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A Phase 1/2 Uncontrolled, Open Label Study Of Photodynamic Vaccination In Patients With Stage III/IV Malignant Melanoma
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Colorado Cancer Center
Denver, Colorado, United States
Mount Sinai Comprehensive Cancer Center at Aventura
Aventura, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Missouri Baptist Cancer Center
St Louis, Missouri, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Start Date
October 1, 2000
Last Updated
November 6, 2013
Detox-B adjuvant
BIOLOGICAL
verteporfin
DRUG
Lead Sponsor
QLT Inc.
NCT04079166
NCT04911998
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