Overview

Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
QLT Inc.
Treatments:
Detox adjuvant
Verteporfin
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