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Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Precancerous Condition

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Trial Information

Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity

Safety Issue:

Yes

Principal Investigator

Harry Quon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Abramson Cancer Center of the University of Pennsylvania

Authority:

Unspecified

Study ID:

CDR0000650536

NCT ID:

NCT00978081

Start Date:

January 2009

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Precancerous Condition
  • 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
  • Head and Neck Neoplasms
  • Precancerous Conditions

Name

Location

Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283