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	Treatment or Intervention	Phase
Stage IV Melanoma stage III melanoma Recurrent Melanoma	Drug: Detox-B adjuvant  Drug: verteporfin	Phase I Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Diagnosis of stage III or IV melanoma
• At least 3 cutaneous tumors for treatment (treatment tumors) AND 1-7 additional cutaneous, visceral, or lymph node tumors for response assessment (marker tumors); Treatment tumors must be on trunk, arms, or legs AND be 1.0-3.6 cm in
• Measurable disease by calipers or CT scan
• No CNS metastases by CT scan

--Prior/Concurrent Therapy--

• Biologic therapy: At least 4 weeks since prior biologic therapy or immunotherapy; No concurrent biologic therapy
• Chemotherapy: At least 4 weeks since prior chemotherapy; No concurrent chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: At least 4 weeks since prior radiotherapy; No concurrent radiotherapy
• Surgery: No concurrent surgical removal of melanoma lesions designated for treatment or response assessment
• Other: No other concurrent therapy for melanoma

--Patient Characteristics--

• Age: Over 18
• Performance status: ECOG 0-2
• Life expectancy: Not specified
• Hematopoietic: WBC at least 2,500/mm3; Neutrophil count at least 1,000/mm3; Platelet count at least 50,000/mm3; Hemoglobin at least 9 g/dL; Hematocrit at least 27%
• Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN); AST/ALT no greater than 2 times ULN; Alkaline phosphatase no greater than 2.5 times ULN
• Renal: Creatinine no greater than 2 times ULN

Colorado
      University of Colorado Cancer Center, Denver,  Colorado,  80010,  United States
Florida
      Mount Sinai Comprehensive Cancer Center, Miami Beach,  Florida,  33140,  United States
      Mount Sinai Comprehensive Cancer Center at Aventura, Aventura,  Florida,  33180,  United States
Michigan
      Barbara Ann Karmanos Cancer Institute, Detroit,  Michigan,  48201-1379,  United States
Missouri
      Missouri Baptist Cancer Center, Saint Louis,  Missouri,  63131,  United States
Pennsylvania
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213-3489,  United States

Study chairs or principal investigators

Graeme R. Boniface,  Study Chair,  QLT Inc   

Study ID Numbers:  CDR0000068358; QLT-VFI-PDV-01; QLT-PHO-VFI-PDV-01
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00007969
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08