Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue

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

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 Overview

• Status: Terminated
• Conditions: Keloid
• Intervention / Treatment: Biological: bevacizumab

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10023
      • Michael H. Tirgan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinical Diagnosis of a flat keloid.
2. Age 18 to 50
3. A signed informed consent document (ICD)
4. Able and willing to receive bevacizumab

Women of child-bearing potential must have a negative pregnancy test during screening. The effects of bevacizumab on the developing human fetus are unknown. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.

Exclusion Criteria:

1. Pedunculated Keloid
2. Diastolic Blood pressure of 90 mm Hg or above
3. History of any degree of Hypertension, even medically controlled hypertension
4. History of any form of cardiovascular disease or stroke
5. History of any form of thromboembolic event
6. History of renal dysfunction or proteinuria
7. History of recent (past 12 month) or planned (next 3 months) major surgery,
8. Men and women who plan to have children within 6 months of their last treatment
9. Psychological Illness that may result in non compliance with treatment
10. Pregnancy and Breast Feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: bevacizumab for all patients; This is a single arm trial. All patients receive treatment with bevacizumab.

Biological: 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 Names: Avastin is the brand name for bevacizumab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint of this trial is to demonstrate the response rate of non-pedunculated keloids to bevacizumab.	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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary endpoint of this trial is to demonstrate the rate of AE and SAE following intralesional Injections of bevacizumab.	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.	1 Year

Collaborators and Investigators

• Sponsor: Tirgan, Michael H., M.D.
• Investigators: Study Chair: Michael H Tirgan, MD, Keloid Research Foundation

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: July 29, 2011
• First Submitted That Met QC Criteria: August 2, 2011
• First Posted (Estimate): August 3, 2011

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Keloid
• Additional Relevant MeSH Terms: Pathologic Processes; Connective Tissue Diseases; Fibrosis; Cicatrix; Collagen Diseases; Keloid; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: Tirgan 11-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Only two patients were treated on this study, neither responded. The study was closed due to difficulties in accruing patients.