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

Basal Cell Carcinoma Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Masked, Multicenter Phase III Study Of Photodynamic Therapy With Verteporfin For Injection (VFI) For The Treatment Of Multiple Basal Cell Carcinoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00049959
• Other study ID #: VFI MBCC 01 and VFI MBCC 02
• Status: Terminated
• Phase: Phase 3
• First received: November 15, 2002
• Last updated: March 1, 2011
• Est. completion date: March 2004

Study information

• Verified date: March 2011
• Source: QLT Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Basal Cell Nevus Syndrome
• Carcinoma
• Carcinoma, Basal Cell
• Gorlin Syndrome
• Hamartoma Syndrome, Multiple
• Nevoid Basal Cell Carcinoma Syndrome
• Syndrome

Intervention

Drug:
• verteporfin PDT

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
QLT Inc.	Novartis

External Links

•   QLT,Inc. Study Page