Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2009 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00978081
First received: September 15, 2009
Last updated: April 12, 2012
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Head and Neck Cancer
Precancerous Condition
Drug: aminolevulinic acid hydrochloride
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Dose-limiting toxicity [ Designated as safety issue: Yes ]
  • Maximum tolerated dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2009
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
Drug: aminolevulinic acid hydrochloride
Patients undergo continuous or fractionated photodynamic therapy.
Experimental: Arm II
Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.
Drug: aminolevulinic acid hydrochloride
Patients undergo continuous or fractionated photodynamic therapy.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00978081

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-4283
Contact: Clinical Trials Office - Abramson Cancer Center of the Univers    800-474-9892      
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: Harry Quon, MD Abramson Cancer Center of the University of Pennsylvania
  More Information

Additional Information:
No publications provided

Responsible Party: Stephen Michael Hahn, Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00978081     History of Changes
Other Study ID Numbers: CDR0000650536, UPCC-18308, IRB #809093
Study First Received: September 15, 2009
Last Updated: April 12, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Head and Neck Neoplasms
Precancerous Conditions
Neoplasms by Site
Neoplasms
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014