Kaposi´s SarcomaPhase 2NCT01296815
Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
A Phase 2 study testing Bevacizumab in people with Kaposi´s Sarcoma, run by Centro de Investigación en. Enfermedades Infecciosas, Mexico at 1 site in Mexico.
Trial summary
Kaposi sarcoma remains the most common malignancy among persons with HIV. Lesions localized to the airway may cause bleeding, pain and dyspnea. New therapeutic approaches for local disease are needed. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Kaposi´s Sarcoma
- 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
- 14 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- HIV infected
- KS of the oral cavity, pharynx and larynx, histopathologically confirmed
- HIV treatment-naïve
Who cannot join
- Airway obstructive lesions
- Actively bleeding lesions
- Tumor-associated oedema or ulceration
- Gastrointestinal KS
- KS in other nonnodal viscera
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro de Investigacion en Enfermedades Infecciosas
México, State of Mexico, 14080
About this study
Kaposi sarcoma remains the most common malignancy among persons with HIV.
Lesions localized to the airway may cause bleeding, pain and dyspnea.
New therapeutic approaches for local disease are needed.
The purpose of this study is to compare the effectiveness of intralesional bevacizumab + HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with AIDS.
Read the detailed description
Once disseminated disease is excluded, histologically confirmed HIV-positive patients with localized Kaposi's sarcoma of the airway will be randomized to receive HAART only or HAART + intralesional bevacizumab.
The primary outcome will be the size of lesions according to RECIST criteria. Patients in the HAART + bevacizumab arm will undergo series of 3 bevacizumab injections of 5 mg/cm3. Follow-up will be carried out through scheduled meetings for office setting examination every week for the first 8 weeks, then every 15 days for two months and finally every month for eight months.
Size of the lesions will be assessed by an independent observer and adverse events will be recorded.
- Conditions
- Kaposi´s Sarcoma
- Being tested
- Bevacizumab
- Keywords
- Kaposi sarcoma, HIV, Bevacizumab
- Medical subject headings
- Sarcoma, Kaposi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
| Study group | Role | What they receive |
|---|---|---|
| HAART | No intervention | Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents |
| HAART+ Bevacizumab injection | Experimental | Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Patients received 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) in the target lesion every 2 weeks. Bevacizumab was injected using an insulin syringe in a submucosal plane. The volume injected was based on the size of the target lesion; the dose was 0.2 mL (5 mg) per cm2. Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Response
Complete response will be assessed according to RECIST criteria
Measured: 12 months
Secondary outcomes (1)
Safety
Adverse events will be assessed according to the Council for International Organizations of Medical Sciences (CIOMS) I Working Group the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kaposi´s SarcomaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico
- Investigators
- Gustavo Reyes-Teran, M.D., Study director, Centro de Investigacion en Enfermedades InfecciosasYuria Ablanedo-Terrazas, M.D., Principal investigator, Centro de Investigacion en Enfermedades Infecciosas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296815
- Sponsor's protocol ID
- C41-10
- Status last verified
- Jul 2015
- First submitted
- 15 Feb 2011
- Last updated
- 27 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Ablanedo-Terrazas Y, Alvarado-de la Barrera C, Ormsby CE, Ruiz-Cruz M, Reyes-Teran G. Intralesional bevacizumab in patients with human immunodeficiency virus-associated Kaposi's sarcoma in the upper airway. Laryngoscope. 2015 Apr;125(4):E132-7. doi: 10.1002/lary.24988. Epub 2014 Oct 27.
PubMed 25345840
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
- ClinicalTrials.gov ID
- NCT01296815
- Acronym / sponsor ID
- C41-10
- Conditions
- Kaposi´s Sarcoma
- Keywords
- Kaposi sarcoma, HIV, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centro de Investigación en. Enfermedades Infecciosas, MexicoOther government
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Posted 27 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Kaposi sarcoma remains the most common malignancy among persons with HIV.
Lesions localized to the airway may cause bleeding, pain and dyspnea.
New therapeutic approaches for local disease are needed.
The purpose of this study is to compare the effectiveness of intralesional bevacizumab + HAART vs HAART alone in treating localized Kaposi´s sarcoma of the airway in patients with AIDS.
Detailed description
Once disseminated disease is excluded, histologically confirmed HIV-positive patients with localized Kaposi's sarcoma of the airway will be randomized to receive HAART only or HAART + intralesional bevacizumab.
The primary outcome will be the size of lesions according to RECIST criteria. Patients in the HAART + bevacizumab arm will undergo series of 3 bevacizumab injections of 5 mg/cm3. Follow-up will be carried out through scheduled meetings for office setting examination every week for the first 8 weeks, then every 15 days for two months and finally every month for eight months.
Size of the lesions will be assessed by an independent observer and adverse events will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAART | No intervention | –Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents |
| HAART+ Bevacizumab injection | Experimental | Drug: BevacizumabPatients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents. Patients received 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) in the target lesion every 2 weeks. Bevacizumab was injected using an insulin syringe in a submucosal plane. The volume injected was based on the size of the target lesion; the dose was 0.2 mL (5 mg) per cm2. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- HIV infected
- KS of the oral cavity, pharynx and larynx, histopathologically confirmed
- HIV treatment-naïve
Key exclusion criteria (5 listed)
- Airway obstructive lesions
- Actively bleeding lesions
- Tumor-associated oedema or ulceration
- Gastrointestinal KS
- KS in other nonnodal viscera
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: AvastinIntralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3 | Drug | HAART+ Bevacizumab injection |
Primary outcome
Number of Participants With Complete Response
Time frame: 12 months
Complete response will be assessed according to RECIST criteria
1 secondary outcome
Safety
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25345840Ablanedo-Terrazas Y, Alvarado-de la Barrera C, Ormsby CE, Ruiz-Cruz M, Reyes-Teran G. Intralesional bevacizumab in patients with human immunodeficiency virus-associated Kaposi's sarcoma in the upper airway. Laryngoscope. 2015 Apr;125(4):E132-7. doi: 10.1002/lary.24988. Epub 2014 Oct 27.
Related trials for Kaposi´s Sarcoma
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Natural History of KSHV-Associated Multicentric Castleman s Disease
Multicentric Castleman s Disease
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.
Gustavo Reyes-Teran, M.D. study director
Centro de Investigacion en Enfermedades Infecciosas
Yuria Ablanedo-Terrazas, M.D. principal investigator
Centro de Investigacion en Enfermedades Infecciosas
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 Kaposi´s Sarcoma, run by Centro de Investigación en. Enfermedades Infecciosas, Mexico at 1 site in Mexico.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jul 2015. 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 Mexico. 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?
Yes. Results are posted in the registry (first posted 27 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Response (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296815, which also lists 1 linked publication.
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 27 Jul 2015.