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

September 15, 2009
April 12, 2012
January 2009
July 2015   (final data collection date for primary outcome measure)
  • Dose-limiting toxicity [ Designated as safety issue: Yes ]
  • Maximum tolerated dose [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00978081 on ClinicalTrials.gov Archive Site
  • Response rate [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
  • Time to progression [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Primary Purpose: Treatment
  • Head and Neck Cancer
  • Precancerous Condition
Drug: aminolevulinic acid hydrochloride
Patients undergo continuous or fractionated photodynamic therapy.
  • Experimental: Arm I
    Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
    Intervention: Drug: aminolevulinic acid hydrochloride
  • Experimental: Arm II
    Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.
    Intervention: Drug: aminolevulinic acid hydrochloride
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
Not Provided
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT00978081
CDR0000650536, UPCC-18308, IRB #809093
Not Provided
Stephen Michael Hahn, Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
Principal Investigator: Harry Quon, MD Abramson Cancer Center of the University of Pennsylvania
National Cancer Institute (NCI)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP