Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue
Keloid is chronic skin conditions that results in formation of tumor like growths on the skin. Despite its benign nature, keloid can cause severe aesthetic and, in some cases, functional problem which negatively impacts person's quality of life.
Keloids do not regress on their own and results of most available treatments such as surgery, injecting keloids with steroids, chemotherapy injections, or even radiation therapy, have mostly proven disappointing.
Some laboratory studies have shown that there is excessive amount of a protein called "vascular endothelial growth factor (VEGF)" in keloid tissue. This may play role in the formation and evolution of keloid.
Bevacizumab is a drug that works by targeting vascular endothelial growth factor (VEGF) which helps new blood vessels form. Without new blood vessels, the growth of the keloid may be slowed
Based on presence of excess amount of VEGF in keloid tissue, we hypothesize that bevacizumab will be effective in treatment of keloids. This exploratory clinical trial is to confirm or reject this hypothesis.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Therapeutic Trial of Intralesional Bevacizumab in Patients With Non-pedunculated Keloids|
- The primary endpoint of this trial is to demonstrate the response rate of non-pedunculated keloids to bevacizumab. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]The primary objective of this trial is to demonstrate the efficacy of bevacizumab in patients with non-pedunculated keloids. Patients will be followed for one year since their last bevacizumab to assess post-therapy duration of response as well as the rate of recurrence.
- The secondary endpoint of this trial is to demonstrate the rate of AE and SAE following intralesional Injections of bevacizumab. [ Time Frame: 1 Year ] [ Designated as safety issue: Yes ]The secondary objective of this trial is to demonstrate safety of intralesional bevacizumab. Patients will be followed for one year after their last bevacizumab to assess safety of the treatment.
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: bevacizumab for all patients
This is a single arm trial. All patients receive treatment with bevacizumab.
Bevacizumab will be diluted with 0.9% Sodium Chloride to achieve a concentration of 1 mg/0.3 ml. Bevacizumab will be injected inside ONE keloid tissue to result in a visual expansion of the keloid. Only 1 mg of bevacizumab is injected inside ONE keloid. The injections will be repeated every 14 days. Patients will receive maximum of 12 injections only.
A log will be kept for each patient indicating the date and the dose of bevacizumab that was delivered to each patient.
Other Name: Avastin is the brand name for bevacizumab.
Sixty Eligible patients will be enrolled in the study. This will be a two stage design trial.
In stage I of the trial, 21 patients will be treated with intralesional bevacizumab. Keloids that fail to respond to 4 injections will not be treated any longer with bevacizumab and all such patients will be removed from the trial.
If 5 or more patients show some degree of objective response to treatment in at least one treated keloid, the trial will continue to enroll another 45 patients to a total of 66 patients, otherwise, the trial will stop in its entirety.
|United States, New York|
|Michael H. Tirgan, MD|
|New York, New York, United States, 10023|
|Study Chair:||Michael H Tirgan, MD||Keloid Research Foundation|