KeloidPhase 2NCT01408953
Therapeutic Study of Bevacizumab Injection Directly Inside the Keloid Tissue
A Phase 2 study testing bevacizumab in people with Keloid, run by Tirgan, Michael H., M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Keloid
- What is being tested?
- bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Keloid
- Being tested
- bevacizumab
- Keywords
- Keloid
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabBiological
Also called Avastin is the brand name for 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.
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab for all patients | Experimental | This is a single arm trial. All patients receive treatment with bevacizumab. Receives: Biological: bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2011 (estimated)
- Study startFeb 2012
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Very low accrual rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeloidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tirgan, Michael H., M.D.
- Responsible party
- Sponsor
- Investigators
- Michael H Tirgan, MD, Study chair, Keloid Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01408953
- Sponsor's protocol ID
- Tirgan 11-03
- Status last verified
- Oct 2016
- First submitted
- 29 Jul 2011
- Last updated
- 18 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Only two patients were treated on this study, neither responded. The study was closed due to difficulties in accruing patients.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Therapeutic Trial of Intralesional Bevacizumab in Patients With Non-pedunculated Keloids
- ClinicalTrials.gov ID
- NCT01408953
- Acronym / sponsor ID
- Tirgan 11-03
- Conditions
- Keloid
- Keywords
- Keloid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Very low accrual rate.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Tirgan, Michael H., M.D.
- Study start
- Feb 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 3 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bevacizumab for all patients | Experimental | Biological: bevacizumabThis is a single arm trial. All patients receive treatment with bevacizumab. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bevacizumabAlso: Avastin is the brand name for 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. | Biological | bevacizumab for all patients |
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.
1 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
Results and safety
The study was stopped early (reason given: Very low accrual rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2016.
- Individual participant dataSharing planned: Yes. Only two patients were treated on this study, neither responded. The study was closed due to difficulties in accruing patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H Tirgan, MD study chair
Keloid Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bevacizumab in people with Keloid, run by Tirgan, Michael H., M.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Very low accrual rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this trial is to demonstrate the response rate of non-pedunculated keloids to bevacizumab. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2016.