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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049959
Recruitment Status : Terminated
First Posted : November 19, 2002
Last Update Posted : March 16, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Basal Cell Carcinoma Nevoid Basal Cell Carcinoma Syndrome Gorlin Syndrome Drug: verteporfin PDT Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
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
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00049959

Sponsors and Collaborators
QLT Inc.
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Study Director: Herma Neyndorff QLT Inc.
Layout table for additonal information Identifier: NCT00049959    
Other Study ID Numbers: VFI MBCC 01 and VFI MBCC 02
First Posted: November 19, 2002    Key Record Dates
Last Update Posted: March 16, 2011
Last Verified: March 2011
Keywords provided by QLT Inc.:
Verteporfin PDT
multiple basal cell carcinoma
nevoid basal cell carcinoma syndrome
Additional relevant MeSH terms:
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Carcinoma, Basal Cell
Basal Cell Nevus Syndrome
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Odontogenic Cysts
Jaw Cysts
Bone Cysts
Neoplastic Syndromes, Hereditary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Jaw Diseases
Stomatognathic Diseases
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Photosensitizing Agents
Dermatologic Agents