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

Melanoma (Skin) Clinical Trial

Official title:

A Phase 1/2 Uncontrolled, Open Label Study Of Photodynamic Vaccination In Patients With Stage III/IV Malignant Melanoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007969
• Other study ID #: CDR0000068358
• Secondary ID: QLT-VFI-PDV-01QL
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: January 6, 2001
• Last updated: November 5, 2013
• Start date: October 2000

Study information

• Verified date: August 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)

Intervention

Biological:
• Detox-B adjuvant

Drug:
• verteporfin

Locations

Country	Name	City	State
United States	Mount Sinai Comprehensive Cancer Center at Aventura	Aventura	Florida
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Mount Sinai Comprehensive Cancer Center	Miami Beach	Florida
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Missouri Baptist Cancer Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
QLT Inc.

Country where clinical trial is conducted

United States,