Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity
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| ClinicalTrials.gov Identifier: NCT01296815 |
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Recruitment Status :
Completed
First Posted : February 16, 2011
Results First Posted : July 27, 2015
Last Update Posted : July 27, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kaposi´s Sarcoma | Drug: Bevacizumab | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Intralesional Bevacizumab for Treating AIDS-associated Kaposi´s Sarcoma of the Larynx, Pharynx and Oral Cavity |
| Study Start Date : | September 2010 |
| Actual Primary Completion Date : | December 2012 |
| Actual Study Completion Date : | December 2013 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: HAART
Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
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Experimental: 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.
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Drug: Bevacizumab
Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
Other Name: Avastin |
- Number of Participants With Complete Response [ Time Frame: 12 months ]Complete response will be assessed according to RECIST criteria
- Safety [ Time Frame: 12 months ]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.
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| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV infected
- KS of the oral cavity, pharynx and larynx, histopathologically confirmed
- HIV treatment-naïve
Exclusion Criteria:
- Airway obstructive lesions
- Actively bleeding lesions
- Tumor-associated oedema or ulceration
- Gastrointestinal KS
- KS in other nonnodal viscera
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01296815
| Mexico | |
| Centro de Investigacion en Enfermedades Infecciosas | |
| Mexico, Mexico, 14080 | |
| Study Director: | Gustavo Reyes-Teran, M.D. | Centro de Investigacion en Enfermedades Infecciosas | |
| Principal Investigator: | Yuria Ablanedo-Terrazas, M.D. | Centro de Investigacion en Enfermedades Infecciosas |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico |
| ClinicalTrials.gov Identifier: | NCT01296815 History of Changes |
| Other Study ID Numbers: |
C41-10 |
| First Posted: | February 16, 2011 Key Record Dates |
| Results First Posted: | July 27, 2015 |
| Last Update Posted: | July 27, 2015 |
| Last Verified: | July 2015 |
Keywords provided by Gustavo Reyes-Teran, Centro de Investigación en. Enfermedades Infecciosas, Mexico:
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Kaposi sarcoma HIV Bevacizumab |
Additional relevant MeSH terms:
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Sarcoma Sarcoma, Kaposi AIDS-Related Opportunistic Infections Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Herpesviridae Infections DNA Virus Infections Virus Diseases Neoplasms, Vascular Tissue Opportunistic Infections Infection HIV Infections Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Parasitic Diseases Immunologic Deficiency Syndromes Immune System Diseases Bevacizumab Anti-Retroviral Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents Antiviral Agents Anti-Infective Agents |