Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Dose-limiting toxicity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm I
Patients receive oral aminolevulinic acid and then undergo continuous photodynamic therapy 4-6 hours later.
Intervention: aminolevulinic acid hydrochloride (Drug)
Arm II
Patients receive aminolevulinic acid as in arm I and then undergo fractionated photodynamic therapy 4-6 hours later.
Intervention: aminolevulinic acid hydrochloride (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicity
Time Frame: One year
Maximum tolerated dose
Time Frame: 90 days
Secondary Outcomes
- Response rate(One year)
- Duration of response(One year)
- Time to progression(2 years)