Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.
Primary Purpose
Basal Cell Carcinoma, Nevoid Basal Cell Carcinoma Syndrome, Gorlin Syndrome
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
verteporfin PDT
Sponsored by
About this trial
This is an interventional treatment trial for Basal Cell Carcinoma focused on measuring Verteporfin PDT, multiple basal cell carcinoma, nevoid basal cell carcinoma syndrome
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00049959
First Posted
November 15, 2002
Last Updated
March 1, 2011
Sponsor
QLT Inc.
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00049959
Brief Title
Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Study Start Date
undefined (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
QLT Inc.
Collaborators
Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Basal Cell Carcinoma, Nevoid Basal Cell Carcinoma Syndrome, Gorlin Syndrome
Keywords
Verteporfin PDT, multiple basal cell carcinoma, nevoid basal cell carcinoma syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
verteporfin PDT
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herma Neyndorff
Organizational Affiliation
QLT Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.
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