Phase 2
N=45
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract
Head and Neck Cancer · Precancerous/Nonmalignant Condition
Bottom Line
View on ClinicalTrials.gov: NCT00453336 ↗Enrolled (actual)
45
Serious AEs
53.3%
Results posted
Oct 2013
Primary outcome: Primary: Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment — 32 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Porfimer Sodium (Drug); Photodynamic Therapy (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Aug 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment |
32 | — |
| PRIMARY Number of Participants Experiencing Adverse Events |
36 | — |
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 phase II trial is studying the side effects and how well photodynamic therapy with porfimer sodium works in treating patients with precancerous lesions, cancer, or other disease of the aerodigestive tract.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00453336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.