Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind 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 |
| Study Completion Date: | March 2004 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
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 |
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 More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00049959 History of Changes |
| Other Study ID Numbers: | VFI MBCC 01 and VFI MBCC 02 |
| Study First Received: | November 15, 2002 |
| Last Updated: | March 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by QLT Inc.:
|
Verteporfin PDT multiple basal cell carcinoma nevoid basal cell carcinoma syndrome |
Additional relevant MeSH terms:
|
Basal Cell Nevus Syndrome Eye Abnormalities Tooth Abnormalities Carcinoma Carcinoma, Basal Cell Hamartoma Syndrome, Multiple Odontogenic Cysts Jaw Cysts Bone Cysts Cysts Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms, Basal Cell Neoplastic Syndromes, Hereditary |
Bone Diseases, Developmental Bone Diseases Musculoskeletal Diseases Jaw Diseases Stomatognathic Diseases Abnormalities, Multiple Congenital Abnormalities Genetic Diseases, Inborn Eye Diseases Stomatognathic System Abnormalities Tooth Diseases Hamartoma Neoplasms, Multiple Primary Verteporfin Photosensitizing Agents |
ClinicalTrials.gov processed this record on May 22, 2013