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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00049959
Other study ID # VFI MBCC 01 and VFI MBCC 02
Secondary ID
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


Intervention

Drug:
verteporfin PDT


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
QLT Inc. Novartis
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