Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.

NCT ID: NCT00049959

Last Updated: 2011-03-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2004-03-31

Brief Summary

The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.

Detailed Description

Basal cell carcinoma (BCC) of the skin is the most common type of cancer that can be treated with various therapies including surgical removal. A number of factors can lead to the development of multiple BCC of the skin, including genetic disorders (e.g., nevoid basal cell carcinoma syndrome). Treatment of multiple BCC becomes much more challenging. In these trials, the experimental therapy: verteporfin PDT is compared to placebo PDT. PDT or photodynamic therapy in these studies is the combination of the photoactive drug verteporfin (given intravenously) and red light exposure of skin tumors.

The primary objective is to assess whether verteporfin PDT can completely eliminate multiple BCCs. Eligible subjects will have at least 3 BCCs. Study subjects won't know which treatment they have been been assigned to - this is done randomly (like flipping a coin). After study treatment, the BCCs in each subject will be closely observed and toward the end of the study all will be surgically removed and examined to verify response to study treatment. Safety will be assessed by testing blood samples before and after study treatment, and analyzing adverse events and skin reactions to the study treatment.

Conditions

Basal Cell Carcinoma; Nevoid Basal Cell Carcinoma Syndrome; Gorlin Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

verteporfin PDT

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Currently has at least 3 eligible BCC skin tumors that have never been treated
• Is willing to have these tumor sites surgically removed

Exclusion Criteria

• Has xeroderma pigmentosum
• Has BCC tumors that are the result of prior radiotherapy or immunosuppression due to an organ transplant
• Is immunosuppressed
• Has abnormal liver function
• Is receiving systemic chemotherapy or has received chemotherapy within the last two years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

QLT Inc.

INDUSTRY

Sponsor Role: lead

Principal Investigators

Herma Neyndorff

Role: STUDY_DIRECTOR

QLT Inc.

Other Identifiers

VFI MBCC 01 and VFI MBCC 02

Identifier Type: -

Identifier Source: org_study_id