Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer,… (NCT00453336) | Clinical Trial Compass
CompletedPhase 2
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract
United States45 participantsStarted 2003-06
Plain-language 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.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment
Timeframe: 6 months
2
Number of Participants Experiencing Adverse Events