Clinical trial NCT00978081: Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
Official title: Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Precancerous Condition
Keywords: precancerous condition
stage 0 hypopharyngeal cancer
stage 0 laryngeal cancer
stage 0 lip and oral cavity cancer
stage 0 nasopharyngeal cancer
stage 0 oropharyngeal cancer
stage 0 paranasal sinus and nasal cavity cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-16
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 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.

Detailed description: OBJECTIVES:

Primary

* To evaluate the toxicities associated with aminolevulinic acid-mediated photodynamic therapy when administered continuously or in fractionated doses in patients with premalignant or early stage head and neck lesions.

Secondary

* To assess the efficacy of this regimen in these patients.

OUTLINE: This is a dose-escalation study of photodynamic therapy. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
* Arm II: Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.

After completion of study therapy, patients are followed up at 1 month, every 3 months for 2 years, and then annually thereafter.

Eligibility criteria: 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 specified

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: One year
measure: Maximum tolerated dose
timeFrame: 90 days
Secondary outcomes:
measure: Response rate
timeFrame: One year
measure: Duration of response
timeFrame: One year
measure: Time to progression
timeFrame: 2 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Peter Ahn, MD
role: PRINCIPAL_INVESTIGATOR
References: