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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
QLT Inc.
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 15, 2002
    Last Updated
    March 1, 2011
    Sponsor
    QLT Inc.
    Collaborators
    Novartis
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    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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