Clinical trial · Interventional
Photodynamic Therapy With Porfimer Sodium in Treating Patients With Precancerous Lesions, Cancer, or Other Disease of the Aerodigestive Tract
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Precancerous/Nonmalignant Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Photodynamic Therapy | Procedure | — | UNRESOLVED |
| Porfimer Sodium | Drug | Porfimer | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- interventionNames
- Drug: Porfimer Sodium
- Procedure: Photodynamic Therapy
Primary outcomes (2)
- measure
- Number of Patients Achieving Complete or Partial Response 4 Months After Completion of Study Treatment
- timeFrame
- 6 months
- description
- Number of subjects achieving complete response or partial response to study treatment according to RECIST Criteria version 1.0.
- measure
- Number of Participants Experiencing Adverse Events
- timeFrame
- 6 months
- description
- Number of participants enrolled experiencing serious adverse events and/or other non-serious events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (1)
- RESULTCivantos F. Photodynamic therapy for head and neck lesions in the subtropics. J Natl Compr Canc Netw. 2012 Oct 1;10 Suppl 2:S65-8. doi: 10.6004/jnccn.2012.0179. PMID 23055220