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

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ClinicalTrials.gov Identifier: NCT00978081
Recruitment Status : Completed
First Posted : September 16, 2009
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Abramson Cancer Center at Penn Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Precancerous Condition Drug: aminolevulinic acid hydrochloride Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors
Study Start Date : January 2009
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Dose-limiting toxicity [ Time Frame: One year ]
  2. Maximum tolerated dose [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: One year ]
  2. Duration of response [ Time Frame: One year ]
  3. Time to progression [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978081


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Sponsors and Collaborators
Abramson Cancer Center at Penn Medicine
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Peter Ahn, MD Abramson Cancer Center at Penn Medicine
More Information
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Additional Information:

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Responsible Party: Abramson Cancer Center at Penn Medicine
ClinicalTrials.gov Identifier: NCT00978081    
Obsolete Identifiers: NCT01019954
Other Study ID Numbers: CDR0000650536
UPCC-18308
IRB #809093
First Posted: September 16, 2009    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Keywords provided by Abramson Cancer Center at Penn Medicine:
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:
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Head and Neck Neoplasms
Precancerous Conditions
Neoplasms by Site
Neoplasms
 Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents