Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II, Phase I Treatment Completed Over 18 Pharmaceutical / Industry QLT-VFI-PDV-01 QLT-PHO-VFI-PDV-01, NCT00007969

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.

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 longest
  dimension
 
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

Expected Enrollment

A total of 30 patients will be accrued for this study within 12 months.

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.

Trial Contact Information

Trial Lead Organizations

QLT, Incorporated

Graeme R. Boniface, PhD, Protocol chair		Ph: 604-707-7497; 800-663-5486

Registry Information
Official Title		A Phase 1/2 Uncontrolled, Open Label Study Of Photodynamic Vaccination In Patients With Stage III/IV Malignant Melanoma
Trial Start Date		2000-10-01
Registered in ClinicalTrials.gov		NCT00007969
Date Submitted to PDQ		2000-11-08
Information Last Verified		2008-08-15