A Phase 1/2 Uncontrolled, Open Label Study Of Photodynamic Vaccination In Patients With Stage III/IV Malignant 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
Graeme R. Boniface, PhD
United States: Federal Government
|University of Colorado Cancer Center||Denver, Colorado 80262|
|Barbara Ann Karmanos Cancer Institute||Detroit, Michigan 48201|
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|Mount Sinai Comprehensive Cancer Center||Miami Beach, Florida 33140|
|Missouri Baptist Cancer Center||St. Louis, Missouri 63131|
|Mount Sinai Comprehensive Cancer Center at Aventura||Aventura, Florida 33180|