Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
NCT ID: NCT01296815
Last Updated: 2015-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2010-09-30
2013-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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HAART
Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
No interventions assigned to this group
HAART+ Bevacizumab injection
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.
Bevacizumab
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Interventions
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Bevacizumab
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* KS of the oral cavity, pharynx and larynx, histopathologically confirmed
* HIV treatment-naïve
Exclusion Criteria
* Actively bleeding lesions
* Tumor-associated oedema or ulceration
* Gastrointestinal KS
* KS in other nonnodal viscera
18 Years
60 Years
ALL
No
Sponsors
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Centro de Investigación en. Enfermedades Infecciosas, Mexico
OTHER_GOV
Responsible Party
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Gustavo Reyes-Teran
Gustavo Reyes-Teran
Principal Investigators
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Gustavo Reyes-Teran, M.D.
Role: STUDY_DIRECTOR
Centro de Investigacion en Enfermedades Infecciosas
Yuria Ablanedo-Terrazas, M.D.
Role: PRINCIPAL_INVESTIGATOR
Centro de Investigacion en Enfermedades Infecciosas
Locations
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Centro de Investigacion en Enfermedades Infecciosas
México, State of Mexico, Mexico
Countries
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References
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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.
Other Identifiers
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C41-10
Identifier Type: -
Identifier Source: org_study_id
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