Clinical Trial: Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Therapeutic Trial of Intralesional Bevacizumab in Patients With Non-pedunculated Keloids

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: Tirgan, Michael H., M.D.

Current Primary Outcome: The primary endpoint of this trial is to demonstrate the response rate of non-pedunculated keloids to bevacizumab. [ Time Frame: 1 year ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary endpoint of this trial is to demonstrate the rate of AE and SAE following intralesional Injections of bevacizumab. [ Time Frame: 1 Year ]

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.


Original Secondary Outcome: Same as current

Information By: Tirgan, Michael H., M.D.

Dates:
Date Received: July 29, 2011
Date Started: February 2012
Date Completion:
Last Updated: October 17, 2016
Last Verified: October 2016