Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma
Study Details
Study Description
Brief Summary
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 |
---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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 longest dimension Measurable disease by calipers or CT scan No CNS metastases by CT scan
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
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Colorado Cancer Center | Denver | Colorado | United States | 80010 |
2 | Mount Sinai Comprehensive Cancer Center at Aventura | Aventura | Florida | United States | 33180 |
3 | Mount Sinai Comprehensive Cancer Center | Miami Beach | Florida | United States | 33140 |
4 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
5 | Missouri Baptist Cancer Center | Saint Louis | Missouri | United States | 63131 |
6 | University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | United States | 15213-3489 |
Sponsors and Collaborators
- QLT Inc.
Investigators
- Study Chair: Graeme R. Boniface, PhD, QLT Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000068358
- QLT-VFI-PDV-01
- QLT-PHO-VFI-PDV-01