Trial record 3 of 15 for:    "Nevoid basal cell carcinoma syndrome"

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

This study has been terminated.
Sponsor:
Collaborator:
Novartis
Information provided by:
QLT Inc.
ClinicalTrials.gov Identifier:
NCT00049959
First received: November 15, 2002
Last updated: March 1, 2011
Last verified: March 2011
  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

Resource links provided by NLM:


Further study details as provided by QLT Inc.:

Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 July 20, 2014