Photodynamic Therapy in Treating Patients With Premalignant or Early Stage Head and Neck Tumors
This study is currently recruiting participants.
Verified September 2009 by National Cancer Institute (NCI)
Sponsor:
Abramson Cancer Center of the University of Pennsylvania
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
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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
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 |
Radiation-Sensitizing Agents Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013