Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
|ClinicalTrials.gov Identifier: NCT00007969|
Recruitment Status : Completed
First Posted : March 11, 2004
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Melanoma (Skin)||Biological: Detox-B adjuvant Drug: verteporfin||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase 1/2 Uncontrolled, Open Label Study Of Photodynamic Vaccination In Patients With Stage III/IV Malignant Melanoma|
|Study Start Date :||October 2000|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007969
|United States, Colorado|
|University of Colorado Cancer Center|
|Denver, Colorado, United States, 80010|
|United States, Florida|
|Mount Sinai Comprehensive Cancer Center at Aventura|
|Aventura, Florida, United States, 33180|
|Mount Sinai Comprehensive Cancer Center|
|Miami Beach, Florida, United States, 33140|
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|United States, Missouri|
|Missouri Baptist Cancer Center|
|Saint Louis, Missouri, United States, 63131|
|United States, Pennsylvania|
|University of Pittsburgh Cancer Institute|
|Pittsburgh, Pennsylvania, United States, 15213-3489|
|Study Chair:||Graeme R. Boniface, PhD||QLT Inc.|