Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue

NCT01408953 | Terminated Phase 2

• 1 other identifier: Tirgan 11-03
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Keloid

Keywords

Keloid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The secondary endpoint of this trial is to demonstrate the rate of AE and SAE following intralesional Injections of bevacizumab.

  1 Year

Study Arms (1)

bevacizumab for all patients

EXPERIMENTAL

This is a single arm trial. All patients receive treatment with bevacizumab.

Biological: bevacizumab

Interventions

bevacizumab BIOLOGICAL

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.

Also known as: Avastin is the brand name for bevacizumab.

bevacizumab for all patients

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical Diagnosis of a flat keloid.
• Age 18 to 50
• A signed informed consent document (ICD)
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tirgan, Michael H., M.D.: lead

Study Sites (1)

Michael H. Tirgan, MD

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

Keloid

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michael H Tirgan, MD

  Keloid Research Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2011
• First Posted: August 3, 2011
• Study Start: February 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: October 18, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)