A Phase II Clinical Trial on the Efficacy of Photodynamic Therapy With Porfimer Sodium (Photofrin®) for Malignant and Pre-Malignant Lesions and Condemned Mucosa Syndrome in the Upper Aerodigestive Tract
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Number of Participants Experiencing Adverse Events
Study Overview
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 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.
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 cavity, oropharynx, or larynx, or condemned mucosa syndrome in the upper aerodigestive tract.
- Determine the safety of this regimen in these patients.
OUTLINE: Patients are stratified according to disease condition (benign vs malignant).
Patients receive porfimer sodium IV over 3-5 minutes on day 1 and laser light activation on day 3 or 4.
After completion of study treatment, patients are followed at 3 and 4 months and then periodically for up to 2 years.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Single Arm
Intervention: Photodynamic Therapy (Procedure)
Single Arm
Intervention: Porfimer Sodium (Drug)
Outcomes
Primary Outcomes
Number of Participants Experiencing Adverse Events
Time Frame: 6 months
Number of participants enrolled experiencing serious adverse events and/or other non-serious events
Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment
Time Frame: 6 months
Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.
Secondary Outcomes
No secondary outcomes reported