Back to resultsPhotodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
Primary Purpose
Head and Neck Cancer, Precancerous Condition
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
aminolevulinic acid hydrochloride
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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
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
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm I
Arm II
Arm Description
Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.
Outcomes
Primary Outcome Measures
Dose-limiting toxicity
Maximum tolerated dose
Secondary Outcome Measures
Response rate
Duration of response
Time to progression
Full Information
NCT ID
NCT00978081
First Posted
September 15, 2009
Last Updated
April 22, 2019
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00978081
Brief Title
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
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.
Intervention Type
Drug
Intervention Name(s)
aminolevulinic acid hydrochloride
Intervention Description
Patients undergo continuous or fractionated photodynamic therapy.
Primary Outcome Measure Information:
Title
Dose-limiting toxicity
Time Frame
One year
Title
Maximum tolerated dose
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Response rate
Time Frame
One year
Title
Duration of response
Time Frame
One year
Title
Time to progression
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Ahn, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cancer.gov/clinicaltrials
Description
Clinical trial summary from the National Cancer Institute's PDQ® database
Learn more about this trial
Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
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