Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue - Full Text View

Sponsor:	Tirgan, Michael H., M.D.
Information provided by (Responsible Party):	Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier:	NCT01408953

Purpose

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.

Condition	Intervention	Phase
Keloid	Biological: bevacizumab	Phase 2

Study Type:	Interventional
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

Resource links provided by NLM:

Drug Information available for: Bevacizumab

U.S. FDA Resources

Further study details as provided by Tirgan, Michael H., M.D.:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	66
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)

Arms	Assigned Interventions
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 Name: Avastin is the brand name for bevacizumab.

Arms

Assigned Interventions

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 Name: Avastin is the brand name for 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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01408953

Contacts

Contact: Michael H Tirgan, MD

(212) 874 4200

htirgan@aol.com

Locations

United States, New York
Michael H. Tirgan, MD	Recruiting
New York, New York, United States, 10023
Contact: Michael H Tirgan, MD 212-874-4200 htirgan@aol.com
Principal Investigator: Michael H Tirgan, MD

Sponsors and Collaborators

Tirgan, Michael H., M.D.

Investigators

Principal Investigator:

Michael H Tirgan, MD

St. Luke's-Roosevelt Hospital, New York City

More Information

Additional Information:

Official Website of This Trial This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Tirgan, Michael H., M.D.
ClinicalTrials.gov Identifier:	NCT01408953 History of Changes
Other Study ID Numbers:	Tirgan 11-03
Study First Received:	July 29, 2011
Last Updated:	February 29, 2012
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by Tirgan, Michael H., M.D.:

Keloid

Additional relevant MeSH terms:

Keloid
Collagen Diseases
Connective Tissue Diseases
Cicatrix
Fibrosis
Pathologic Processes
Bevacizumab
Angiogenesis Inhibitors

Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012