Back to resultsTherapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue
Primary Purpose
Keloid
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
Sponsored by
About this trial
This is an interventional treatment trial for Keloid focused on measuring Keloid
Eligibility 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
Sites / Locations
- Michael H. Tirgan, MD
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
bevacizumab for all patients
Arm Description
This is a single arm trial. All patients receive treatment with bevacizumab.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01408953
First Posted
July 29, 2011
Last Updated
October 17, 2016
Sponsor
Tirgan, Michael H., M.D.
1. Study Identification
Unique Protocol Identification Number
NCT01408953
Brief Title
Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue
Official Title
A Therapeutic Trial of Intralesional Bevacizumab in Patients With Non-pedunculated Keloids
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Very low accrual rate.
Study Start Date
February 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tirgan, Michael H., M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keloid
Keywords
Keloid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
bevacizumab for all patients
Arm Type
Experimental
Arm Description
This is a single arm trial. All patients receive treatment with bevacizumab.
Intervention Type
Biological
Intervention Name(s)
bevacizumab
Other Intervention Name(s)
Avastin is the brand name for bevacizumab.
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint of this trial is to demonstrate the response rate of non-pedunculated keloids to bevacizumab.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The secondary endpoint of this trial is to demonstrate the rate of AE and SAE following intralesional Injections of bevacizumab.
Description
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.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Tirgan, MD
Organizational Affiliation
Keloid Research Foundation
Official's Role
Study Chair
Facility Information:
Facility Name
Michael H. Tirgan, MD
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Only two patients were treated on this study, neither responded. The study was closed due to difficulties in accruing patients.
Learn more about this trial
Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue
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