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Two Studies to Determine If Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.
This study has been terminated.
Sponsors and Collaborators: QLT Inc
Novartis
Information provided by: QLT Inc
ClinicalTrials.gov Identifier: NCT00049959
  Purpose

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 Intervention Phase
Basal Cell Carcinoma
Nevoid Basal Cell Carcinoma Syndrome
Gorlin Syndrome
Drug: verteporfin PDT
Phase III

Genetics Home Reference related topics: Gorlin syndrome
Drug Information available for: Verteporfin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by QLT Inc:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00049959

Sponsors and Collaborators
QLT Inc
Novartis
Investigators
Study Director: Herma Neyndorff QLT Inc
  More Information

QLT,Inc. Study Page  This link exits the ClinicalTrials.gov site

Study ID Numbers: VFI MBCC 01 and VFI MBCC 02
Study First Received: November 15, 2002
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00049959  
Health Authority: United States: Food and Drug Administration

Keywords provided by QLT Inc:
Verteporfin PDT
multiple basal cell carcinoma
nevoid basal cell carcinoma syndrome

Study placed in the following topic categories:
Verteporfin
Carcinoma, Basal Cell
Cysts
Bone Diseases
Carcinoma
Nevoid basal cell carcinoma syndrome
Basal Cell Nevus Syndrome
Neoplastic Syndromes, Hereditary
Genetic Diseases, Inborn
Musculoskeletal Diseases
Nevus, Pigmented
Bone Cysts
Abnormalities, Multiple
Bone Diseases, Developmental
Nevus
Stomatognathic Diseases
Congenital Abnormalities
Basal cell carcinoma, multiple
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Disease
Physiological Effects of Drugs
Jaw Diseases
Jaw Cysts
Pharmacologic Actions
Odontogenic Cysts
Neoplasms
Photosensitizing Agents
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Syndrome
Neoplasms, Basal Cell
Dermatologic Agents

ClinicalTrials.gov processed this record on January 15, 2009