At a glance
ClinicalIndex Comparison Record- ✓Superficial squamous cell carcinoma (SCC) of oral cavity, oropharynx, or larynx with <1 cm depth of invasion, T1-T3 disease
- ✓Failed radiation therapy and refused standard salvage surgery
- ✓Refused radiation therapy and/or surgery as primary therapy
- ✓No good surgical alternative with acceptable morbidity
- ✕Porphyria
- ✕Hypersensitivity to porphyrins
- ✕Pregnancy or nursing
- ✕Contraindication to anesthesia or analgesia
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Porfimer Sodium and Photodynamic Therapy for Head and Neck Cancer and Precancerous/Nonmalignant Condition. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home.
Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.