Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
- Conditions
- Melanoma (Skin)
- Registration Number
- NCT00007969
- Lead Sponsor
- QLT Inc.
- Brief Summary
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy may be effective in treating melanoma.
PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy in treating patients who have stage III or stage IV melanoma.
- Detailed Description
OBJECTIVES: I. Determine the safety of photodynamic therapy with verteporfin and Detox-B adjuvant in patients with stage III or IV melanoma. II. Determine the clinical response in patients treated with this regimen. III. Determine whether this regimen induces systemic cellular and humoral immune responses to melanoma antigens in these patients. IV. Determine the ablation of cutaneous tumors in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients undergo photodynamic therapy with verteporfin and Detox-B adjuvant. Treatment repeats every 2 weeks for a total of 3 courses, each to a different melanoma lesion. Both non-treated and treated tumors are measured prior to study and at months 2, 4, and 6. Immune profile is also assessed prior to study and at months 2, 4, and 6.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Mount Sinai Comprehensive Cancer Center
🇺🇸Miami Beach, Florida, United States
University of Pittsburgh Cancer Institute
🇺🇸Pittsburgh, Pennsylvania, United States
University of Colorado Cancer Center
🇺🇸Denver, Colorado, United States
Mount Sinai Comprehensive Cancer Center at Aventura
🇺🇸Aventura, Florida, United States
Missouri Baptist Cancer Center
🇺🇸Saint Louis, Missouri, United States