Melanoma (Skin) Clinical Trial
Official title:
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.
;
Primary Purpose: Treatment
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