation therapy and/or surgery as primary therapy
- No good surgical alternative with acceptable morbidity
- Condemned mucosa syndrome
- At least one upper aerodigestive tract pre-malignant lesion, carcinoma in situ, or squamous cell carcinoma previously treated with surgery and/or radiation therapy with the development of another lesion not at the site of the previously treated areas
- PATIENT CHARACTERISTICS:
- Creatinine ≤ 2 mg/dL
- AST and ALT ≤ 30% elevated
- Alkaline phosphatase ≤ 30% elevated
- Bilirubin ≤ 1.0 mg/dL
- No contraindication to anesthesia or analgesia
- No porphyria
- No hypersensitivity to porphyrins
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Exclusion
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00453336
Start Date
June 1 2003
End Date
May 1 2010
Last Update
February 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136