Clinical trial · Interventional
Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors
NCT00978081CI-TRIAL-00038288completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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, tumor cells are killed. PURPOSE: This randomized phase I trial is studying the side effects and best dose of photodynamic therapy in treating patients with premalignant or early stage head and neck tumors.
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 Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aminolevulinic acid hydrochloride | Drug | Aminolevulinic Acid | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
- interventionNames
- Drug: aminolevulinic acid hydrochloride
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.
- interventionNames
- Drug: aminolevulinic acid hydrochloride
Primary outcomes (2)
- measure
- Dose-limiting toxicity
- timeFrame
- One year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed diagnosis of 1 of the following within the past 3 months:
* Erythroplakia with dysplasia
* Severe dysplasia
* Carcinoma in situ of the head and neck for which standard therapy is not indicated, according to any of the following:
* Medical condition that precludes surgery
* Lesions that cannot be completely resected based on size or location
* Significant functional morbidity would be anticipated with further surgery
* Refused standard therapy after the treatment has been discussed and offered
* No invasive squamous cell carcinoma of the head and neck
PATIENT CHARACTERISTICS:
* ECOG performance status of 0-2
* Platelet count ≥ 100,000/mm\^3
* Total bilirubin ≤ 2 times upper limit of normal (ULN)
* AST or ALT ≤ 2 times ULN
* Alkaline phosphatase ≤ 2 times ULN
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chronic liver disease or cirrhosis of the liver
* No porphyria or hypersensitivity to porphyrins
* No significant cardiovascular history that, in the opinion of a cardiologist, would deem the patient at risk for hypotension that may occur with oral administration of aminolevulinic acid (Levulan®)
* No prior adverse reaction to ondansetron or lorazepam
PRIOR CONCURRENT THERAPY:
* Not specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.