Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
QLT Inc Novartis |
---|---|
Information provided by: | QLT Inc |
ClinicalTrials.gov Identifier: | NCT00049959 |
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 |
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 |
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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Verteporfin PDT multiple basal cell carcinoma nevoid basal cell carcinoma syndrome |
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 |
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 |