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

Phase 3

Terminated

• Conditions: Gorlin Syndrome; Nevoid Basal Cell Carcinoma Syndrome; Basal Cell Carcinoma

• Registration Number: NCT00049959
• Lead Sponsor: QLT Inc.

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.

Study Timeline

• Study First Submitted: 2002-11-15
• Study First Submitted QC: 2002-11-18
• Study First Posted: 2002-11-19
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Status Verified: 2011-03
• Disposition First Submitted: 2011-03-01
• Disposition First Submitted QC: 2011-03-01
• Last Update Submitted: 2011-03-01
• Disposition First Posted: 2011-03-16
• Last Update Posted: 2011-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL