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.
1This trial used photodynamic therapy with porfimer sodium for conditions ranging from precancerous lesions to actual cancers of the aerodigestive tract — given my specific diagnosis, is PDT with porfimer sodium a realistic option for me, or would standard treatments like surgery or radiation make more sense first?
2Since this was a Phase 2 trial and it's now completed, what did the results show about how many patients had a complete or partial response four months after treatment, and how does that compare to what I might expect from conventional approaches?
3The trial tracked adverse events as a primary outcome, which suggests there were real safety concerns worth understanding — what are the most common or serious side effects associated with porfimer sodium PDT, particularly things like sun sensitivity or damage to surrounding tissue in the throat or airway?
4Porfimer sodium PDT requires light activation after the drug is given, which involves specific procedures and follow-up visits — logistically, what would my treatment schedule actually look like, and are there lifestyle restrictions like avoiding sunlight that I'd need to plan around?
5Now that this trial is completed, are there follow-on studies or standard clinical protocols using porfimer sodium PDT for my type of lesion or condition that I could potentially access today?
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